vivo comparative efficacy of three surgical hand preparation agents
Transcrição
vivo comparative efficacy of three surgical hand preparation agents
Journal of Hospital Infection 86 (2014) 64e67 Available online at www.sciencedirect.com Journal of Hospital Infection journal homepage: www.elsevierhealth.com/journals/jhin In vivo comparative efficacy of three surgical hand preparation agents in reducing bacterial count P. Barbadoro a, b, E. Martini a, S. Savini a, A. Marigliano b, E. Ponzio b, E. Prospero a, b, *, M.M. D’Errico a, b a Hospital Hygiene Service, Ospedali Riuniti, Ancona, Italy Department of Biomedical Sciences and Public Health, Unit of Hygiene, Preventive Medicine and Public Health, Università Politecnica delle Marche, Ancona, Italy b A R T I C L E I N F O Article history: Received 18 June 2013 Accepted 23 September 2013 Available online 16 October 2013 Keywords: Alcohol-based hand rub Antiseptics Efficacy Surgical hand hygiene S U M M A R Y Background: Besides objective efficacy, the choice between an antiseptic-based liquid soap, or an alcohol-based hand rub for surgical hand preparation technique is based on personal preference. Glycerol is often added to the formulations in order to enhance tolerability; however, it has been recently reported as a factor reducing the sustained effect of surgical hand rubs. Aim: To compare the efficacies of three commercial products for hand decontamination. Methods: The in vivo efficacy of an alcohol-based hand rub (isopropyl alcohol 40%; Npropyl alcohol 25%; glycerin 1.74%; triethanolamine salt of carbomer <1%) was compared with other widely used products in surgical hand antisepsis (chlorhexidine and povidoneiodine). All products were used according to the manufacturers’ instructions. Findings: The best results were achieved with the alcohol-based hand rub and these were sustained for a period of 3 h. Some volunteers experienced skin peeling off the hands when using alcohol-based hand rub; in this group of participants, the bacterial count was reduced only by 0.91 ! 1.67 log10 compared with 2.86 ! 1.22 log10 in the group who did not show this phenomenon. Conclusion: Besides confirming the importance of alcohol-based hand rubs for surgical hand decontamination, the results suggest the value of assessing the characteristics, and response of healthcare workers’ skin, that may contribute to the development of skin peeling, and the subsequent possibility of a paradoxical overcolonization of hands after surgical preparation with alcohol-based hand rub. ª 2013 The Healthcare Infection Society. Published by Elsevier Ltd. All rights reserved. Introduction Surgical site infections (SSIs) are still among the most common hospital-acquired infections worldwide despite * Corresponding author. Address: Dipartimento di Scienze Biomediche e Sanità Pubblica, Università Politecnica delle Marche, Via Tronto 10/a, 60020 Torrette di Ancona, Italy. Tel.: þ39 0712206030; fax: þ39 0712206032. E-mail address: [email protected] (E. Prospero). significant developments in surgical technique.1,2 Disinfection can be performed using a surgical hand wash with an antiseptic liquid soap, or with an alcohol-based hand rub.3,4 Products for surgical hand disinfection should pass two European standards for bactericidal efficacy: European Norm (EN) 12054, which is a suspension test using four different test bacteria to determine a general bactericidal activity; and EN 12791, which is a test used to determine the bactericidal efficacy in vivo.5e7 However, recently there has been a growing interest in challenging surgical handwashing procedure in real working settings, and 0195-6701/$ e see front matter ª 2013 The Healthcare Infection Society. Published by Elsevier Ltd. All rights reserved. http://dx.doi.org/10.1016/j.jhin.2013.09.013 P. Barbadoro et al. / Journal of Hospital Infection 86 (2014) 64e67 the formulations recommended by the World Health Organization have been discussed.8e10 Moreover, the glycerol component of alcohol-based hand rub has been recently evaluated as a factor reducing the sustained effect of surgical hand rubs.11 The objective of this work was to compare the in vivo efficacy of an alcohol formulation with respect to other widely used products in surgical hand antisepsis. Methods Products tested The tested products were based on the following formulations: (i) chlorhexidine (chlorhexidine gluconate 4%; propan-2ol 1e5%; lauryldimethylamine oxide 1e5%; glycerol 1e5%); (ii) povidone-iodine (7.5%); and (iii) an alcohol formulation (isopropyl alcohol 40%; N-propyl alcohol 25%; glycerin 1.74%; triethanolamine salt of carbomer <1%). The following neutralizers were used: polysorbate 80 (3%), saponin (0.3%), histidine (0.1%) and cysteine (0.1%). The in vivo bactericidal efficacy of the three products was assessed in 20 healthy volunteers aged 27e50 years. The skin of the volunteers was free from cuts or abrasions and no other skin disorders were present. Nails were short and clean. In three distinct cross-over experiments, each formulation containing one of the three products was tested. A washout period of one week was allowed between each test run. At the end of the four experiments, each volunteer had used each formulation once. Volunteers participated after having expressed a written informed consent. Wash phase (pre-values) To remove transient bacterial flora and foreign agents, volunteers’ hands were washed with a plain soap with the following procedure: 10 mL of the soap was poured into the cupped dry hands and rubbed vigorously on to the skin up to the wrists in accordance with the standard procedure to ensure total coverage of the hands, which were then rinsed in running tap water and dried with a sterile paper towel. For the determination of the pre-values of colony-forming units (cfu), the distal phalanges of the right and left hand were rubbed separately, including thumbs, for 1 min on to two 9 cm Petri dishes containing 10 mL tryptic soy broth (TSB). A 0.1 mL aliquot, as well as the same volume of 1:10 and 1:100 dilutions, were seeded in TSB. Sampling fluids were spread over tryptic soy agar dishes with a sterile glass spatula. Two dishes were used for each dilution. No more than 5 min elapsed between sampling and seeding. Dishes were incubated for 24 h at 37 ! 2 # C. After an initial count of the cfu, Petri dishes were incubated for another 24 h to detect slow-growing colonies.5 Surgical preparation phase Each volunteer used the test products at least on a weekly basis, in order to allow reconstitution of participants’ skin flora. All products were used according to the manufacturers’ instructions. After surgical hygiene, hands were rinsed with running tap water for 15 s and dried with a sterile cotton towel. 65 Determination of post values After hand preparation, one hand was randomly selected to obtain the post-value (immediate effect). The other hand was allowed to dry and thereafter gloved (sterile surgical glove) for 3 h for assessment of the sustained effect, obtained after removal of the glove. In order to obtain the post-value, TSB with neutralizers was used. The neutralizers were 3% Tween80, 3% saponin, 0.1% histidine and 0.1% cysteine. Sampling was done in a similar way to the immediate effect. Moreover, participants were asked to report eventual personal notation about the effects of the different products on their skin (such as: dusty, sticky sensations). Data analysis For each dilution the mean number of cfu scored in duplicate dishes was calculated. This was multiplied by the dilution factor in order to obtain the number of cfu per millilitre of sampling liquid. Pre- and post-values were expressed as log10 values. For calculation purposes values of 0 were reset to 1, whereas values uncountable in the Petri dish were considered as 1,000,000 cfu (with log10 ¼ 6). If countable values of cfu were obtained from more than one dilution their mean was used to calculate the final logarithm value. For each volunteer the reduction factor (RF) was obtained as the difference between log10 post-values and the log10 pre-value. The mean of the log10 values (RF) of each product were compared with the corresponding values for a paired analysis of the immediate and sustained effect. Paired t-test was used to compare immediate and sustained effect globally for each product. Difference between mean RFs of different products was performed with analysis of variance (ANOVA) with Bonferroni correction for multiple comparisons; a post-hoc analysis was performed with Tukey’s honestly significant difference (HSD) test. All analysis were two-tailed, with level of significance set at P < 0.05. Analyses were performed by using Stata 9.0 software (Stata Corp., College Station, TX, USA). Results Alcohol-based product had an immediate mean RF significantly higher than the other agents (Figure 1); in particular, the alcohol formulation showed a mean 2.27 ! 1.64 log10 reduction, followed by chlorhexidine, with 0.94 ! 1.11 log10 reduction, and povidone-iodine 0.16 ! 0.42. Comparison of mean RFs using an ANOVA model revealed a significant difference between the products (F ¼ 17.03; P < 0.0001). In order to clarify the results, we report pair-wise comparisons between each couple of tested products (Table I). The post-hoc analysis revealed that the alcohol-based product was significantly more effective compared with the other tested products (P < 0.0001; Tukey’s HSD). After 3 h (Figure 2) the situation was similar to that registered immediately. In particular, after 3 h the alcohol formulation showed a mean 1.91 ! 1.52 log10 reduction, followed by chlorhexidine, with 0.82 ! 1.16 log10 reduction, and povidone iodine 0.52 ! 0.92. ANOVA tests showed a significant difference between sustained effects for all the products (F ¼ 7.12; P < 0.01); details for pairwise comparisons of product are reported in Table II. The post hoc analysis revealed that the alcohol-based product was significantly more effective compared with the other tested products (P < 0.0001; Tukey’s HSD). 66 -6 -6 -4 -4 Reduction factor 0 -2 Reduction factor -2 0 2 2 P. Barbadoro et al. / Journal of Hospital Infection 86 (2014) 64e67 Alcohol Chlorhexidine Povidone-iodine Alcohol Chlorhexidine Povidone-iodine Figure 1. Box plot showing immediate effect (reduction factor with respect to plain soap) of different agents. Figure 2. Box plot showing sustained effect (reduction factor with respect to plain soap after 3 h) of different agents. On the hands of 35% (7/20) of volunteers, small sticky agglomerates appeared, presumably formed by the reaction between flaking skin cells and the glycerol of the alcohol hand rub while performing hand hygiene with alcohol-based hand rub. We have defined this phenomenon as ‘skin peeling’. In participants experiencing this phenomenon, the RF for the sustained effect was significantly lower than that registered for the immediate effect (1.06 ! 0.47 log10 vs 2.48 ! 1.24 log10 with respect to the group who did not show this phenomenon, P < 0.05). This difference was not significant in participants who did not experience the skin peeling (with immediate RF of 2.16 ! 1.82 log10 vs 2.37 ! 1.71 log10 of RF for sustained effect, P > 0.05). Our main finding is that significant differences under practical conditions were observed in vivo for products currently used in surgical hand preparation. The best results were achieved with the alcohol-based hand rub. This is not surprising as their efficacy in the preoperative treatment of hands is well known; nevertheless many professionals involved in surgical procedures remain reluctant to switch from an antiseptic soap to an alcohol-based hand rub.12 Moreover, Tanner et al. have concluded that the quality of the sum of the evidence regarding alcohol hand rub use for surgical hand preparation is variable and that the effects on the outcome, when considering surgical site infections, is mixed.1 The excellent immediate effect may also be enhanced by the presence of excipients, that have been shown to be important.9 However, we also note the paradoxical effect shown in vivo in volunteers with self-reported skin peeling, resulting in a higher number of cfu measured at 48 h compared with volunteers without skin peeling. In our opinion, such hand rubs may cause the formation of small agglomerates in selected users which feel like ‘gritty’ particles on the hands (skin peeling). This effect has already been described in association with the use of powdered gloves, but in this trial this effect was not related to use of powdered gloves, since it was noted after hand disinfection and before glove use.3 This finding may suggest that the substantially reduced effect of alcohol-based hand rub, in selected participants, may be associated with the glycerol content of the gel, as has been recently reported, and may also be responsible for the ‘gritty’ particles noted by some participants.11 We agree with Suchomel et al., who discuss the possible role of glycerol in producing a moister environment under surgical gloves, thus supporting the multiplication of residual skin flora and drawing bacterial flora from deeper skin layers. In accordance with the Guideline for Hand Hygiene in Health-Care Settings, we may suggest switching to an alternative product, or using hand washing after disinfection with alcohol products for these professionals.3,11 Further studies are needed to investigate the interactions between skin flora and the glycerol content of the alcohol hand rub. Moreover, we must underline that a modified version of the above hand rub has been adopted in other countries, but is not licensed in Italy, where only the above-tested product is available. In conclusion, our experience confirms the importance of alcohol-based hand rubs for the surgical decontamination of hands. Moreover, our results highlight the value of assessing the characteristics, and response of healthcare workers’ skin, that may contribute to the development of clumps which may contribute to a paradoxical overcolonization 3 h after surgical Table I Difference between reduction factor, pairwise comparison of product for immediate effect Table II Difference between reduction factor, pairwise comparison of product for sustained effect Discussion Alcohol Chlorhexidine Povidone-iodine a 1.33 2.11a P < 0.05 (analysis of variance). Chlorhexidine a 0.78a Alcohol Chlorhexidine Povidone-iodine a 1.09 1.39a P < 0.05 (analysis of variance). Chlorhexidine a 0.30a P. Barbadoro et al. / Journal of Hospital Infection 86 (2014) 64e67 hand decontamination with alcohol-based hand rubs containing glycerol. These results underline the need to obtain a more powerful, yet tolerable, hand solution in order to overcome barriers to utilization, side-effects, and to improve hand hygiene behaviour. Conflict of interest statement None declared. Funding sources None. References 1. Tanner J, Swarbrook S, Stuart J. Surgical hand antisepsis to reduce surgical site infection. Cochrane Database Syst Rev 2008;(1):CD004288. 2. Dudeck MA, Horan TC, Peterson KD, et al. National Healthcare Safety Network (NHSN) Report, data summary for 2010, deviceassociated module. Am J Infect Control 2011;39:798e816. 3. Boyce JM, Pittet D, Healthcare Infection Control Practices Advisory Committee, et al. Guideline for Hand Hygiene in Health-Care Settings: recommendations of the Healthcare Infection Control Practices Advisory Committee and the HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force. Infect Control Hosp Epidemiol 2002;23:S3eS40. 4. Pittet D, Allegranzi B, Boyce J, World Health Organization World Alliance for Patient Safety First Global Patient Safety Challenge Core Group of Experts. The World Health Organization Guidelines on Hand Hygiene in Health Care and their consensus recommendations. Infect Control Hosp Epidemiol 2009;30:611e622. 67 5. European Norm (EN) 12054. Chemical disinfectants and antiseptics. Quantitative suspension test for the evaluation of bactericidal activity of products for hygienic and surgical hand rub and hand wash used in human medicine. Test method and requirements (Phase 2/Step 1). Brussels: Comitè Europeen de Normalisation; 2001. 6. European Norm (EN) 12791. Chemical disinfectants and antiseptics e surgical hand disinfection. Test method and requirements (Phase 2/Step 2). Brussels: Comitè Europeen de Normalisation; 2005. 7. Labadie J-C, Kampf G, Lejeune B, et al. Recommendation for surgical hand disinfection requirements, implementation and need for research. A proposal by representatives of the SFHH, DGHM and DGKH for a European discussion. J Hosp Infect 2002;51: 312e315. 8. Suchomel M, Kundi M, Allegranzi B, Pittet D, Rotter ML. Testing of the World Health Organization-recommended formulations for surgical hand preparation and proposals for increased efficacy. J Hosp Infect 2011;79:115e118. 9. Edmonds SL, Macinga DR, Mays-Suko P, et al. Comparative efficacy of commercially available alcohol-based hand rubs and World Health Organization-recommended hand rubs: formulation matters. Am J Infect Control 2012;40:521e525. 10. Kampf G, Ostermeyer C. WHO-recommended hand-rub formulations do not meet European efficacy requirements for surgical hand disinfection in 5 minutes. J Hosp Infect 2011;78:123e127. 11. Suchomel M, Rotter M, Weinlich M, Kundi M. Glycerol significantly decreases the three hour efficacy of alcohol-based surgical hand rubs. J Hosp Infect 2013;83:284e287. 12. Rotter ML. Arguments for alcoholic hand disinfection. J Hosp Infect 2001;48(Suppl. A):S4eS8. A systemAtic review of surgicAl hAnd Antisepsis utilizing An Alcohol prepArAtion compAred to trAditionAl products Artigo de revisão Revisão sistemática sobre antissepsia cirúrgica das mãos com preparação alcoólica em comparação aos produtos tradicionais* revisión sistemáticA sobre AntisepsiA quirúrgicA de mAnos con prepArAción AlcohólicA compArAdA A productos trAdicionAles Karen de Jesus Gonçalves1, Kazuko Uchikawa Graziano2, Julia Yaeko Kawagoe3 RESUmo AbStRAct RESUmEn A antissepsia cirúrgica das mãos visa à prevenção de infecções do sítio cirúrgico, importante causa de morbimortalidade pós-operatória e aumento dos custos hospitalares. Este estudo teve como objetivo comparar a eficácia de preparações alcoólicas com os produtos tradicionais na antissepsia cirúrgica das mãos por meio de uma revisão sistemática da literatura. Foram considerados estudos primários ou secundários, tendo como desfecho a contagem microbiana das mãos ou taxas de infecções do sítio cirúrgico. A busca foi realizada no Portal BVS, PubMed, Ask e MEDLINE. Foram selecionados 25 estudos (2 revisões sistemáticas, 19 experimentais e 4 de coorte). As preparações alcoólicas tiveram uma redução microbiana igual e/ou maior aos produtos tradicionais em 17 estudos e inferior em 4; as taxas de infecções do sítio cirúrgico foram similares. Portanto, existem evidências científicas que suportam a segurança das preparações alcoólicas para antissepsia cirúrgica das mãos. Surgical hand antisepsis aims at preventing surgical site infections, an important cause of postoperative morbidity and mortality and escalating hospital costs. The objectives of this study were to compare the efficacy of alcohol preparations with traditional surgical hand antisepsis products by means of a systematic review of the literature. Primary and secondary studies were included, considering the microbial count or surgical site infection rates as outcomes. The search was performed on the BVS Portal, PubMed, Ask and MEDLINE. Twentyfive studies were selected (two systematic reviews, nineteen experimental and four cohort studies). The alcohol preparations promoted a microbial reduction equal to and/or greater than traditional products in 17 studies, and a lesser reduction in four studies; similar surgical site infection rates were identified. Therefore, there is scientific evidence that support the safety of alcohol preparations for surgical hand antisepsis. La antisepsia quirúrgica de manos apunta a prevenir infecciones en el sitio quirúrgico, causa importante de morbi-mortalidad postoperatoria y aumento de costos hospitalarios. El estudio objetivó comparar la eficacia de preparaciones alcohólicas con los productos tradicionales de la antisepsia quirúrgica de manos, mediante revisión sistemática de la literatura. Fueron considerados estudios primarios o secundarios, teniendo como objetivo el recuento microbiano en manos o tasas de infecciones del sitio quirúrgico. La búsqueda fue realizada en las bases BVS, PubMed, Ask y MEDLINE. Fueron seleccionados 25 estudios (2 revisiones sistemáticas, 19 experimentales y 4 de cohorte). Las preparaciones alcohólicas consiguieron una reducción microbiana igual y/o mayor que los productos tradicionales en 17 estudios, e inferior en 4; las tasas de infección del sitio quirúrgico fueron equivalentes. Por lo tanto, existen evidencias científicas que dan soporte a la seguridad de las preparaciones alcohólicas para la antisepsia quirúrgica de las manos. dEScRitoRES dEScRiPtoRS dEScRiPtoRES Antissepsia Cirurgia geral Lavagem de mãos Controle de infecções Enfermagem de Centro Cirúrgico Antisepsis General surgery Handwashing Infection control Operating Room Nursing Antisepsia Cirugía general Lavado de manos Control de infecciones Enfermería de quirófano * extraído do trabalho de conclusão de curso “revisão sistemática sobre antissepsia cirúrgica das mãos com preparação alcoólica em comparação aos produtos tradicionais”, escola de enfermagem da universidade de são paulo, 2010. 1 enfermeira pela escola de enfermagem da universidade de são paulo. são paulo, sp, brasil. [email protected] 2 enfermeira. professora titular do departamento de enfermagem médico-cirúrgica da escola de enfermagem da universidade de são paulo. são paulo, sp, brasil. [email protected] 3 enfermeira epidemiologista do serviço de controle de infecção do hospital israelita Albert einstein. são paulo, sp, brasil. [email protected] 1484 Rev Esc Enferm USP 2012; 46(6):1484-93 www.ee.usp.br/reeusp/ recebido: 09/05/2011 Aprovado: 09/12/2011 Revisão sistemática sobre antissepsia cirúrgica das mãos com português / inglês preparação alcoólica em comparação aoswww.scielo.br/reeusp produtos tradicionais Gonçalves KJ, Graziano KU, Kawagoe JY A systemAtic review of surgicAl hAnd Antisepsis utilizing An Alcohol prepArAtion compAred to trAditionAl products Artigo de revisão Revisão sistemática sobre antissepsia cirúrgica das mãos com preparação alcoólica em comparação aos produtos tradicionais* revisión sistemáticA sobre AntisepsiA quirúrgicA de mAnos con prepArAción AlcohólicA compArAdA A productos trAdicionAles Karen de Jesus Gonçalves1, Kazuko Uchikawa Graziano2, Julia Yaeko Kawagoe3 RESUmo AbStRAct RESUmEn A antissepsia cirúrgica das mãos visa à prevenção de infecções do sítio cirúrgico, importante causa de morbimortalidade pós-operatória e aumento dos custos hospitalares. Este estudo teve como objetivo comparar a eficácia de preparações alcoólicas com os produtos tradicionais na antissepsia cirúrgica das mãos por meio de uma revisão sistemática da literatura. Foram considerados estudos primários ou secundários, tendo como desfecho a contagem microbiana das mãos ou taxas de infecções do sítio cirúrgico. A busca foi realizada no Portal BVS, PubMed, Ask e MEDLINE. Foram selecionados 25 estudos (2 revisões sistemáticas, 19 experimentais e 4 de coorte). As preparações alcoólicas tiveram uma redução microbiana igual e/ou maior aos produtos tradicionais em 17 estudos e inferior em 4; as taxas de infecções do sítio cirúrgico foram similares. Portanto, existem evidências científicas que suportam a segurança das preparações alcoólicas para antissepsia cirúrgica das mãos. Surgical hand antisepsis aims at preventing surgical site infections, an important cause of postoperative morbidity and mortality and escalating hospital costs. The objectives of this study were to compare the efficacy of alcohol preparations with traditional surgical hand antisepsis products by means of a systematic review of the literature. Primary and secondary studies were included, considering the microbial count or surgical site infection rates as outcomes. The search was performed on the BVS Portal, PubMed, Ask and MEDLINE. Twentyfive studies were selected (two systematic reviews, nineteen experimental and four cohort studies). The alcohol preparations promoted a microbial reduction equal to and/or greater than traditional products in 17 studies, and a lesser reduction in four studies; similar surgical site infection rates were identified. Therefore, there is scientific evidence that support the safety of alcohol preparations for surgical hand antisepsis. La antisepsia quirúrgica de manos apunta a prevenir infecciones en el sitio quirúrgico, causa importante de morbi-mortalidad postoperatoria y aumento de costos hospitalarios. El estudio objetivó comparar la eficacia de preparaciones alcohólicas con los productos tradicionales de la antisepsia quirúrgica de manos, mediante revisión sistemática de la literatura. Fueron considerados estudios primarios o secundarios, teniendo como objetivo el recuento microbiano en manos o tasas de infecciones del sitio quirúrgico. La búsqueda fue realizada en las bases BVS, PubMed, Ask y MEDLINE. Fueron seleccionados 25 estudios (2 revisiones sistemáticas, 19 experimentales y 4 de cohorte). Las preparaciones alcohólicas consiguieron una reducción microbiana igual y/o mayor que los productos tradicionales en 17 estudios, e inferior en 4; las tasas de infección del sitio quirúrgico fueron equivalentes. Por lo tanto, existen evidencias científicas que dan soporte a la seguridad de las preparaciones alcohólicas para la antisepsia quirúrgica de las manos. dEScRitoRES dEScRiPtoRS dEScRiPtoRES Antissepsia Cirurgia geral Lavagem de mãos Controle de infecções Enfermagem de Centro Cirúrgico Antisepsis General surgery Handwashing Infection control Operating Room Nursing Antisepsia Cirugía general Lavado de manos Control de infecciones Enfermería de quirófano * extraído do trabalho de conclusão de curso “revisão sistemática sobre antissepsia cirúrgica das mãos com preparação alcoólica em comparação aos produtos tradicionais”, escola de enfermagem da universidade de são paulo, 2010. 1 enfermeira pela escola de enfermagem da universidade de são paulo. são paulo, sp, brasil. [email protected] 2 enfermeira. professora titular do departamento de enfermagem médico-cirúrgica da escola de enfermagem da universidade de são paulo. são paulo, sp, brasil. [email protected] 3 enfermeira epidemiologista do serviço de controle de infecção do hospital israelita Albert einstein. são paulo, sp, brasil. [email protected] 1484 Rev Esc Enferm USP 2012; 46(6):1484-93 www.ee.usp.br/reeusp/ recebido: 09/05/2011 Aprovado: 09/12/2011 Revisão sistemática sobre antissepsia cirúrgica das mãos com português / inglês preparação alcoólica em comparação aoswww.scielo.br/reeusp produtos tradicionais Gonçalves KJ, Graziano KU, Kawagoe JY intRodUção As infecções do sítio cirúrgico (ISC) são a maior causa de morbi-mortalidade pós-operatória e representam grandes gastos para os hospitais(1). Apesar da causa multifatorial, estudos têm correlacionado as ISC, por meio de biologia molecular, às falhas na antissepsia cirúrgica das mãos da equipe cirúrgica, causando inclusive surtos(2-4). A paramentação cirúrgica, medida bem estabelecida para prevenção das infecções do sítio cirúrgico, consiste em antissepsia cirúrgica das mãos, utilização de aventais e luvas esterilizadas, além de gorro e máscara(5). Apesar do uso de luvas cirúrgicas, a transmissão de micro-organismos das mãos da equipe cirúrgica para o paciente pode ocorrer, considerando que ao final da cirurgia cerca de 18% (5 a 82%) das luvas cirúrgicas apresentam micro-perfurações, sendo que em mais de 80% dos casos essas perfurações não são percebidas pelos cirurgiões(6), e podem dobrar o risco de infecções do sítio cirúrgico(7), tornando esse preparo prévio das mãos essencial. dade antimicrobiana (valor basal), imediatamente após a antissepsia (efeito imediato) e após 3hs com mãos enluvadas (efeito residual). As amostras são colhidas por fricção das pontas dos dedos em placas com meio de cultura e neutralizantes, uma para cada mão. Os valores são expressos em unidades formadoras de colônias (UFC)/mL e transformados em logaritmos decimais e não podem ser significativamente inferiores aos obtidos com o produto referência (PR). Para o produto ser classificado com efeito residual, os resultados obtidos após 3 horas devem ser significativamente maiores que os obtidos pelo produto referência. Também existem, na Europa, outras normas para determinação do espectro antimicrobiano dos antissépticos em testes in-vitro, que precedem os in-vivo. Nos Estados Unidos, vigora o método da American Society for Testing and Methods (ASTM E1115)(17), com testes in-vitro que medem o espectro antimicrobiano contra uma quantidade específica de diferentes micro-organismos e testes in-vivo. Nos testes in-vivo os produtos são utilizados por 5 dias consecutivos, sendo aplicados uma vez nos dias 1º e 5º, e 3 vezes nos dias 2º, 3º e 4º. O antisséptico cirúrgico deve ser capaz O número de participantes é definido a partir de eliminar totalmente a microbiota transio diferencial do álcool de uma fórmula, e antes do início do estudo tória das mãos e reduzir significativamente são colhidas amostras dos valores basais. As a residente no começo do procedimento, e em relação aos outros amostras microbianas são colhidas imediataantissépticos é sua mente após a antissepsia (efeito imediato) e inibir o seu crescimento em mãos enluvadas rápida velocidade até o final da cirurgia(8-13). Os antissépticos após 3 e 6 horas com mãos enluvadas (efeito mais utilizados atualmente são a clorexidide ação, além de residual), nos dias 1º, 2º e 5º (efeito cumuna (CHG) e o polivinilpirrolidona iodo (PVPI) excelente atividade lativo). Utiliza-se o método glove juice para aplicados com esponja e/ou escova, apesar antimicrobiana contra coleta das amostras onde as mãos são aleada Organização Mundial da Saúde (OMS) toriamente divididas nos tempos 1 minuto, 3 bactérias gramnão recomendar o uso de escovas para essa horas e 6 horas após a aplicação. Os valores positivas, gramfinalidade pelo seu efeito abrasivo(14). obtidos expressos em UFC/mão são transfornegativas, fungos, mados em log10. O produto testado deve atinAs preparações alcoólicas (PA) têm sido micobactérias e vírus. gir os seguintes resultados: no dia 1º deve (14) recomendadas pela OMS , nas concentrahaver uma redução bacteriana de 1 log após ções entre 60 e 80%, e pelo Centers for Disea1 minuto de aplicação, e após 6 horas não dese Control and Prevention (CDC) dos Estados ve exceder o valor basal; ao final do dia 2º deve haver uma Unidos(13), nas concentrações entre 60 e 95%, como produredução de 2 log após 1 minuto de aplicação; e ao final do to de escolha na higienização das mãos e como alternativa dia 5º uma redução de 3 log após 1 minuto de aplicação. aos produtos tradicionais (PT) para antissepsia cirúrgica das mãos, justificada pela eficácia antimicrobiana, facilidade de Apesar desses movimentos na Europa e nos Estados aplicação, menor dano à pele e economia de tempo(13-14). O Unidos e das recomendações da OMS e do CDC, o uso do diferencial do álcool em relação aos outros antissépticos é álcool para antissepsia cirúrgica das mãos no Brasil, até sua rápida velocidade de ação, além de excelente ativida- hoje não é uma prática difundida. Muitos acreditam que de antimicrobiana contra bactérias Gram-positivas, Gram- a escovação vigorosa das mãos e antebraços é essencial -negativas, fungos, micobactérias e vírus(8,13). para o preparo da pele(15), além do método tradicional ser considerado um ritual preparatório para a cirurgia(18) e um Há cerca de 30 anos as preparações alcoólicas (PA) são momento de concentração da equipe cirúrgica. A prática usadas na Europa para antissepsia cirúrgica das mãos(15). baseada em evidências (PBE) pode ser um dos passos paNos países deste continente, vigora a EN 12791 da Comi- ra vencer essa resistência ao uso do álcool, desde que se té Européen de Normalisation (CEN)(16) como método de prove a eficácia desses produtos. avaliação da eficácia de antissépticos destinados à antissepsia cirúrgica das mãos. Nele, a eficácia antimicrobiana Esse estudo teve como questão norteadora: É segura a dos produtos é testada em 20 voluntários sadios e adota- substituição da técnica tradicional de antissepsia cirúrgica -se como produto referência (PR) o n-propanol 60% v/v, das mãos e antebraços da equipe cirúrgica por aplicação aplicado por 3 minutos. As amostras microbianas são de preparações à base de álcool? e tem como relevância colhidas após lavagem das mãos com sabonete sem ativi- subsidiar mudanças dessa prática no cenário nacional. Revisão sistemática sobre antissepsia cirúrgica das mãos com preparação alcoólica em comparação aos produtos tradicionais Gonçalves KJ, Graziano KU, Kawagoe JY Rev Esc Enferm USP 2012; 46(6):1484-93 www.ee.usp.br/reeusp/ 1485 obJEtiVo Comparar a eficácia antimicrobiana de preparações alcoólicas com os produtos tradicionais na antissepsia cirúrgica das mãos, evidenciada pela literatura científica por meio de uma revisão sistemática. mÉtodo A PBE, definida pelo Evidence Based Medicine Work Group (Canadá) como o processo de sistematicamente descobrir, avaliar e usar achados de investigações como base para decisões clínicas(19), tem a revisão sistemática como um recurso importante, na qual as informações relacionadas a um determinado problema são coletadas, categorizadas, avaliadas e sintetizadas(20). O presente estudo trata-se de uma revisão sistemática da literatura tendo como base as pesquisas básicas e revisões sistemáticas, de modo a responder à pergunta da pesquisa. A busca dos dados ocorreu entre os meses de junho e setembro de 2010. Os estudos foram obtidos a partir de acessos de domínio público: Portal BVS (Centro Latino-Americano e do Caribe de Informação em Ciências da Saúde, também conhecido pelo seu nome original Biblioteca Regional de Medicina), que inclui busca nas bases e portais LILACS (Literatura Latino-Americana e do Caribe em Ciências da Saúde), IBECS (Índice Bibliográfico Español en Ciencias de la Salud), MEDLINE (National Library of Medicine/NLM), The Cochrane Library e SciELO (Scientific Eletronic Library Online); PubMed (National Library of Medicine/NLM); e Ask MEDLINE. Também foi realizada busca de referências cruzadas das publicações obtidas a partir das bases de dados com o objetivo de encontrar outros estudos não localizados com a busca eletrônica. Os descritores da saúde utilizados na busca, com auxílio de conectores booleanos, foram: antissepsia or lavagem de mãos and salas cirúrgicas or centros de cirurgia or cirurgia and etanol or 1-propanol or 2-propanol or feniletil álcool and povidona-iodo or clorexidina. A busca em bases de língua inglesa foi realizada com os seguintes Medical Subject Heading (MeSH) termos: surgical hand disinfection OR surgical hand antisepsis OR surgical hand rub OR surgical hand rubbing OR surgical hand scrub OR surgical hand scrubbing AND alcohol hand rubs OR alcohol-based hand rub OR alcohol OR n-propanol OR 1-propanol OR 2-propanol OR isopropanol OR ethanol AND chlorhexidine OR povidone iodine. No Ask Medline foi formulada a seguinte questão: Could alcohol replace traditional surgical hand antisepsis? Os critérios de inclusão dos estudos foram: estudos primários ou secundários, que abordaram a eficácia da antissepsia cirúrgica das mãos com preparações alcoólicas em comparação aos produtos e técnicas tradicionais com CHG ou PVPI; em campo ou em laboratório; com voluntários ou profissionais da saúde; apresentando como desfecho a redução da contagem microbiana das mãos ou taxas 1486 Rev Esc Enferm USP 2012; 46(6):1484-93 www.ee.usp.br/reeusp/ de infecções do sítio cirúrgico; nos idiomas inglês, português ou espanhol; sem restrição à data de publicação. Os critérios de exclusão foram: artigos de reflexão, revisões de literatura narrativa; higienização simples das mãos com álcool; artigos que não compararam a eficácia das preparações alcoólicas com produtos tradicionais; artigos que utilizaram produtos tradicionais anteriormente à aplicação da preparação à base de álcool; artigos em que o álcool não era o principal ingrediente ativo da preparação alcoólica. Os estudos foram analisados por três pesquisadores, sendo dois deles especialistas no assunto e nos métodos de investigação. A análise e seleção dos estudos foram realizadas em três fases. Na primeira, realizada por um único investigador, os estudos foram analisados e pré-selecionados segundo os critérios de inclusão e exclusão por meio de seus resumos, e quando estes não estavam disponíveis, através do artigo completo. Após essa pré-seleção, os estudos foram analisados com instrumento de coleta de dados baseado no modelo de Mendonça(21), incluindo: tipo de investigação, objetivos, amostra, método, desfechos, resultados e conclusão. A terceira fase incluiu a avaliação dos estudos pelos três investigadores de forma independente, com ampliação da coleta de dados, com maior especificação em relação aos objetivos dessa revisão sistemática, chegando aos estudos selecionados para a pesquisa. Foram realizadas reuniões para discussão e consenso entre os pesquisadores acerca dos estudos, e sua inclusão ou exclusão. Os estudos foram classificados quanto sua validade interna e nível de evidência seguindo o modelo proposto pela U.S. Preventive Services Task Force (USPSTF/Task Force) (22) , em cinco níveis de evidência: I – pelo menos um estudo clínico controlado randomizado bem conduzido; II-1 – estudos clínicos controlados sem randomização bem conduzidos; II-2 – estudos de coorte ou caso-controle bem conduzidos; II-3 – múltiplos estudos longitudinais com ou sem intervenção; e III – opiniões de autoridades respeitadas, baseadas na experiência clínica, estudos descritivos e relatos de caso, ou relatos de comitês de especialistas. Cada nível é subdividido em três categorias, bom, moderado e ruim, de acordo com critérios de validade interna definidos para cada tipo de estudo, incluindo revisões sistemáticas. RESULtAdoS E diScUSSão Por meio da busca eletrônica realizada foram localizados 132 artigos e com a análise de suas referências obteve-se mais 25, totalizando 157 artigos. Desse total, 26 estudos foram excluídos por repetição e 79 por não atenderem aos critérios de inclusão dessa pesquisa, sendo pré-selecionados 52 artigos. Não entraram na pesquisa 17 artigos que não foram obtidos textos completos. Após análise dos textos na íntegra e reuniões de consenso, 10 artigos foram excluídos por não atenderem aos critérios da pesquisa. Com isso, 25 estudos foram selecionados, identificados por ordem cronológica como E1 a E23, R1 e R2, estes últimos referentes a duas revisões sistemáticas. Revisão sistemática sobre antissepsia cirúrgica das mãos com preparação alcoólica em comparação aos produtos tradicionais Gonçalves KJ, Graziano KU, Kawagoe JY O Quadro 1 apresenta os estudos selecionados com seus respectivos autores, país de origem, ano de publicação, título e fonte de publicação. No Quadro 2 há um resumo dos artigos em relação ao tipo de investigação, nível de evidência, método utilizado, técnica de obtenção da amostra microbiana, tempo de obtenção da amostra, preparações alcoólicas e produtos tradicionais utilizados e os principais resultados. Quadro 1 - Estudos selecionados sobre antissepsia cirúrgica das mãos com antisséptico à base de álcool em substituição aos produtos tradicionais. Estudo Autor(es) País Ano Fonte de Publicação Título E1 Lowbury EJ, Lilly HA. Reino Unido 1960 Disinfection of the hands of surgeons and nurses Br Med J E2 Lowbury EJ, Lilly HA, Bull JP. Reino Unido 1964 Methods for disinfection of hands and operation sites Br Med J E3 Lowburry EJL, Lilly HA, Ayliffe GAJ. Reino Unido 1974 Preoperative disinfection of surgeons’ hands: use of alcoholic solutions and effects of gloves on skin flora Br Med J E4 Jarvis JD, Wynne CD, Enwright L, Williams JD. Reino Unido 1979 Handwashing and antiseptic-containing soaps in hospital E5 Larson EL, Butz AM, Gullette DL, Laughon BA. Estados Unidos 1990 Alcohol for surgical scrubbing? Infect Control Hosp Epidemiol E6 Hobson DW, Woller W, Anderson L, Guthery E. Estados Unidos 1998 Development and evaluation of new alcohol-based surgical and scrub formulation with persistent antimicrobial characteristics and brushless application Am J Infect Control E7 Pietsch H. Alemanha 2001 Hand antiseptics: rubs versus scrubs, alcoholic solutions versus alcoholic gels E8 Mulberry G, Snyder AT, Heilman J, Pyrek J, Stahl J. Estados Unidos 2001 Evaluation of a waterless, scrubless chlorexidine gluconate/ethanol surgical scrub for antimicrobial efficacy Am J Infect Control E9 Larson, Aiello, Heilman, Lyle, Cronquist, Stahl, Della-Latta. Estados Unidos 2001 Comparison of different regimens for surgical hand preparation AORN E10 Bryce EA, Spence D, Roberts FJ. Canadá 2001 An in-use evaluation of an alcohol-based pre-surgical hand disinfectant Infect Control Hosp Epidemiol E11 Sigler M, Bastyr J, Stahl J, Pyrek J. Estados Unidos 2001 Comparison of a waterless, scrubless CHG/ethanol surgical scrub to traditional CHG and povidone-iodine surgical scrubs 3M Health Care. E12 Parienti JJ; Thibon P; Heller R; Le Roux Y; von Theobald P; Bensadoun H; Bouvet A; Lemarchand F; Le Coutour X. França 2002 Hand-rubbing with an aqueous alcoholic solution vs traditional surgical hand-scrubbing and 30-day surgical site infections rates – a randomized equivalence study JAMA E13 Marchetti MG, Kampf G, Finzi G, Salvatorelli G. Itália, Alemanha 2003 Evaluation of the bactericidal effect of five products for surgical hand disinfection according to prEN 12054 and prEN 12791 J Hosp Infect E14 Berman M. Estados Unidos 2004 One hospital’s clinical evaluation of brushless scrubbing. AORN J E15 Rotter M, Kundi M, Suchomel M, Harke H-P, Kramer A, Ostermeyer C, Rudolph P, Sonntag H-G, Werner H-P. Alemanha, Áustria 2006 Reproducibility and workability of the European Test Standard EN 12791 regarding the effectiveness of surgical hand antiseptics: a randomized, multicenter trial Infect Control Hosp Epidemiol E16 Hajipour L, Longstaff L, Cleeve V, Brewster N, Bint D, Henman P. Reino Unido 2006 Hand washing rituals in trauma theatre: clean or dirty? Ann R Coll Surg Engl E17 Palmer JS. Estados Unidos 2006 Use of Avagard in pediatric urologic procedures Estados Unidos 2007 Comparison of two alcohol-based surgical scrub solutions with an iodine-based scrub brush for presurgical antiseptic effectiveness in a community hospital J Hosp Infect França 2007 An in-use microbiological comparison of two surgical hand disinfection techniques in cardiothoracic surgery: hand rubbing versus hand scrubbing J Hosp Infect Estados Unidos 2007 Influence of rings on the efficacy of hand sanitization and residual bacterial contamination J Clin Pathol J Hosp Infect Urology E18 Gupta C; Czubatyj AM; Briski LE; Malani AK. E19 Carro C, Camilleri L, Traore O, Badrikian L, Legaula B, Azarnoush K, Dualé C, De Riberolles C. E20 Wongworawat MD, Jones SG. E21 Marchand R, Theoret S, Dion D, Pellerin M. Canadá 2008 Clinical implementation of a scrubless chlorhexidine/ ethanol pre-operative surgical hand rub E22 Kac G, Masmejean E, Gueneret M, Rodi A, Peyrard S, Podglajen I. França 2009 Bactericidal efficacy of a 1.5 min surgical hand-rubbing protocol under in-use conditions E23 Weight CJ; Lee MC; Palmer JS. Estados Unidos 2010 Avagard hand antisepsis vs. Traditional scrub in 3600 pediatric urologic procedures. Urology Taiwan 2006 Surgical hand scrubs in relation to microbial counts: systematic literature review. J Adv Nurs Reino Unido 2008 Surgical hand antisepsis to reduce surgical site infection. R1 Hsieh HF, Chiu HH, Lee FP. R2 Tanner J, Swarbrook S, Stuart J. Revisão sistemática sobre antissepsia cirúrgica das mãos com preparação alcoólica em comparação aos produtos tradicionais Gonçalves KJ, Graziano KU, Kawagoe JY Infect Control Hosp Epidemiol Can Oper Room Nurs J J Hosp Infect Cochrane Database Syst Rev Rev Esc Enferm USP 2012; 46(6):1484-93 www.ee.usp.br/reeusp/ 1487 1488 Rev Esc Enferm USP 2012; 46(6):1484-93 www.ee.usp.br/reeusp/ Revisão sistemática sobre antissepsia cirúrgica das mãos com preparação alcoólica em comparação aos produtos tradicionais Gonçalves KJ, Graziano KU, Kawagoe JY Nível I Moderado EClRL Nível II-1 – Ruim EClL A: Nível II-1 – Moderado B: Nível II-1 – Ruim C: Nível II-1 – Ruim EClL A: Nível I – Moderado B: Nível II-1 – Ruim EClRL A: Nível II-1 – Moderado B: Nível II-1 – Ruim 60 pessoas (12 por grupo) 6 pessoas A: 6 pessoas B: não cita C: não cita A: 6 pessoas B: 8 pessoas para CHG ou álcool+CHG e 2 para laurolínio 5 pessoas (A) e 20 luvas (B) Amostra/ Perdas ou Exclusões Lavagem das mãos com solução Ringer Técnica de obtenção da amostra microbiana Fricção da ponta dos dedos com mão enluvada [previamente perfurada nas pontas] após lavagem com sabonete comum (A) e caldo da luva utilizada (B) Outro Outro Glove juice Antes, imediatamente e 4hs Álcool etílico 70% + após a antissepsia CHG 0,5% 6x5mL. nos dias 1º e 5º. Antes, imediatamente Álcool 95% + CHG Lavagem das após e após 90 0,5% por 2 min mãos com após 1ª e 6ª solução Ringer min antissepsia (3x/ (2x10mL). dia por 2 dias). Álcool 95% + CHG 0,5% > PVPI alcoólico > PVPI > CHG > sabonete com PVPI > sabonete simples em barra Obs.: resultado com base nos valores absolutos. A: álcool etílico 70% + CHG 0,5% = acetato de laurolínio 5% + álcool etílico 70% = acetato de laurolínio 5% aquoso > PVPI = laurolínio spray > controle. B: CHG 0,5% + álcool 70% = CHG 0,5% em todos os tempos de aplicação. Soluções de CHG > laurolínio com 30 e 120 min de aplicação. continua... Triclosan 1%, CHG 4%, Betadine®2, Álcool etílico 70% + CHG 0,5% > Betadine®2 > sabonete sem atividade antimicrobiana, CHG 4% > triclosan 1% = sabonete sem atividade todos por 2x5mL (5 min). antimicrobiana PVPI, CHG e PVPI alcoólico por 2 min (2x10mL), sabonete simples em barra e sabonete em barra com PVPI por 2 min A: álcool etílico 95% + CHG 0,5% = álcool etílico 95,3% + tetrabromo metil fenol 0,1% > álcool etílico 95% = CHG 4% > CHG 0,5% > controle Álcool etílico 95% + CHG 0,5% > CHG 4% A: CHG 0,5% aquoso, CHG 4%; Álcool etílico 95,3% + tetrabromo metil fenol 0,1% ambos por 2 min (2x5mL), sabonete = CHG 4% em barra e água por 2 min. B: álcool isopropílico 70% + CHG 0,5% > CHG 4% > álcool isopropílico 70% > álcool etílico 70% B: CHG 0,5% aquoso, PVPI + CHG 0,5% > álcool etílico 70% > PVPI > CHG (Disadine®), clorexilenol 2,5% aquoso, 0,5% > cloroxilenol 2,5% > sabonete sem atividade CHG 4% detergente, sabonete em antimicrobiana. barra sem atividade antimicrobiana; CHG 4% com melhor efeito residual, álcool etílico todos por 2 min. 70%, álcool isopropílico 70% e PVPI com os menores efeitos residuais. Obs.: resultado com base nos valores absolutos. C: Irgasan 2% DP 300® detergente, C: álcool etílico 95% + CHG 0,5% > álcool etílico 95,3% sabonete. + tetrabromo metil fenol 0,1% > Irgasan DP 300 2% > sabonete em barra. Álcool etílico 70% sem efeito residual. Obs.: resultado com base nos valores absolutos. A: álcool etílico 95% + CHG 0,5%, álcool etílico 95,3% + tetrabromo metil fenol 0,1%, álcool etílico 95%; todos por 2 min (2x5mL). B: álcool etílico 70% + CHG 0,5%, álcool isopropílico70% + CHG 0,5%, álcool isopropílico 70%, álcool etílico 70%; todos por 2 min. C: álcool etílico 95% + CHG 0,5%, álcool etílico 95,3% + tetrabromo metil fenol 0,1%, álcool etílico 70%. Antes e após antissepsia A: PVPI, acetato de laurolinio 5% aquoso, laurolínio 5% spray por 2 min. Controle: lavagem rápida sobre água. B: CHG 0,5% aquoso, laurolínio 5% aquoso por por 30, 60, 90 e 120 seg. Obs.: resultado com base nos valores absolutos. Neomicina e bacitracina > Phisohex® > álcool 70% + CHG 0,5% > álcool 70% > hexaclorofeno 2% > swab com álcool > sabonete Resultados A: álcool etílico 70% + CHG 0,5%, acetato de laurolinio 5% + álcool etílico 70% por 2 min B: álcool 70% + CHG 0,5%, laurolínio 5% + álcool 70% por 30, 60, 90 e 120 seg. Produto tradicional Lavagem simples (rápida) com água e sabonete (A). Sabonete em barra por 5 min. Sabonete em barra por 5 min seguido de uso de luvas com pó de 5mg de sulfato de neomicina e 5mg de bacitracina por grama de pó (A). Hexaclorofeno sabonete em todas as higienizações das mãos e banhos durante a semana antes do experimento, e por 5 min para o experimento (A). Phisohex® em todas as higienizações das mãos e banhos durante a semana antes do experimento, e por 2 min para o experimento (A). Produto a base de álcool Sabonete em barra por 5 min seguido da aplicação de álcool 70% por volume por 3 min Sabonete em barra Após 1 e 3h com (A). 5 min seguido da mãos enluvadas por de álcool 70% (A) e ao final da aplicação contendo CHG 0,5% por cirurgia (B) 3 min (A). Sabonete em barra por 5 min, seguido de uma rápida fricção com swab molhado com álcool (A e B). Tempo de obtenção da amostra A: antes, imediatamente após antissepsia a 1ª e 6ª aplicação (3x/dia A: Outro por 2 dias). B: Outro (uso Lavagem das B: antes, de luvas) mãos com imediatamente C: Outro (efeito solução Ringer após e após 3hs residual) da antissepsia C: 3h após antissepsia (com contaminação prévia) Outro Outro [avalia microorganismos que saem por perfurações nas luvas (A) e os deixados no interior da luva após uso (B). Método e=estudo; revs= revisão sistemática; cl=clínico; co= coorte; r=randomizado; ce= cego; pce=parcialmente cego; re = retrospectivo; cc=no ambiente da unidade do centro cirúrgico; cA=no ambiente de cirurgias Ambulatoriais; l=laboratorial. * E5 E4 E3 E2 E1 EClL (A) e CC (B) Tipo de InvestiEstudo gação*/Nível de Evidência Quadro 2 - Métodos e resultados da eficácia antimicrobiana de antissépticos para antissepsia cirúrgica das mãos a base de álcool e tradicionais. Revisão sistemática sobre antissepsia cirúrgica das mãos com preparação alcoólica em comparação aos produtos tradicionais Gonçalves KJ, Graziano KU, Kawagoe JY Rev Esc Enferm USP 2012; 46(6):1484-93 www.ee.usp.br/reeusp/ 1489 Outro ASTM prEN12054 e prEN12791 Outro 27 pessoas da equipe cirúrgica/2 25 pessoas da equipe cirúrgica (em cirurgias <2h) e 16 (em cirurgias >3h) 124 pessoas (41 no grupo do Hibiclens® e PA e 42 no grupo do Betadine®2) 4823 pacientes/ 436 20 pessoas para prEN 12791 75 pacientes e todos os membros da equipe cirúrgica que quiseram participar/ vários pacientes, 4 profissionais EClRCC Nível I Moderado EClCC Nível II-1 – Moderado EClRpCeL Nível I Moderado EClRCC Nível I – Bom EClRL Nível I – Moderado ECoReCC Nível II-2 – Ruim E9 E10 E11 E12 E13 E14 Outro ASTM Taxa de infecção do sítio cirúrgico Fricção das pontas dos dedos Taxa de infecção do sítio cirúrgico Glove juice Sterillium® 2x5mL (total de 5 min). - Álcool etílico 70% + piritionato de zinco 3 min. Sterillium®, Softa Man®, n-propanol Antes, 1min e 3h 60% por 5 min no após. teste in-vitro e 3 min (3mL quantas vezes necessário) no in-vivo. (em 30 dias) Antes, 1 min, 3h Álcool etílico 61% + e 6h após nos dias 1º, 2º e 5º. CHG 1% 2x3mL. Não cita. ® Derman Plus , Hibiscrub , Betadine por 5 min no teste in-vitro e 3 min (3mL) no in-vivo. ® Betadine®1 ou Hibiscrub® por 5 min. Hibiclens® por 6 min (2x5mL), Betadine®2 por 10 min (2x5mL). CHG 4% ou PVPI 7,5% por 3 min. CHG 4% por 6 min. Antes e imediatamente após nos dias 1º e 5º da primeira semana e no último dia da 3º semana. Álcool etílico 61% + CHG 1% 3x2mL. Hibiclens® 2x5mL (2x3 min). Antes, 1 min, 3h Avagard® 3x2mL, e 6h após nos álcool etílico 61% dias 1º, 2º e 5º. 3x2mL. ®2 Hibiscrub® (não cita tempo). Sterillium® (não cita tempo). Antes, imediatamente após e ao final da cirurgia. Produto tradicional Betadine®2 por 10 min ou Hibiclens® por 6 min. Produto a base de álcool Antes, 1 min, 3h e 6h após nos Triseptin® por 3 min. dias 1º, 2º e 5º. Tempo de obtenção da amostra Fricção das Antes, pontas dos imediatamente Manorapid® por 3 min dedos e glove após e ao final da (3x5mL). juice cirurgia. Glove juice Glove juice Glove juice Glove juice Técnica de obtenção da amostra microbiana continua... Álcool etílico 70% + piritionato de zinco = produto tradicional prEn12054: Sterillium®, Softa Man®, Derman Plus®, Hibiscrub®, Betadine® = atendem aos critérios prEN12791: n-propanol 60% = Hibiscrub® e Softa Man® n-propanol 60% > Betadine® e Derman Plus® Sterillium® > n-propanol 60% Sterillium® = Betadine® ou Hibiscrub® Álcool etílico 61% + CHG 1% > Hibiclens® e Betadine®2 Efeito cumulativo álcool etílico 61% + CHG 1% > Betadine®2 e = Hibiclens® Obs.: Betadine só atingiu os critérios ASTM após 1 min no dia 1º, Hibiclens atendeu somente nos dias 1º e 5º, álcool etílico 61% + CHG 1% atendeu todos os critérios Cirurgias < 2h: Manorapid® = PVPI 7,5% ou CHG 4% Cirurgias > 3 h: Manorapid® > PVPI 7,5% ou CHG 4% Álcool etílico 61% + CHG 1% = CHG 4% Efeito residual do CHG 4% > álcool etílico 61% + CHG 1% Avagard® > Hibiclens® > álcool etílico 61% Álcool etílico 61% não atingiu os critérios ASTM para os dias 2º e 5º. Efeito imediato: Sterillium® > Hibiscrub® Efeito residual: Sterillium® = Hibiscrub® Dia 1º e 2º: Triseptin® > Betadine®2 e Hibiclens® Dia 5º: Triseptin® = Hibiclens® > Betadine®2 Betadine®2 sem efeito cumulativo. Triseptin® aplicado com escova = esponja = somente c/ as mãos Resultados e=estudo; revs= revisão sistemática; cl=clínico; co= coorte; r=randomizado; ce= cego; pce=parcialmente cego; re = retrospectivo; cc=no ambiente da unidade do centro cirúrgico; cA=no ambiente de cirurgias Ambulatoriais; l=laboratorial. * Outro A:52 pessoas B:85 pessoas EClRCeL Nível I Moderado E8 Outro 75 cirurgiões EClRCC Nível I Moderado E7 ASTM E6 Método 90 pessoas (18 por grupo) Amostra/ Perdas ou Exclusões EClRL Nível II-1 – Moderado Tipo de InvestiEstudo gação*/Nível de Evidência ...continuação 1490 Rev Esc Enferm USP 2012; 46(6):1484-93 www.ee.usp.br/reeusp/ Revisão sistemática sobre antissepsia cirúrgica das mãos com preparação alcoólica em comparação aos produtos tradicionais Gonçalves KJ, Graziano KU, Kawagoe JY Taxa de infecção do sítio cirúrgico 18 membros da equipe cirúrgica/2 54 pacientes 18 profissionais da equipe cirúrgica Outro (compara 60 pessoas contagem (membros de microbiana após equipe cirúrgica) antissepsia com e sem uso de anel) 2084 cirurgias para PT, 2175 cirurgias para PA, todos os membros da equipe cirúrgica EClRpCeCC Nível I – Moderado EClCC Nível II-1 – Moderado EClRpCeL Nível I – Moderado ECoReCC Nível II-2 – Moderado E18 E19 E20 E21 - Imediatamente após. Antes, 1 min e 6h após nos dias 1º, 2º e 5º Antes, imediatamente após, após 2h, 4h e ao final da cirurgia. - Álcool etílico 70% + CHG 0,5%. Triseptin®, Avagard®. Sterillium® 2x6mL + 3mL nas trocas de luvas. Avagard® 3x 2mL, Triseptin® por 3 min. Avagard® 2x3mL (2 min). 10 estudos [1 analisando infecção do sítio cirúrgico com preparação alcoólica e tradicional (E12), 6 comparando preparação alcoólica com produto tradicional (E7, E12, E16, E18, Estudo não selecionado para esta pesquisa por usar CHX antes da preparação à base de álcoola, Estudo não encontrado pelas autorasb)] a. Pereira LJ, Lee GM, Wade KJ. An evaluation of five protocols for surgical handwashing in relation to skin condition and microbial counts. Journal of Hospital Infection 1997; Vol. 36:49-65. b. Herruzo Cabrera R, Vizcaino Alcaide MJ, Fdez Acinero MJ. Usefulness of an alcohol solution of NDuopropenide for the surgical antisepsis of the hands compared with handwashing with iodine povidone and chlorhexidine. Journal of Surgical Research 2000; Vol. 94:6-12. RevS (ECRCC) Bom R2 Avagard® = escova impregnada com produto tradicional 3 estudos [2 comparando preparação alcoólica com produto tradicional (E9 e E10)] Escova impregnada com produto tradicional (6 min). RevS (ECRCC) Moderado Avagard® 2x3mL (2 min). R1 - Outro 3600 pacientes (1800 em cada grupo) 1 cirurgião ECoReCC Nível II-2 – Ruim E23 Taxa de infecção do sítio cirúrgico Outro Aplicação por 3 min: Sterillium® > Betadine®1 Sterillium® por 3min = Sterillium® por 1,5 min Álcool etílico 70% + CHG 0,5% = produto tradicional Avagard® com anel = Avagard® sem anel Triseptin com anel = Triseptin® sem anel BD E-Z Scrub 205 com anel > BD E-Z Scrub 205® sem anel. Com e sem anel: Avagard® > Triseptin® = BD E-Z Scrub 205® Sterillium® = Hibiscrub® = Betadine®1 Avagard® e Triseptin® = PVPI Somente Avagard® apresentou efeito cumulativo. Avagard® = escova impregnada com produto tradicional CHG > Álcool 70% + CHG 0,5% (gel) 1-propanol 60% > álcool etílico 85% > 2-propanol 70% > CHG 4%. Resultados 19 cirurgiões, 25 cirurgias cada produto Betadine®1 por 3 min. Não cita. BD E-Z Scrub 205®. Hibiscrub®, Betadine®1 por 3 min. PVPI 7,5% por 6 a 10 min. Escova impregnada com produto tradicional (2 a 5 min). CHG por 5 min em todas as 1ªs antissepsias, e por 3 min nas demais. CHG 4% por 3min. Produto tradicional EClpCeCA Nível II-1 – Moderado Fricção das Antes, 1min Sterillium® por 3 min pontas dos após e ao final da (10,5mL) e 1,5 min dedos e da cirurgia. (6mL). palma da mão Fricção das pontas dos dedos Glove juice Taxa de infecção do sítio cirúrgico Álcool 70% + CHG 0,5% (gel) por 3 min. 2-propanol 70% v/v, álcool etílico 85% v/v, 1-propanol 60% v/v por 3 min. Produto a base de álcool E22 Outro Outro ASTM Outro Ao final da cirurgia. Antes, 1min após. Tempo de obtenção da amostra triseptin®: álcool etílico 70% + piritionato de zinco Sterillium®: 2-propanol 45% + 1-propanol 30% + mecetrônio etilsulfato 0,2% Avagard®: álcool etílico 61% + chg 1% manorapid®: isopropanol 70% + butanodiol 0,1% + lanolina 0,06% Softa man®: álcool etílico 45% + 1-propanol 18% Phisohex®: hexaclorofeno 3% com creme + detergente aniônico disadine®: não cita formulação irgasan 2% dP 300®: não cita formulação betadine®1: pvpi 4% betadine®2: pvpi 7,5% Hibiclens®: chg 4% Hibiscrub®: chg 4% derman Plus®: triclosan 1% bd E-Z Scrub 205®: 1% pvpi disponível e=estudo; revs= revisão sistemática; cl=clínico; co= coorte; r=randomizado; ce= cego; pce=parcialmente cego; re = retrospectivo; cc=no ambiente da unidade do centro cirúrgico; cA=no ambiente de cirurgias Ambulatoriais; l=laboratorial. * Glove juice 1100 pacientes (550 por grupo) 1 cirurgião ECoReCC Nível II-2 – Ruim Fricção das pontas dos dedos E17 Outro 41 cirurgias e 82 antissepsias das mãos/2 antissepsias EClRpCeCC Nível I – Ruim Fricção das pontas dos dedos E16 EN12791 Técnica de obtenção da amostra microbiana 20 pessoas em cada um dos 5 laboratórios Método EClRL Nível I – Moderado Amostra/ Perdas ou Exclusões E15 Tipo de InvestiEstudo gação*/Nível de Evidência ...continuação No Brasil, não há até o momento estudos publicados sobre esse tema nas fontes investigadas. A própria utilização do álcool para higienização simples das mãos, medida eficaz e conhecida, tem sofrido resistência por parte dos profissionais no país. orgânica (no caso foram utilizados sangue de carneiro e contaminação artificial das mãos com S. macescens ATCC 14756)(23). A OMS recomenda o uso de palito de unha, mas não recomenda o uso de escova para as unhas, devido seu caráter abrasivo(14). O emprego de metodologias oficiais, publicadas por organizações reconhecidas, para avaliar a eficácia de antissépticos para o preparo cirúrgico das mãos foi fundamental na realização da presente revisão sistemática. Testes padronizados e oficiais além de permitirem comparação entre resultados proporcionam maior confiabilidade aos mesmos. Dos 25 trabalhos analisados, seis (24%) utilizaram metodologias oficiais, sendo quatro da ASTM (E6, E8, E11, E18) e dois da prEN 12791 ou EN 12791 (E13, E15, respectivamente). O tempo de aplicação/contato dos produtos tradicionais foi entre 2 a 10 minutos. Já para as preparações alcoólicas, o tempo variou de 1,5 a 5 minutos e na descrição da aplicação do produto, muitos deram ênfase ao tempo de aplicação/ contato em detrimento da quantidade, que pode variar com o tamanho da superfície de aplicação. Em apenas um estudo (E2) houve testes com tempos menores, como 30 segundos. Os dois estudos de revisão sistemática (8,0% - R1 e R2) localizados, apesar de não serem exclusivos para antissepsia cirúrgica das mãos com preparações alcoólicas em comparação com produtos tradicionais, avaliaram estudos randomizados controlados realizados em campo com a mesma finalidade desta pesquisa. A contagem microbiana ou sua redução foram os desfechos analisados pela maioria dos estudos selecionados (78,3%). Doze estudos (60,0%) analisaram o efeito imediato e residual dos produtos (E3B, E4, E5, E6, E7, E8, E10, E11, E13, E18, E19, E22), cinco (25,0%) apenas o efeito imediato (E2, E3A, E9, E15, E20), três estudos (15,0%) somente o efeito residual (E1, E3C, E16), oito (40,0%) o efeito cumulativo (E3A, E4, E5, E6, E8, E9, E11, E18) e quatro (20,0%) não colheram amostras antes da antissepsia para fins comparativos (E1, E3C, E16, E20). Cinco estudos (21,7% - E12, E14, E17, E21, E23) utilizaram como desfecho a taxa de infecções do sítio cirúrgico. Os métodos de coleta das amostras microbianas variaram, sendo os principais o “glove juice” e a impressão/ contato das pontas dos dedos em meio de cultura. Os estudos mais antigos utilizaram a lavagem das mãos com solução Ringer e a cultura de alíquotas dessa solução. Ainda sobre a técnica utilizada, 14 estudos relataram algum preparo das mãos antes da utilização do produto (60,9%), sendo que em oito estudos (34,8% - E5, E6, E8, E10, E11, E14, E18, E19) os espaços subungueais foram limpos antes do procedimento de antissepsia cirúrgica, com escovação ou uso de palito de unha. A necessidade ou não de escovação ou uso de palito no espaço subungueal para sua limpeza antes da utilização da preparação alcoólica, no parecer das autoras, ainda é uma lacuna existente sobre o tema pelo seu caráter abrasivo à pele. Nos estudos selecionados não fica claro qual o impacto desse procedimento sobre a redução da microbiota da pele após a antissepsia química. Sabe-se que esta é uma região que acumula sujidade e consequentemente micro-organismos(13), contudo um estudo realizado com uma modificação da metodologia oficial européia, a EN 1500, mostra que o álcool nas formulações gel e líquida tem ação microbicida na pele mesmo na presença de matéria Revisão sistemática sobre antissepsia cirúrgica das mãos com preparação alcoólica em comparação aos produtos tradicionais Gonçalves KJ, Graziano KU, Kawagoe JY As preparações alcoólicas apresentam menor tempo de aplicação/contato em relação aos produtos tradicionais, devido seu rápido efeito antimicrobiano o que otimiza o tempo dos profissionais e os recursos hospitalares (E1)(15), aspecto que pode ser muito útil entre cirurgias rápidas (oftalmológicas, por exemplo) que são realizadas subsequentemente pela equipe cirúrgica. Em alguns países - onde a prática da utilização de preparação alcoólica na antissepsia cirúrgica das mãos já é aceita -, existem estudos que têm avaliado a redução do tempo de contato com esses produtos, porém não foram incluídos por não atenderem aos critérios de inclusão dessa pesquisa. Apesar da aceitação europeia de preparação alcoólica na antissepsia cirúrgica das mãos, pesquisa realizada no Reino Unido (2007) mostrou que o método tradicional ainda é o mais utilizado (representando 90% na primeira antissepsia do dia) e a preparação alcoólica é utilizada repetidamente em apenas 20% dos casos(24). As preparações alcoólicas apresentam como vantagem a economia de água e custos. Devido seu método de aplicação — apenas fricção sobre a pele, não necessita de enxágue, consequentemente dispensa o controle rigoroso da qualidade da água, como utilização de filtros, não usa toalha/compressa esterilizada. Estudos como o (E9), mostram que as preparações alcoólicas promovem uma redução dos custos por procedimento em até 67% em relação aos produtos tradicionais(25). Sob o ponto de vista ecológico, há economia considerável de água, além de dispensar a estrutura de lavabo na unidade de centro cirúrgico. Estudo realizado no Reino Unido, contabilizou a quantidade de água utilizada para a antissepsia cirúrgica das mãos com CHG ou PVPI, chegando a 18,5 L por procedimento e 931,938 L de água gastos por ano(26). A principal desvantagem do álcool é seu efeito ressecante sobre a pele, que pode ser contornado com a adição de emolientes, umectantes ou outros condicionantes à formulação(8,15). Estudos que avaliaram o efeito da preparação alcoólica e dos produtos tradicionais sobre a pele mostraram que as preparações alcoólicas, com a adição de emolientes, ou não em alguns estudos (E8), apresentam de maneira geral, um efeito melhor ou similar à pele em comparação aos produtos tradicionais (E7, E8, E9, E10, E12, E18, E19). Por esse motivo e devido ao método de aplicação, houve uma meRev Esc Enferm USP 2012; 46(6):1484-93 www.ee.usp.br/reeusp/ 1491 lhor aceitação pelos profissionais (E9, E12, E18, E19). Ainda sobre as características negativas do álcool, alguns estudos reportaram o cheiro forte e, em alguns casos, sensação de queimação/ardência nas mãos (E18), que pode ocorrer se aplicado em soluções de continuidade da pele(8). Já os produtos tradicionais, na maioria dos casos, pioraram os aspectos da pele e em alguns casos houve efeitos adversos (E7, E8, E9, E12, E18, E19). Outras desvantagens das preparações alcoólicas são sua natureza volátil, precisando de atenção especial para o recipiente e local de armazenamento; necessidade de secar completamente após aplicação; e por não ter ação surfactante, há a necessidade de lavar as mãos com água e sabonete quando estas estiverem visivelmente sujas (E18). Finalmente, com relação à eficácia antimicrobiana, 90,5% dos estudos relataram que as preparações alcoólicas tiveram redução microbiana maior (17 estudos — E1, E2A, E3A, E3B, E3C, E4, E5, E6, E7, E8, E9, E10 para cirurgias maiores de 3hs, E11, E13, E15, E18, E22) ou igual (seis estudos — E2B, E3A, E10 para cirurgias menores de 2hs, E13, E19, E20) aos produtos tradicionais, sendo que em quatro destes, o resultado variou entre maior ou igual dependendo do produto tradicional e/ou da preparação alcoólica (E2A, E2B, E3A, E13). Quatro estudos 19,0% — (E1, E3B, E8, E16) mostraram a ineficácia do álcool quando comparado ao produto tradicional, porém no (E1) o produto tradicional, é o hexaclorofeno, atualmente proibido no Brasil devido seu efeito tóxico; o (E3B) não apresenta análise estatística (somente valores absolutos); no (E8) o álcool etílico 61% como único princípio ativo foi inferior ao CHG 4%, já o álcool etílico 61% com CHG 1% foi melhor; e o (E16) não utilizou neutralizante no meio de cultura, caracterizando um importante viés do estudo. O álcool isoladamente não apresenta efeito residual, apesar disso, a recuperação da microbiota da pele ocorre lentamente, pela contínua morte dos microorganismos e provavelmente devido ao efeito sub-letal em algumas bactérias da pele(8,14-15). Contudo, a adição de outros antissépticos de ação sinérgica em pequenas concentrações — como compostos de quaternário de amônio, hexaclorofeno ou clorexidina — às preparações alcoólicas confere ao álcool efeito residual, e foram utilizados na maioria dos estudos analisados. Todos os estudos que tiveram como medida de desfecho as taxas de ISC (E12, E14, E17,E21,E23) apresentaram resultados que comprovam que não há diferença estatisticamente significante entre as preparações alcoólicas e os produtos tradicionais utilizados. A eficácia antimicrobiana de preparação alcoólica na antissepsia cirúrgica das mãos depende do tipo de álcool utilizado, da concentração e do tempo de contato. Nesse sentido, para utilização em território nacional, é importante a elaboração de normas e teste de validação da eficácia antimicrobiana desses produtos e que estes sejam registrados pela ANVISA, já que atualmente não existe uma regulamentação nacional para preparação alcoólica com essa finalidade. Devemos ampliar as atuais discus- 1492 Rev Esc Enferm USP 2012; 46(6):1484-93 www.ee.usp.br/reeusp/ sões sobre higienização das mãos com preparação alcoólica (como a obrigatoriedade da disposição de preparação alcoólica para fricção antisséptica das mãos nos serviços de Saúde do Brasil(27)) na antissepsia cirúrgica das mãos. Em alguns estudos (E6, E11, E18) que adotaram a metodologia ASTM, as preparações tradicionais não atingiram todos os critérios (níveis de redução microbiana) exigidos pelo método, o que gera um questionamento sobre a eficácia desses produtos já amplamente utilizados e aceitos ou sobre os padrões de redução microbiana exigidos por essa metodologia. Em relação à qualidade dos estudos, das revisões sistemáticas (6,9%), a R1 foi classificada como moderado devido ao pequeno número de estudos e por não apresentar as formulações alcoólicas utilizadas nos estudos, e a R2 como bom. Doze estudos foram classificados como Nível I (41,4%), variando quanto à validade interna, onde um estudo foi classificado como categoria bom (E12); 10 como categoria moderado (E2A, E5, E7, E8, E9, E11, E13, E15, E18, E20); e um como categoria ruim (E16) por não utilizar neutralizante na amostra. Onze estudos foram classificados como Nível II-1 (37,9%), sendo seis da categoria moderado (E1A, E3A, E6, E10, E19, E22) e cinco ruins (E1B, E2B, E3B, E3C, E4) por não apresentarem análise estatística. Nesse tipo de experimento, para testar produtos com naturezas de aplicação diferentes (somente fricção para o álcool ou técnica tradicional com produto que contém detergente para os PT) é muito difícil conduzir investigações duplo-cegas, justificando poucos estudos na categoria bom nos Níveis I e II-1, além de somente um estudo (E12) ter realizado análise intent-to-treat. Os demais estudos (quatro - 13,8%) foram classificados como Nível II-2, sendo um da categoria moderado (E21) e três categorias ruins (E14, E17, E23) por não considerarem as variáveis envolvidas na ISC. concLUSão Esta revisão sistemática permitiu concluir que há evidências científicas sobre a segurança do uso de preparação alcoólica (PA) para a antissepsia cirúrgica das mãos, podendo, portanto, substituir a técnica tradicional com CHG ou PVPI contendo detergente, ressaltando que a eficácia do álcool depende de seu tipo, concentração e tempo de contato. Os resultados obtidos vão ao encontro das atuais recomendações da OMS e do CDC, além de obter os mesmos resultados de outros estudos já realizados, como as duas revisões sistemáticas incluídas nessa pesquisa. Para que uma mudança ocorra na prática, é necessária a divulgação de novas pesquisas, oferecendo informações sobre os benefícios com base em evidências científicas. 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Available from: http://www.fda.gov/ohrms/dockets/ac/05/ briefing/2005-4098B1_02_03-FDA-TAB1.pdf 13. Boyce JM, Pittet D; Healthcare Infection Control Practices Advisory Committee. Guideline for Hand Hygiene in Health-Care Settings. Recommendations of the Healthcare Infection Control Practices Advisory Committee and the HICPAC/ SHEA/APIC/IDSA Hand Hygiene Task Force. MMWR Recomm Rep. 2002;51(RR-16):1-45. Revisão sistemática sobre antissepsia cirúrgica das mãos com correspondência: Kazuko uchikawa graziano preparação alcoólica em comparação aos – produtos tradicionais Av. dr. enéas de carvalho Aguiar, 419 cerqueira césar Gonçalves KJ, Graziano KU, Kawagoe JY brasil cep 05403-000 - são paulo, sp, 16. European Standards. CSN EN 12791. Chemical disinfectants and antiseptics - Surgical hand disinfection - Test method and requirements (phase2/step2). Brussels; 2005. 17. International Standards Worldwide. ASTM E 1115 - 11. Standard Test Method for Evaluation of Surgical Hand Scrub Formulations [Internet]. West Conshohocken; 2011 [cited 2011 May 26]. Available from: http://enterprise.astm.org/ filtrexx40.cgi?+REDLINE_PAGES/E1115.htm 18. Greer RB 3rd. The ritual at the scrub sink. Orthop Rev. 1994;23(2):97. 19. Evidence-Based Working Group. Evidence-based medicine: a new approach to teaching the practice of medicine. JAMA. 1992;268(17):2420-5. 20. Galvão CM, Sawada NO, Trevizan MA. Revisão sistemática: recurso que proporciona a incorporação das evidências na prática da enfermagem. Rev Latino Am Enferm. 2004;12(3):549-56. 21. Mendonça SHF. Impacto do uso de conectores sem agulha para sistema fechado de infusão na ocorrência de infecção de corrente sanguínea relacionada ao cateter venoso central: evidências de uma Revisão Sistemática [dissertação]. São Paulo: Escola de Enfermagem, Universidade de São Paulo; 2008. 22. Harris RP, Helfand M, Woolf SH, Lohr KN, Mulrow CD, Teutsch SM, et al.; Methods Work Group, Third US Preventive Services Task Force. Current methods of the US Preventive Services Task Force: a review of the process. Am J Prev Med. 2001;20(3 Suppl):21-35. 23. Kawagoe JY, Graziano KU, Martino MDV, Siqueira I, Correa L. Bacterial reduction of alcohol-based liquid and gel products on hands soiled with blood. Am J Infect Control. 2011;39(9):785-7. 24. Tanner J, Blunsden C, Fakis A. National survey of hand antisepsis practices. J Perioper Pract. 2007;17(1):27-37. 25. Tavolacci MP, Pitrou I, Merle V, Haghighat S, Thillard D, Czernichow P. Surgical hand rubbing compared with surgical hand scrubbing: comparison of efficacy and costs. J Hosp Infect. 2006;63(1):55-9. 26. Jehle K, Jarrett N, Matthews S. Clean and green: saving water in the operating theatre. Ann R Coll Surg Engl. 2008;90(1):22-4. 27. Brasil. Ministério da Saúde; Agência Nacional de Vigilância Sanitária. Resolução n. 42, de 25 de outubro de 2010. Dispõe sobre obrigatoriedade de disponibilização de preparação alcoólica para fricção antisséptica das mãos, pelos serviços de saúde do País, e dá outras providências. Diário Oficial da União, Brasília, 26 out. 2010. Seção 1, p. 27. Rev Esc Enferm USP 2012; 46(6):1484-93 www.ee.usp.br/reeusp/ 1493 Journal of Microbiology, Immunology and Infection (2015) 48, 322e328 Available online at www.sciencedirect.com ScienceDirect journal homepage: www.e-jmii.com ORIGINAL ARTICLE Comparative antimicrobial efficacy of alcohol-based hand rub and conventional surgical scrub in a medical center Ni-Jiin Shen a, Sung-Ching Pan a,b, Wang-Huei Sheng a,b,*, Kwei-Lian Tien b, Mei-Ling Chen b, Shan-Chwen Chang b,c, Yee-Chun Chen a,b,c a Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan Center for Infection Control, National Taiwan University Hospital, Taipei, Taiwan c Department of Medicine, National Taiwan University, College of Medicine, Taipei, Taiwan b Received 29 April 2013; received in revised form 30 July 2013; accepted 13 August 2013 Available online 21 September 2013 KEYWORDS Alcohol-based hand rub; Surgical antisepsis; Surgical site infection Background: Hand hygiene is the cornerstone of aseptic techniques to reduce surgical site infection. Conventional surgical scrub is effective for disinfecting a surgeon’s hands. However, the compliance of conventional scrub may be hindered by skin damage, allergy, and time. Alcohol-based hand rub has a satisfactory antimicrobial effect, but mostly in laboratory settings. Our aim was to compare a conventional surgical scrub with an alcohol-based hand rub to evaluate antimicrobial efficacy. Methods: From June 1, 2010 to July 31, 2011, 128 healthcare workers were enrolled in the study. They used an alcohol-based hand rub or a conventional surgical scrub as preoperative hand antisepsis during their routine practice. Hand sampling for cultures were performed before and after operations. Positive culture plates were further processed for pathogen identification. Results: The culture positive rate of the alcohol-based hand rub was 6.2% before operations and 10.8% after operations. Both rates were lower than the conventional surgical scrub [47.6% before operations (p < 0.001) and 25.4% after operations (p Z 0.03)]. The most identified pathogens were Gram-positive with coagulase-negative staphylococci being the major pathogen. Multivariate analysis showed that prior hand condition (p Z 0.21) and type of surgery such as cardiovascular surgery (p Z 0.12) were less relevant, but the alcohol-based hand rub was a significant protective factor for positive hand cultures. * Corresponding author. Department of Internal Medicine, National Taiwan University Hospital, Number 7, Chung-Shan South Road, Taipei 100, Taiwan. E-mail address: [email protected] (W.-H. Sheng). 1684-1182/$36 Copyright ª 2013, Taiwan Society of Microbiology. Published by Elsevier Taiwan LLC. All rights reserved. http://dx.doi.org/10.1016/j.jmii.2013.08.005 Efficacy of alcohol-based hand rub 323 Conclusion: The alcohol-based hand rub was more efficacious for surgical antisepsis and had sustained efficacy, compared to conventional surgical scrub. We suggest that alcohol-based hand rubs could be an alternative surgical antiseptic in the operative theater. Copyright ª 2013, Taiwan Society of Microbiology. Published by Elsevier Taiwan LLC. All rights reserved. Introduction Surgical site infection is a globally recognized problem that results in significant morbidity.1 Joseph Lister was among the first to demonstrate the effect of skin disinfection on reducing surgical site infections.2 Thus, washing hands with antimicrobial soaps, warm water, and frequently with a brush became the primary protocol for surgical hand preparation. Antiseptic soaps should rapidly eliminate transient skin flora and reduce resident flora on the hands to a minimum during a surgical procedure, and thus lower the risk of surgical site contamination if surgical gloves are perforated or torn during surgery.3 Conventional surgical hand antisepsis consists of an aqueous scrub with a brush by using povidone iodine (PVP-I) or chlorhexidine-based detergents. However, scrubbing with these detergents strips skin oils, compromises skin integrity, and (if a brush is used) often causes microabrasions, thereby increasing the risk of subsequent colonization by pathogens.4 As a result, conventional surgical scrub has the disadvantages of skin damage and allergic skin reaction. It is also time consuming to use them. In the laboratory setting, an alcohol-based hand rub is as effective as conventional surgical scrub in its antimicrobial ability.5,6 In addition, skin irritation or dermatitis happened less frequently with an alcohol-based hand rub in a small series of case studies. This can also help increase the compliance of hand washing by healthcare providers in hospitals.7e9 Several alcohol-based hand rubs have been licensed for the commercial market, although there are few clinical studies to compare the antisepsis efficacy against conventional surgical scrub in a routine operating practice environment.10,11 The World Health Organization (WHO) guidelines also state that surgical antisepsis is a state of art, suggesting that there are no optimal antiseptics.12 We conducted a prospective, observational study in our hospital with the aim of comparing a conventional surgical scrub with an alcohol-based hand rub to evaluate their antisepsis efficacy before and after operations. Materials and methods Hospital setting The National Taiwan University Hospital (NTUH) is a medical center with 2388 beds. It comprises three operation theaters with 52 functioning operating rooms (including five delivery rooms). More than 140 surgical procedures were performed daily during 2010 and 2011. The entrance of each operating room is equipped with a sensor sink or a step-operated sink that contains two sets of antisepsis scrubbing facilities. The study was approved by the surgical committee and by the institutional review board of the National Taiwan University Hospital (NTUH-IRB; No. 201109015RC). Inclusion criteria This prospective observational study was conducted from June 1, 2010 to July 31, 2011. The volunteer participants were practicing doctors and nurses who had previous experience with the conventional surgical scrub protocol in the operating environment. They were allocated to the intervention group (i.e., alcohol-based hand rub) or the control group (i.e., conventional surgical scrub), based on their choice (rather than by randomization). All participants were educated and rehearsed in the alcohol-based hand rub protocol prior to this study. The participants’ characteristics such as having an allergy to conventional surgical scrub or having wounds on their hands and the characteristics of the surgeries such as surgical specialty, surgical site, surgical wound classification, type of surgery, blood loss amount, operation duration, and glove wearing duration were recorded. Exclusion criteria Participants were excluded if they did not complete providing samples for culture before the operation (T0) and after the operation (T1). Participants with missing baseline characteristics data were also excluded. Hand preparation and sampling The alcohol-based hand rub contained 1% chlorhexidine gluconate and 61% ethyl alcohol (Avagard; 3M, MN, USA). The standard hand rub protocol was as follows: (1) one pump (2 mL) of lotion was dispensed into the palm of the left hand; (2) the fingertips of the right hand were dipped into the lotion to decontaminate under the nails; (3) the remaining lotion was spread over the right hand and up to just above the elbow; and (4) a second pump (2 mL) of lotion was then placed into the palm of the right hand. This process was repeated by dipping the fingers tip of the left hand into the lotion, followed by spreading it over the left hand and up to just below the elbow. Another 2 mL of lotion was finally placed into cupped hands and reapplied to all aspects of the hands up to the wrists. This solution was then allowed to dry. The three-step application of the alcoholbased hand rub (Avagard) was completed within 2 minutes. The conventional surgical scrub contained 4% chlorhexidine gluconate (Hibiscrub; Janson’s Medical Co., Taipei, 324 N.-J. Shen et al. Taiwan) or 7.5% povidone-iodine. The standard conventional surgical scrub protocol was as follows: (1) three full squirts (6 mL) of PVP-I or chlorhexidine were placed into the cupped hands; (2) this was followed by a five-minute hand scrubbing just up to the elbow by using a sterile scrub brush; and (3) the lotion was rinsed away by tap water. All aforementioned steps were repeated, except the hands were dried with sterile towels, instead of being rinsed with tap water, to avoid recontamination. After hand scrubbing or rubbing protocol, every participant was sampled immediately before the operation (T0). They then performed the scheduled operations. Another sample was obtained after the operation (T1). We used normal saline-moistened sterile cotton swabs to obtain Table 1 specimens for cultures by wiping through every part of the hand (including the ventral and dorsal side of the hands), the fingertips, and the lateral sides of the fingers and the wrists. The samples were immediately inoculated onto 5% sheep blood agar plates. Microbiology The causative pathogens were identified with conventional methods in accordance with the Clinical Laboratory Standard Institute (CLSI) guidelines.13 The 5% sheep blood agar culture plates were maintained at 37! C until sufficient growth had occurred. The plates were subsequently read by a bacteriologist who was blinded to the method of Baseline characteristics of participants in the alcohol-based hand rub and the conventional surgical scrub groups Healthcare workers Attending physician Residents Interns Nurses Allergy to povidone-iodine Presence of wounds on hand Have both allergy to povidone-iodine and presence of wounds on hand Surgeon specialty General surgery Chest surgery Cardiovascular surgery Plastic surgery Neurosurgery Ear-nose-throat surgery Ophthalmologic surgery Orthopedic surgery Urologic surgery Surgical site Head Chest Abdomen Pelvis Spine Extremities Wound classification Clean Clean-contaminated Contaminated Type of surgery Emergency Elective Blood loss amount, median (mL) Blood loss amount > 300 mL Surgery duration, median (min) Gloves wearing duration, median (min) Attending physician Resident physician Intern Operating room nurse Total Alcohol-based hand rub Conventional surgical scrub 128 22 52 9 45 15 23 10 65 13 24 3 25 12 10 8 63 9 28 6 20 3 13 2 0.392 0.386 0.320 0.426 0.025 0.439 0.096 40 16 17 11 9 13 3 6 13 21 7 10 4 0 7 2 6 8 19 9 7 7 9 6 1 0 5 0.793 0.548 0.476 0.360 0.001 0.816 0.999 0.028 0.413 25 28 34 20 4 17 9 8 18 14 0 16 16 20 16 6 4 1 0.099 0.008 0.769 0.061 0.056 <0.001 81 45 2 48 15 2 33 30 0 0.012 0.004 0.496 0.016 2 63 10 (10e80) 9 70 (35e160) 80 (42e151) 66 (37e103) 79 (40e159) 103 (90e119) 90 (48e165) 10 53 20 (10e400) 16 140 (43e241) 105 (47e181) 135 (66e162) 105 (44e252) 59 (32e211) 113 (72e172) 12 116 10 (10e237.5) 25 105 (40e241) 96 (42e164) 84 (45e152) 100 (42e198) 77 (41e163) 102 (53e165) p 0.036 0.099 0.071 0.072 0.102 0.174 0.439 0.392 Efficacy of alcohol-based hand rub Table 2 325 Comparison of the sample cultures and the identified pathogens before and after the operation Before the operation (T0) Positive rate (T0) Identified pathogens Gram-positive Coagulase-negative staphylococci Bacillus Staphylococcus aureus Gram-positive bacilli Micrococcus spp. Corynebacterium spp. Gram-negative Rosemonas spp. Acinetobacter baumannii Moraxella spp. Pseudomonas aeruginosa Klebsiella oxytoca Sphingomonas paucimobilis Multi-pathogens After the operation (T1) Alcohol-based hand rub % (n/N ) Conventional surgical scrub % (n/N ) p Alcohol-based hand rub % (n/N ) 6.15 (4/65) 47.62 (30/63) <0.001 10.77 (7/65) 25.4 (16/63) 0.031 6.15 (4/65) 1.54 (1/65) 42.86 (28/63) 42.86 (27/63) <0.001 <0.001 1.54 (6/65) 6.15 (4/65) 23.81 (15/63) 14.29 (9/63) 0.026 0.152 1.54 (1/65) 3.17 (2/63) 0.616 1.54 (1/65) 1.54 (1/65) 0 3.17 (2/63) 0.999 0.616 1.54 (1/65) 0 3.17 (2/63) 1.59 (1/63) 0.616 0.492 1.54 (1/65) 1.54 (1/65) 0 0 0 1.54 (1/65) 1.59 3.17 1.59 3.17 1.59 3.17 (1/63) (2/63) (1/63) (2/63) (1/63) (2/63) 0.999 0.616 0.492 0.24 0.492 0.616 0 0 1.59 (1/63) 1.59 (1/63) 0.492 0.492 3.17 (2/63) 0.999 0.24 0 1.54 (1/65) 1.59 (1/63) 0 0.492 0.999 1.54 (1/65) 4.76 (3/63) 0.361 1.54 (1/65) 0 Conventional surgical scrub % (n/N ) 0 p T0 Z before surgery; T1 Z after surgery. antisepsis. The positive culture plates were further processed with standard biochemical methods to identify the pathogens. Statistical analysis Data were analyzed by using the PASW Statistics version 18 software (SPSS Inc., Chicago, IL, USA). Proportion comparisons for categorical variables were performed by using Chisquare test. Fisher’s exact test was used when data were sparse. Statistical significance was set at p < 0.05. Variants with p < 0.05 or with clinical importance were further taken into multivariate logistic regression model analysis by using the backward selection to predict the protective factors for positive sample cultures. and 30.16% (control group); p Z 0.793; Table 1]. The alcohol-based hand rub group was involved in more orthopedic surgeries than the conventional surgical scrub group (p Z 0.002) and the conventional surgical scrub group was involved in more neurologic surgeries than the interventional group (p Z 0.014). There was a significant difference in the skin condition between the two groups for an allergic reaction to the povidone-iodine scrub (p Z 0.016). The median blood loss amount was 10 mL in the interventional group and 20 mL in the control group (p Z 0.036). The median surgery duration was 70 minutes in the interventional group and 140 minutes in the control group (p Z 0.071). The median glove wearing duration was 80 minutes in the interventional group and 105 minutes in the control group (p Z 0.072; Table 1). Of the sample cultures Results During the study period, 154 healthcare providers were invited. Twenty-six participants were excluded because of not providing sample cultures after completing surgeries. Therefore, 128 healthcare providers were enrolled for analysisd65 participants were in the interventional group and 63 participants were in the control group. In the interventional group, there were 13 attending physicians, 24 residents, 3 interns, and 25 operating room nurses. In the control group, there were 9 attending physicians, 28 residents, 6 interns, and 20 operating room nurses. There were no significant differences in demographic characteristics between these two groups. However, surgical specialty was a variant, and most people in both groups were involved in general surgery [32.31% (interventional group) Figure 1. Positive rate of sample cultures obtained before the operation and after the operation for alcohol-based hand scrub and conventional surgical scrub groups. 326 N.-J. Shen et al. interventional group were positive and 16 (25.40%) cultures in the control group were positive with a clinically significant difference (p Z 0.031). In both groups, Gram-positive pathogens comprised most of the identified pathogens. There was no significant difference for other identified pathogens (Table 2). obtained before the operations (T0), four (6.15%) cultures in the interventional group were positive and 30 (47.62%) cultures in the control group were positive with a clinically significant difference (p < 0.001). Most identified pathogens were Gram positive. Of the cultures sampled after the operations (T1), seven (10.77%) cultures in the Table 3 cultures Risk factors for positive sample cultures by using multivariate regression analysis for the prediction of positive Type of surgical hand antisepsis Alcohol-based hand rub Conventional surgical scrub Sampling time Before the operation (T0) After the operation (T1) Healthcare workers Attending physician Residents Interns Nurses Allergy to povidone-iodine Presence of wounds on hand Have both allergy to povidone-iodine and presence of wounds on hand Surgery specialty General surgery Chest surgery Cardiovascular surgery Plastic surgery Neurologic surgery Ear-nose-throat surgery Ophthalmologic surgery Orthopedic surgery Urologic surgery Surgical site Head Chest Abdomen Pelvis Spine Extremities Wound classification Clean Clean-contaminated Contaminated Type of surgery Emergent operation Elective Blood loss amount (mL) Surgery duration (min) Gloves wearing duration (min) Attending physician Residents Interns Nurses Positive culture (n Z 57) Negative culture (n Z 199) Univariate analysis p Multivariate analysis p 11 46 119 80 <0.001 <0.001 34 23 94 105 0.098 13 22 0 22 7 16 7 31 82 18 68 23 30 13 0.202 0.724 0.016 0.537 0.881 0.024 0.154 21 5 3 4 6 10 1 1 6 59 27 31 18 12 16 5 11 20 0.302 0.334 0.047 0.792 0.242 0.036 0.999 0.31 0.916 18 9 18 8 1 3 32 47 50 32 7 31 0.009 0.207 0.331 0.708 0.689 0.047 27 28 2 135 62 2 0.005 0.012 0.215 0.555 0.636 8 49 10 (10e200) 96 (40e238) 88 (47e154) 105 (66e151) 48 (40e141) 0 123 (67e178) 16 183 10 (10e250) 108 (40e241) 96 (45e170) 78 (40e153) 105 (42e206) 77 (44e148) 95 (48e160) 0.171 0.915 Data are presented as n or median (range). NA Z non-applicable; T0 Z before surgery; T1 Z after surgery. 0.908 0.935 0.8 0.52 0.152 NA 0.31 0.998 0.543 0.210 0.119 0.499 0.726 0.463 Efficacy of alcohol-based hand rub The culture positive rate was higher in the control group at T0 and at T1 (Fig. 1). We found a trend that the culturepositive rate of the interventional group increased from T0 to T1, whereas the trend of the control group declined from T0 to T1. For outcome analysis, 256 sample cultures were further stratified according to culture results. We had 57 positive sample cultures and 199 negative sample cultures. Most sample cultures in the interventional arm had negative results with a significant difference (p < 0.001). All sample cultures of the interns had negative results (p Z 0.019). We also found that participants who were involved in cardiovascular surgeries had more negative sample cultures (p Z 0.043), whereas participants who were involved in earnose-throat surgeries had more positive sample cultures (p Z 0.036). The participants were more likely to have positive sample cultures when they operated over the patient’s head (p Z 0.009), were involved in surgeries with clean-contaminated wounds (p Z 0.012), or had wounds on their hands (p Z 0.024). By contrast, participants were more likely to have negative sample cultures when they operated over a patient’s extremities (p Z 0.043) or were involved in surgeries with clean wounds (p Z 0.005; Table 3). We used variants with p < 0.05 or with clinical importance into multivariate regression model analysis. Only the alcoholbased hand rub was a protective factor in the positive sample cultures (p < 0.001). Table 3 summarizes the results. Discussion In this prospective observational study, we found that the two-minute three-step alcohol-based hand rub had a lower culture positive rate before and after the operations. Our results suggest that the alcohol-based hand rub is efficient and less time consuming. The increasing use of alcohol-based hand rubs has led to trials studying its efficacy as an alternative to traditional hand scrubbing for hand antisepsis. Olson et al14 conducted a prospective, randomized in vivo study and found that an alcoholbased hand rub was not inferior to alcohol-only products at all sampling points. Burch et al10 compared the efficacy of an alcohol-based hand rub to the traditional 4% chlorhexidine scrub in a cardiac operating room environment. The alcoholbased hand rub showed no difference in comparison to the traditional scrub. A larger study conducted by Weight et al15 evaluated the use of an alcohol-based hand rub or conventional surgical scrub as surgical antisepsis in 3600 pediatric urological operations. The surgical site infection rates between the two groups were similar [2 of 1800 (alcohol-based rub) procedures vs. 3 of 1800 procedures (conventional scrub); p > 0.99]. The insignificant difference may have resulted from the relatively low incidence of surgical site infections. A large sample size is needed to statistically reveal the difference between the two types of hand rub. Another reason for the insignificant difference may be that a different measurement method was used. Larson et al16 focused on different bacterial colony-forming units, whereas our study focused on a positive culture rate and on identifying a specific pathogen. By contrast, our study chose an intermediate end point (i.e., the positive rate of the hand culture), which effectively revealed a significantly lower risk 327 of hand contamination before and after using an alcoholbased hand rub than after using a conventional PVP-I-based or chlorhexidine-based hand rub. In addition, our study involved the most common surgery specialties in the clinical setting, instead of being limited to a specific surgical department; this increased the generalizability of the study results. The positive culture rate of our study was therefore significantly lower with the alcohol-based hand rub. Between the two different hand rub regimens, there was also no difference in the culture rate of highly pathogenic pathogens (e.g., Staphylococcus aureus or Pseudomonas aeruginosa). To date, few studies have evaluated the sustained effect of alcohol-based hand rubs. Mulberry et al17 conducted two randomized, blinded, well-controlled clinical studies involving 137 healthy study participants and proved that the antimicrobial effect of an alcohol-based hand rub could persist more than 3 hours. Choi18 compared an alcohol-based hand rub against a traditional 7.5% PVP-I scrub and found the alcohol-based hand rub had a lower positive culture rate after operations, compared to the traditional scrub. In our study, the positive rate was higher after operations than before operations in the alcohol-based hand rub group. This indicates that the sustained antimicrobial effect of the alcohol-based hand rub may be insufficient. Our study has several limitations. First, our prospective study was a nonrandomized cohort that used volunteer participants. We also excluded volunteers who did not have postoperative microbial surveillance. However, we adapted a standardized sampling method and the microbiology results were observed by a microbiologist who was blinded to the antiseptic regimens. In this way, we could reduce selection bias to a minimum. Second, the average operation duration in our study was relatively short (median time, 1.5 hours). As a result, the data should be generalized with caution for operations of longer duration. Third, our case number was small. Large randomized studies on operations with longer durations are furthermore needed. In conclusion, our results showed that an alcohol-based hand rub was more efficacious than a conventional surgical scrub for surgical antisepsis with sustained efficacy. The rapid bactericidal effect also suggested that an alcoholbased hand rub could be an alternative surgical antiseptic in the operative theaters. Conflict of interest All authors declare that there is no conflict of interest. Acknowledgments We are grateful to the members of the operating theaters for participating in this study. References 1. Delgado-Rodriguez M, Gomez-Ortega A, Llorca J, Lecuona M, Dierssen T, Sillero-Arenas M, et al. Nosocomial infection, indices of intrinsic infection risk, and in-hospital mortality in general surgery. J Hosp Infect 1999;41:203e11. 2. Keen WW. Before and after Lister. Science 1915;41:845e53. 328 3. Rotter ML. Alcohols for antisepsis of hands and skin. In: Ascenzi JM, editor. Handbook of disinfectants and antiseptics. New York: Marcel Dekker; 1996. p. 177e233. 4. Rotter ML. Hand washing and hand disinfection. In: Mayhall CG, editor. Hospital epidemiology and infection control. 2nd ed. Philadelphia PA: Lippincott Williams & Wilkins; 1999. p. 1339e55. 5. Gutierrez CB, Alvarez D, Rodriguez-Barbosa JI, Tascon RI, de la Puente VA, Rodriguez-Ferri EF. In vitro efficacy of N-duopropenide, a recently developed disinfectant containing quaternary ammonium compounds, against selected gram-positive and gram-negative organisms. Am J Vet Res 1999;60:481e4. 6. Herruzo-Cabrera R, Garcia-Caballero J, FernandezAcenero MJ. A new alcohol solution (N-duopropenide) for hygienic (or routine) hand disinfection is more useful than classic handwashing: in vitro and in vivo studies in burn and other intensive care units. Burns 2001;27:747e52. 7. Asensio A, de Gregorio L. Practical experience in a surgical unit when changing from scrub to rub. J Hosp Infect 2013;83(Suppl. 1): S40e2. 8. Kramer A, Bernig T, Kampf G. Clinical double-blind trial on the dermal tolerance and user acceptability of six alcohol-based hand disinfectants for hygienic hand disinfection. J Hosp Infect 2002;51:114e20. 9. Parienti JJ, Thibon P, Heller R, Le Roux Y, von Theobald P, Bensadoun H, et al. Hand-rubbing with an aqueous alcoholic solution vs. traditional surgical hand-scrubbing and 30-day surgical site infection rates: a randomized equivalence study. JAMA 2002;288:722e7. 10. Burch TM, Stanger B, Mizuguchi KA, Zurakowski D, Reid SD. Is alcohol-based hand disinfection equivalent to surgical scrub N.-J. Shen et al. 11. 12. 13. 14. 15. 16. 17. 18. before placing a central venous catheter? Anesth Analg 2012; 114:622e5. Palmer JS. Use of Avagard in pediatric urologic procedures. Urology 2006;68:655e7. Pittet D, Allegranzi B, Boyce J. The World Health Organization guidelines on hand hygiene in health care and their consensus recommendations. Infect Control Hosp Epidemiol 2009;30: 611e22. Clinical and Laboratory Standards Institute (CLSI). Performance standards for antimicrobial susceptibility testing: twenty-first informational supplement M100eS2. Wayne, PA: CLSI; 2011. Olson LK, Morse DJ, Duley C, Savell BK. Prospective, randomized in vivo comparison of a dual-active waterless antiseptic versus two alcohol-only waterless antiseptics for surgical hand antisepsis. Am J Infect Control 2012;40:155e9. Weight CJ, Lee MC, Palmer JS. Avagard hand antisepsis vs. traditional scrub in 3600 pediatric urologic procedures. Urology 2010;76:15e7. Larson EL, Aiello AE, Heilman JM, Lyle CT, Cronquist A, Stahl JB, et al. Comparison of different regimens for surgical hand preparation. AORN J 2001;73:412e4. Mulberrry G, Snyder AT, Heilman J, Pyrek J, Stahl J. Evaluation of a waterless, scrubless chlorhexidine gluconate/ethanol surgical scrub for antimicrobial efficacy. Am J Infect Control 2001;29:377e82. Choi JS. Evaluation of a waterless, scrubless chlorhexidine gluconate/ethanol surgical scrub and povidone-iodine for antimicrobial efficacy. Taehan Kanho Hakhoe Chi 2008;38: 39e44. CONTINUING EDUCATION Back to Basics: Hand Hygiene and Surgical Hand Antisepsis 1.2 LISA SPRUCE, DNP, RN, ACNS, ACNP, ANP, CNOR www.aorn.org/CE Continuing Education Contact Hours Approvals indicates that continuing education (CE) contact hours are available for this activity. Earn the CE contact hours by reading this article, reviewing the purpose/goal and objectives, and completing the online Examination and Learner Evaluation at http://www.aorn.org/CE. A score of 70% correct on the examination is required for credit. Participants receive feedback on incorrect answers. Each applicant who successfully completes this program can immediately print a certificate of completion. This program meets criteria for CNOR and CRNFA recertification, as well as other CE requirements. AORN is provider-approved by the California Board of Registered Nursing, Provider Number CEP 13019. Check with your state board of nursing for acceptance of this activity for relicensure. Event: #13533 Session: #0001 Fee: Members $7.20, Nonmembers $14.40 Dr Spruce has no declared affiliation that could be perceived as posing a potential conflict of interest in the publication of this article. The behavioral objectives for this program were created by Kimberly Retzlaff, managing editor, with consultation from Rebecca Holm, MSN, RN, CNOR, clinical editor, and Susan Bakewell, MS, RN-BC, director, Perioperative Education. Ms Retzlaff, Ms Holm, and Ms Bakewell have no declared affiliations that could be perceived as posing potential conflicts of interest in the publication of this article. The CE contact hours for this article expire November 30, 2016. Pricing is subject to change. Purpose/Goal To provide the learner with knowledge of best practices related to hand hygiene and performing surgical hand antisepsis. Conflict of Interest Disclosures Objectives 1. Discuss common areas of concern that relate to perioperative best practices. 2. Discuss best practices that could enhance safety in the perioperative area. 3. Describe implementation of evidence-based practice in relation to perioperative nursing care. Sponsorship or Commercial Support No sponsorship or commercial support was received for this article. Disclaimer Accreditation AORN is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation. AORN recognizes these activities as CE for RNs. This recognition does not imply that AORN or the American Nurses Credentialing Center approves or endorses products mentioned in the activity. http://dx.doi.org/10.1016/j.aorn.2013.08.017 ! AORN, Inc, 2013 November 2013 Vol 98 No 5 ! AORN Journal j 449 Back to Basics: Hand Hygiene and Surgical Hand Antisepsis 1.2 LISA SPRUCE, DNP, RN, ACNS, ACNP, ANP, CNOR www.aorn.org/CE ABSTRACT Health careeassociated infections (HAIs) are a significant issue in the United States and throughout the world, but following proper hand hygiene practices is the most effective and least expensive way to prevent HAIs. Hand hygiene is inexpensive and protects patients and health care personnel alike. The four general types of hand hygiene that should be performed in the perioperative environment are washing hands that are visibly soiled, hand hygiene using alcohol-based products, surgical hand scrubs, and surgical hand scrubs using an alcohol-based surgical hand rub product. Barriers to proper hand hygiene may include not thinking about it, forgetting, skin irritation, a lack of role models, or a lack of a safety culture. One strategy for improving hand hygiene practices is monitoring hand hygiene as part of a quality improvement project, but the most important aspect for perioperative team members is to set an example for other team members by following proper hand hygiene practices and reminding each other to perform hand hygiene. AORN J 98 (November 2013) 450-457. ! AORN, Inc, 2013. http:// dx.doi.org/10.1016/j.aorn.2013.08.017 Key words: hand hygiene, surgical hand rub, surgical hand scrub, health caree associated infection. I t is appropriate to begin this “Back to Basics” series with hand hygiene and surgical hand antisepsis, because these activities are the foundation of infection prevention for all perioperative personnel. It is probably safe to say that anyone in health care today has heard of the importance of hand hygiene. Hand hygiene is the most effective and least expensive way to prevent health caree associated infections (HAIs).1 All health care workers can prevent HAIs by washing their hands. Health careeassociated infections are a major problem in the United States and throughout the world. In US hospitals, the most frequently occurring HAIs are urinary tract infections (36%), surgical site infections (20%), and blood stream infections and pneumonia (11%).2 The economic effect of these infections was $6.5 billion in 20042 and reached $33.8 billion in 2009.3 Hand hygiene practices can jeopardize safety in the perioperative area if not performed as recommended; if performed correctly, hand hygiene can significantly improve the burden on the global health care system by decreasing microorganism transmission to patients and health care workers. HOW-TO GUIDE The World Health Organization (WHO) Guidelines on Hand Hygiene in Health Care state, http://dx.doi.org/10.1016/j.aorn.2013.08.017 450 j AORN Journal ! November 2013 Vol 98 No 5 ! AORN, Inc, 2013 BACK TO BASICS: HAND HYGIENE Guidelines in the [United States] recommend that agents used for surgical hand preparation should significantly reduce microorganisms on intact skin, contain a non-irritating antimicrobial preparation, have broad-spectrum activity, and be fast-acting and persistent.2(p55) A complete guide to products is included in the WHO guidelines. However, there are basic types of products that should be used in perioperative settings. Alcohol-based hand rubs are the preferred type of product for hand hygiene, while the recommended formulation for surgical hand antisepsis products is more complex and there are multiple antiseptic agents that fit this category.2 The AORN “Recommended practices for hand hygiene”1 recommends that hand hygiene should be performed at numerous times: n n n n n n n n n n www.aornjournal.org should be performed in the perioperative environment: washing hands that are visibly soiled, hand hygiene using alcohol-based products, surgical hand scrubs, and surgical hand scrubs using an alcohol-based surgical hand rub product. There are specific techniques for each of these types of hand hygiene. Washing Hands That Are Visibly Soiled This type of hand hygiene should take 40 to 60 seconds to perform. According to WHO,2 health care personnel should use the following 11-step hand-washing process to ensure their hands are properly cleaned (Figure 1). After wetting hands with water, the following steps should be taken: 1. Apply enough soap to cover all hand surfaces; 2. Rub hands palm to palm; 3. Right palm over left dorsum with interlaced fingers and vice versa; 4. Palm to palm with fingers interlaced; 5. Backs of fingers to opposing palms with fingers interlocked; 6. Rotational rubbing of left thumb clasped in right palm and vice versa; on arrival at the facility, before and after every patient contact, before putting on gloves, after removing gloves, after removing personal protective equipment, after possible contact with blood or other potentially infectious materials, before and after eating, Resources for Hand Hygiene before and after using the Videos restroom, n Hygi! ene des mains H^opitaux Universitaires de Gen!eve Vigi before leaving the Germe. http://youtu.be/0at_jtzJCDM. facility, and n WHO hand hygiene video. http://youtu.be/s08yiZBSGOw. when hands are visibly soiled. Perioperative personnel should review and be mindful of these recommended practices and keep reminders of them visible in a prominent place to help ensure that good practices become habit. There are four general types of hand hygiene that Online resources n Clean care is safer care. World Health Organization. http:// www.who.int/gpsc/5may/background/5moments/en. n Hand hygiene in healthcare settings. Centers for Disease Control and Prevention. http://www.cdc.gov/handhygiene/Resources .html#HCP. n How to wash your hands e hand washing techniques from the NHS. NHS. http://www.wash-hands.com/resources. Web site access verified August 12, 2013. AORN Journal j 451 November 2013 Vol 98 No 5 SPRUCE Figure 1. How to Handwash. http://www.who.int/gpsc/5may/How_To_HandWash_Poster.pdf ª World Health Organization 2009. All rights reserved. Reprinted with permission. 452 j AORN Journal BACK TO BASICS: HAND HYGIENE 7. Rotational rubbing, backwards and forwards with clasped fingers of right hand in left palm and vice versa; 8. Rinse hands with water; 9. Dry hands thoroughly with a single use towel; 10. Use towel to turn off faucet; 11. Your hands are now safe.4 Hand Hygiene Using Alcohol-Based Products During situations in which hands are not visibly soiled, such as after removing gloves or touching a doorknob, perioperative team members should use an alcohol-based hand rub for hand hygiene. This type of hand hygiene process should take 20 to 30 seconds to complete. According to WHO, 2 perioperative team members should use an eightstep hand-rub process to ensure their hands are properly cleaned (Figure 2). If visibly soiled, hands and forearms should be prewashed with plain soap and water or an antimicrobial agent, and then the following steps should be taken: 1. Apply a palmful of the product in a cupped hand, covering all surfaces; 2. Rub hands palm to palm; 3. Right palm over left dorsum with interlaced fingers and vice versa; 4. Palm to palm with fingers interlaced; 5. Backs of fingers to opposing palms with fingers interlocked; 6. Rotational rubbing of left thumb clasped in right palm and vice versa; 7. Rotational rubbing, backwards and forwards with clasped fingers of right hand in left palm and vice versa; 8. Once dry, your hands are safe.5 Surgical Hand Scrub According to AORN,1 a surgical hand scrub should be performed before donning sterile gloves for surgical or other invasive procedures. This process is effective at a duration of three to five minutes. Perioperative team members should use the www.aornjournal.org following steps to ensure their hands are properly cleaned: 1. Remove jewelry including rings, watches, and bracelets. 2. Don a surgical mask. If others are at the scrub sink, a surgical mask should be worn in the presence of hand scrub activity. 3. Wash hands and forearms if visibly soiled with soap and running water immediately before beginning the surgical scrub. 4. Clean the subungual areas of both hands under running water using a disposable nail cleaner. Discard the nail cleaner in the appropriate container. 5. Rinse hands and forearms under running water. 6. Dispense the approved antimicrobial scrub agent according to the manufacturer’s written directions. 7. Apply the antimicrobial agent to wet hands and forearms using a soft, nonabrasive sponge. 8. A three- or five-minute scrub should be timed to allow adequate product contact with skin, according to the manufacturer’s written directions. 9. Visualize each finger, hand, and arm as having four sides. Wash all four sides and the web space, keeping the hand elevated. Repeat this process for opposite fingers, hand, and arm. 10. For water conservation, turn water off when it is not directly in use, if possible. 11. Avoid splashing surgical attire. 12. Discard sponges, if used, in appropriate containers. 13. Hands and arms should be rinsed under running water in one direction from fingertips to elbows as often as needed. 14. Hold hands higher than elbows and away from surgical attire. 15. In the OR, beginning at the fingertips of one hand and working up to the elbow with one end of the towel and repeating the process with the clean end of the towel on the other hand and arm before discarding the towel and donning a sterile surgical gown and gloves.1(p67) AORN Journal j 453 November 2013 Vol 98 No 5 SPRUCE Figure 2. How to Handrub. http://www.who.int/gpsc/5may/How_To_HandRub_Poster.pdf ª World Health Organization 2009. All rights reserved. Reprinted with permission. 454 j AORN Journal BACK TO BASICS: HAND HYGIENE www.aornjournal.org Surgical Hand Scrub Using an AlcoholBased Surgical Hand Rub Product According to AORN,1 an alcohol-based antiseptic surgical hand rub with documented persistent and cumulative activity that has met US Food and Drug Administration regulatory requirements is acceptable. The WHO does not recommend a standardized process for the surgical hand scrub with an alcohol-based product; however, the organization does stress the importance of keeping the hands wet with the product throughout the process.2 The volume of product that should be used depends on the size of the team member’s hands and forearms. After the product is dispensed, the forearms should be the focus of the rub for the first minute and then the hands should be the focus, following the same procedure outlined in the hand scrub technique. To ensure their hands are properly cleaned, perioperative team members should use the following steps during a surgical hand scrub using an alcohol-based surgical hand rub product: 1. Remove jewelry including rings, watches, and bracelets. 2. Don a surgical mask. If others are at the scrub sink, a surgical mask should be worn in the presence of hand scrub activity. 3. If visibly soiled, prewash hands and forearms with plain soap and water or antimicrobial agent. 4. Clean the subungual areas of both hands under running water using a disposable nail cleaner. 5. Rinse hands and forearms under running water. 6. Dry hands and forearms thoroughly with a disposable paper towel. 7. Dispense the manufacturer-recommended amount of the surgical hand rub product. 8. Apply the product to the hands and forearms according to the manufacturer’s written instructions. 9. Repeat the product application process as directed. 10. Rub hands thoroughly until completely dry. During proper hand hygiene, perioperative personnel should a) don a surgical mask, b) rinse the hands from fingertips to elbows, and c) keep surgical attire dry. What’s Wrong With This Picture? reprinted with permission from AORN, Inc, Denver, CO. All rights reserved. 11. In the OR or other invasive procedure room, don a sterile surgical gown and gloves.1(p66-67) BENEFITS Using the four techniques described in the preceding text is the most effective way to prevent and control infections among patients and health care workers. Hand hygiene is inexpensive and achieves a benefit for both populations.1 Hand hygiene reduces the transmission of microorganisms and decreases the incidence of HAIs.3 Evidence supports that a failure to wash hands appropriately is the AORN Journal j 455 November 2013 Vol 98 No 5 leading cause of the spread of multidrug-resistant organisms among patients.3 Surgical hand antisepsis takes hand hygiene a step beyond hand washingdit eliminates transient flora from the hands and reduces resident skin flora.2 Transient flora are colonized on the superficial layers of the skin of the hands and are easily removed with washing, whereas resident skin flora are not only on the superficial layers but also in the deeper layers of the skin and are not as easy to remove.2 TIPS & TRICKS Since 1847, when Ignaz Semmelweis insisted that students and physicians wash their hands, hand hygiene has been a challenge to enforce; today is no different.3 To improve hand hygiene practices, perioperative nurses first need to understand the reasons for poor compliance. Reasons for poor compliance include selfreported factors such as not thinking about it, forgetting, or skin irritation, as well as aspects such as a shortage of role models or lack of a safety culture. Recommended hand hygiene practices may not always be intuitive. Everyone washes their hands when they are visibly soiled, bloody, sticky, or perceived to be dirty. In social situations, people may touch each other by shaking hands, patting each other on the back, hugging, or using touch as affirmation. Hands are not generally washed after these types of contact. These same types of social contact can occur in the health care setting among colleagues and during patient care. Washing the hands after these types of situations may be overlooked, so what can be done to improve compliance with hand hygiene by health care workers? The WHO guideline includes multiple tools to help with improving hand hygiene practices (eg, the Global Patient Safety Challenge document, Pilot Implementation Pack, Hand Hygiene Brochure, Clean Hands Poster, Hand Hygiene Observation Survey).2 Additionally, WHO has a hand hygiene tool kit that provides strategies and tools to those who are interested in improving compliance with 456 j AORN Journal SPRUCE hand hygiene practices at their facilities.6 Some examples include a facility action plan, protocols for hand hygiene, and educational materials and posters. Education is the critical component to improve hand hygiene practices according to WHO.2 The power to inform, along with using other tools, has been proven to increase compliance.2 Another barrier to following hand hygiene practices is skin irritation, which can occur with the use of hand hygiene products. Perioperative team members should remember to let their hands dry completely before donning gloves, and in some cases, alternate products should be provided to personnel who have sensitive or reactive skin. To determine compliance with hand hygiene practices, WHO recommends that individual facilities observe health care workers performing hand hygiene.2 However, no ideal observation method exists currently.2 Facilities have used direct observations by educated observers as well as automated observations, such as video cameras to monitor personnel, with some success; however, direct observation can be biased, as can the interpretation of videos. Furthermore, these methods can be costly and hard to monitor during complex activities.2 It is important for perioperative team members to be examples for each other and remind each other to perform hand hygiene. For a complete discussion on observations and other tools, see the WHO guideline.2 WRAP-UP The effect of HAIs on patient health and safety and the economy is significant. The foundation of infection prevention is hand hygiene; therefore, health care facilities need to make hand hygiene a number one priority in the prevention of HAIs. The goals are to refresh perioperative personnel’s knowledge of hand hygiene and instill a new sense of urgency to protect patients and health care workers from the potential of developing an infection and spreading it to others. BACK TO BASICS: HAND HYGIENE References 1. Recommended practices for hand hygiene. In: Perioperative Standards and Recommended Practices. Denver, CO: AORN, Inc; 2013:63-74. 2. WHO Guidelines on Hand Hygiene in Health Care. Geneva, Switzerland: World Health Organization; 2009. http://whqlibdoc.who.int/publications/2009/9789241597906_ eng.pdf. Accessed September 9, 2013. 3. Guideline for hand hygiene in health-care settings. Recommendations of the Healthcare Infection Control Practices Advisory Committee and the HICPAC/SHEA/APIC/ IDSA Hand Hygiene Task Force. MMWR Recomm Rep. 2002;51(RR-16):1-45. 4. How to Handwash? [poster]. Geneva, Switzerland: World Health Organization; 2009. http://www.who.int/gpsc/5may/ How_To_HandWash_Poster.pdf. Accessed September 13, 2013. 5. How to Handrub? [poster]. Geneva, Switzerland: World Health Organization; 2009. http://www.who.int/gpsc/5may/ www.aornjournal.org How_To_HandRub_Poster.pdf. Accessed September 13, 2013. 6. Guide to Implementation: A Guide to the Implementation of the WHO Multimodal Hand Hygiene Improvement Strategy. Geneva, Switzerland: World Health Organization; 2009. http://whqlibdoc.who.int/hq/2009/WHO_IER_ PSP_2009.02_eng.pdf. Accessed September 9, 2013. Lisa Spruce, DNP, RN, ACNS, ACNP, ANP, CNOR, is the director, Evidence-Based Perioperative Practice, AORN, Inc, Denver, CO. Dr Spruce has no declared affiliation that could be perceived as posing a potential conflict of interest in the publication of this article. Check back in January 2014 for the next “Back to Basics” topic: Hygiene and Cleanliness. AORN Journal j 457 EXAMINATION 1.2 CONTINUING EDUCATION PROGRAM Back to Basics: Hand Hygiene and Surgical Hand Antisepsis www.aorn.org/CE PURPOSE/GOAL To provide the learner with knowledge of best practices related to hand hygiene and performing surgical hand antisepsis. OBJECTIVES 1. Discuss common areas of concern that relate to perioperative best practices. 2. Discuss best practices that could enhance safety in the perioperative area. 3. Describe implementation of evidence-based practice in relation to perioperative nursing care. The Examination and Learner Evaluation are printed here for your convenience. To receive continuing education credit, you must complete the Examination and Learner Evaluation online at http://www.aorn.org/CE. QUESTIONS 1. 2. 5. Hand hygiene practices can 1. decrease microorganism transmission to patients and health care workers. 2. jeopardize safety in the perioperative area if not performed correctly. 3. significantly improve the burden on the global health care system if performed as recommended. a. 1 and 3 b. 1 and 2 c. 2 and 3 d. 1, 2, and 3 According to the World Health Organization, agents used for surgical hand preparation should 1. be fast-acting and persistent. 2. contain a nonirritating antimicrobial preparation. 3. be chlorine based to kill spores. 4. have broad-spectrum activity. 458 j AORN Journal ! November 2013 Vol 98 No 5 significantly reduce microorganisms on intact skin. a. 1 and 2 b. 1 and 3 c. 1, 2, 4, and 5 d. 1, 2, 3, 4, and 5 3. According to AORN, hand hygiene should be performed 1. after removing personal protective equipment. 2. before and after every patient contact. 3. on arrival and before leaving the facility. 4. when hands are visibly soiled. a. 1 and 3 b. 2 and 4 c. 2, 3, and 4 d. 1, 2, 3, and 4 4. Evidence shows that a failure to wash hands appropriately is the leading cause of the spread of multidrug-resistant organisms among patients. a. true b. false ! AORN, Inc, 2013 CE EXAMINATION 5. Strategies that can be used to improve compliance with hand hygiene protocols include 1. creating and implementing a facility action plan. 2. establishing protocols for hand hygiene. 3. mandating one brand of hand hygiene products for all personnel to use. www.aornjournal.org 4. 5. monitoring hand hygiene practices and reporting on findings to personnel. providing personnel with educational materials. a. 2 and 4 b. 1, 2, 4, and 5 c. 1, 3, 4, and 5 d. 1, 2, 3, 4, and 5 AORN Journal j 459 LEARNER EVALUATION 1.2 CONTINUING EDUCATION PROGRAM Back to Basics: Hand Hygiene and Surgical Hand Antisepsis T his evaluation is used to determine the extent to which this continuing education program met your learning needs. Rate the items as described below. OBJECTIVES To what extent were the following objectives of this continuing education program achieved? 1. Discuss common areas of concern that relate to perioperative best practices. Low 1. 2. 3. 4. 5. High 2. Discuss best practices that could enhance safety in the perioperative area. Low 1. 2. 3. 4. 5. High 3. Describe implementation of evidence-based practice in relation to perioperative nursing care. Low 1. 2. 3. 4. 5. High CONTENT 4. To what extent did this article increase your knowledge of the subject matter? Low 1. 2. 3. 4. 5. High 5. To what extent were your individual objectives met? Low 1. 2. 3. 4. 5. High 6. Will you be able to use the information from this article in your work setting? 1. Yes 2. No 7. Will you change your practice as a result of reading this article? (If yes, answer question #7A. If no, answer question #7B.) 460 j AORN Journal ! November 2013 Vol 98 No 5 www.aorn.org/CE 7A. How will you change your practice? (Select all that apply) 1. I will provide education to my team regarding why change is needed. 2. I will work with management to change/ implement a policy and procedure. 3. I will plan an informational meeting with physicians to seek their input and acceptance of the need for change. 4. I will implement change and evaluate the effect of the change at regular intervals until the change is incorporated as best practice. 5. Other: _______________________________ 7B. If you will not change your practice as a result of reading this article, why? (Select all that apply) 1. The content of the article is not relevant to my practice. 2. I do not have enough time to teach others about the purpose of the needed change. 3. I do not have management support to make a change. 4. Other: ________________________________ 8. Our accrediting body requires that we verify the time you needed to complete the 1.2 continuing education contact hour (72-minute) program: _________________________________ ! AORN, Inc, 2013 Journal of Microbiology, Immunology and Infection (2015) 48, 322e328 Available online at www.sciencedirect.com ScienceDirect journal homepage: www.e-jmii.com ORIGINAL ARTICLE Comparative antimicrobial efficacy of alcohol-based hand rub and conventional surgical scrub in a medical center Ni-Jiin Shen a, Sung-Ching Pan a,b, Wang-Huei Sheng a,b,*, Kwei-Lian Tien b, Mei-Ling Chen b, Shan-Chwen Chang b,c, Yee-Chun Chen a,b,c a Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan Center for Infection Control, National Taiwan University Hospital, Taipei, Taiwan c Department of Medicine, National Taiwan University, College of Medicine, Taipei, Taiwan b Received 29 April 2013; received in revised form 30 July 2013; accepted 13 August 2013 Available online 21 September 2013 KEYWORDS Alcohol-based hand rub; Surgical antisepsis; Surgical site infection Background: Hand hygiene is the cornerstone of aseptic techniques to reduce surgical site infection. Conventional surgical scrub is effective for disinfecting a surgeon’s hands. However, the compliance of conventional scrub may be hindered by skin damage, allergy, and time. Alcohol-based hand rub has a satisfactory antimicrobial effect, but mostly in laboratory settings. Our aim was to compare a conventional surgical scrub with an alcohol-based hand rub to evaluate antimicrobial efficacy. Methods: From June 1, 2010 to July 31, 2011, 128 healthcare workers were enrolled in the study. They used an alcohol-based hand rub or a conventional surgical scrub as preoperative hand antisepsis during their routine practice. Hand sampling for cultures were performed before and after operations. Positive culture plates were further processed for pathogen identification. Results: The culture positive rate of the alcohol-based hand rub was 6.2% before operations and 10.8% after operations. Both rates were lower than the conventional surgical scrub [47.6% before operations (p < 0.001) and 25.4% after operations (p Z 0.03)]. The most identified pathogens were Gram-positive with coagulase-negative staphylococci being the major pathogen. Multivariate analysis showed that prior hand condition (p Z 0.21) and type of surgery such as cardiovascular surgery (p Z 0.12) were less relevant, but the alcohol-based hand rub was a significant protective factor for positive hand cultures. * Corresponding author. Department of Internal Medicine, National Taiwan University Hospital, Number 7, Chung-Shan South Road, Taipei 100, Taiwan. E-mail address: [email protected] (W.-H. Sheng). 1684-1182/$36 Copyright ª 2013, Taiwan Society of Microbiology. Published by Elsevier Taiwan LLC. All rights reserved. http://dx.doi.org/10.1016/j.jmii.2013.08.005 Efficacy of alcohol-based hand rub 323 Conclusion: The alcohol-based hand rub was more efficacious for surgical antisepsis and had sustained efficacy, compared to conventional surgical scrub. We suggest that alcohol-based hand rubs could be an alternative surgical antiseptic in the operative theater. Copyright ª 2013, Taiwan Society of Microbiology. Published by Elsevier Taiwan LLC. All rights reserved. Introduction Surgical site infection is a globally recognized problem that results in significant morbidity.1 Joseph Lister was among the first to demonstrate the effect of skin disinfection on reducing surgical site infections.2 Thus, washing hands with antimicrobial soaps, warm water, and frequently with a brush became the primary protocol for surgical hand preparation. Antiseptic soaps should rapidly eliminate transient skin flora and reduce resident flora on the hands to a minimum during a surgical procedure, and thus lower the risk of surgical site contamination if surgical gloves are perforated or torn during surgery.3 Conventional surgical hand antisepsis consists of an aqueous scrub with a brush by using povidone iodine (PVP-I) or chlorhexidine-based detergents. However, scrubbing with these detergents strips skin oils, compromises skin integrity, and (if a brush is used) often causes microabrasions, thereby increasing the risk of subsequent colonization by pathogens.4 As a result, conventional surgical scrub has the disadvantages of skin damage and allergic skin reaction. It is also time consuming to use them. In the laboratory setting, an alcohol-based hand rub is as effective as conventional surgical scrub in its antimicrobial ability.5,6 In addition, skin irritation or dermatitis happened less frequently with an alcohol-based hand rub in a small series of case studies. This can also help increase the compliance of hand washing by healthcare providers in hospitals.7e9 Several alcohol-based hand rubs have been licensed for the commercial market, although there are few clinical studies to compare the antisepsis efficacy against conventional surgical scrub in a routine operating practice environment.10,11 The World Health Organization (WHO) guidelines also state that surgical antisepsis is a state of art, suggesting that there are no optimal antiseptics.12 We conducted a prospective, observational study in our hospital with the aim of comparing a conventional surgical scrub with an alcohol-based hand rub to evaluate their antisepsis efficacy before and after operations. Materials and methods Hospital setting The National Taiwan University Hospital (NTUH) is a medical center with 2388 beds. It comprises three operation theaters with 52 functioning operating rooms (including five delivery rooms). More than 140 surgical procedures were performed daily during 2010 and 2011. The entrance of each operating room is equipped with a sensor sink or a step-operated sink that contains two sets of antisepsis scrubbing facilities. The study was approved by the surgical committee and by the institutional review board of the National Taiwan University Hospital (NTUH-IRB; No. 201109015RC). Inclusion criteria This prospective observational study was conducted from June 1, 2010 to July 31, 2011. The volunteer participants were practicing doctors and nurses who had previous experience with the conventional surgical scrub protocol in the operating environment. They were allocated to the intervention group (i.e., alcohol-based hand rub) or the control group (i.e., conventional surgical scrub), based on their choice (rather than by randomization). All participants were educated and rehearsed in the alcohol-based hand rub protocol prior to this study. The participants’ characteristics such as having an allergy to conventional surgical scrub or having wounds on their hands and the characteristics of the surgeries such as surgical specialty, surgical site, surgical wound classification, type of surgery, blood loss amount, operation duration, and glove wearing duration were recorded. Exclusion criteria Participants were excluded if they did not complete providing samples for culture before the operation (T0) and after the operation (T1). Participants with missing baseline characteristics data were also excluded. Hand preparation and sampling The alcohol-based hand rub contained 1% chlorhexidine gluconate and 61% ethyl alcohol (Avagard; 3M, MN, USA). The standard hand rub protocol was as follows: (1) one pump (2 mL) of lotion was dispensed into the palm of the left hand; (2) the fingertips of the right hand were dipped into the lotion to decontaminate under the nails; (3) the remaining lotion was spread over the right hand and up to just above the elbow; and (4) a second pump (2 mL) of lotion was then placed into the palm of the right hand. This process was repeated by dipping the fingers tip of the left hand into the lotion, followed by spreading it over the left hand and up to just below the elbow. Another 2 mL of lotion was finally placed into cupped hands and reapplied to all aspects of the hands up to the wrists. This solution was then allowed to dry. The three-step application of the alcoholbased hand rub (Avagard) was completed within 2 minutes. The conventional surgical scrub contained 4% chlorhexidine gluconate (Hibiscrub; Janson’s Medical Co., Taipei, 324 N.-J. Shen et al. Taiwan) or 7.5% povidone-iodine. The standard conventional surgical scrub protocol was as follows: (1) three full squirts (6 mL) of PVP-I or chlorhexidine were placed into the cupped hands; (2) this was followed by a five-minute hand scrubbing just up to the elbow by using a sterile scrub brush; and (3) the lotion was rinsed away by tap water. All aforementioned steps were repeated, except the hands were dried with sterile towels, instead of being rinsed with tap water, to avoid recontamination. After hand scrubbing or rubbing protocol, every participant was sampled immediately before the operation (T0). They then performed the scheduled operations. Another sample was obtained after the operation (T1). We used normal saline-moistened sterile cotton swabs to obtain Table 1 specimens for cultures by wiping through every part of the hand (including the ventral and dorsal side of the hands), the fingertips, and the lateral sides of the fingers and the wrists. The samples were immediately inoculated onto 5% sheep blood agar plates. Microbiology The causative pathogens were identified with conventional methods in accordance with the Clinical Laboratory Standard Institute (CLSI) guidelines.13 The 5% sheep blood agar culture plates were maintained at 37! C until sufficient growth had occurred. The plates were subsequently read by a bacteriologist who was blinded to the method of Baseline characteristics of participants in the alcohol-based hand rub and the conventional surgical scrub groups Healthcare workers Attending physician Residents Interns Nurses Allergy to povidone-iodine Presence of wounds on hand Have both allergy to povidone-iodine and presence of wounds on hand Surgeon specialty General surgery Chest surgery Cardiovascular surgery Plastic surgery Neurosurgery Ear-nose-throat surgery Ophthalmologic surgery Orthopedic surgery Urologic surgery Surgical site Head Chest Abdomen Pelvis Spine Extremities Wound classification Clean Clean-contaminated Contaminated Type of surgery Emergency Elective Blood loss amount, median (mL) Blood loss amount > 300 mL Surgery duration, median (min) Gloves wearing duration, median (min) Attending physician Resident physician Intern Operating room nurse Total Alcohol-based hand rub Conventional surgical scrub 128 22 52 9 45 15 23 10 65 13 24 3 25 12 10 8 63 9 28 6 20 3 13 2 0.392 0.386 0.320 0.426 0.025 0.439 0.096 40 16 17 11 9 13 3 6 13 21 7 10 4 0 7 2 6 8 19 9 7 7 9 6 1 0 5 0.793 0.548 0.476 0.360 0.001 0.816 0.999 0.028 0.413 25 28 34 20 4 17 9 8 18 14 0 16 16 20 16 6 4 1 0.099 0.008 0.769 0.061 0.056 <0.001 81 45 2 48 15 2 33 30 0 0.012 0.004 0.496 0.016 2 63 10 (10e80) 9 70 (35e160) 80 (42e151) 66 (37e103) 79 (40e159) 103 (90e119) 90 (48e165) 10 53 20 (10e400) 16 140 (43e241) 105 (47e181) 135 (66e162) 105 (44e252) 59 (32e211) 113 (72e172) 12 116 10 (10e237.5) 25 105 (40e241) 96 (42e164) 84 (45e152) 100 (42e198) 77 (41e163) 102 (53e165) p 0.036 0.099 0.071 0.072 0.102 0.174 0.439 0.392 Efficacy of alcohol-based hand rub Table 2 325 Comparison of the sample cultures and the identified pathogens before and after the operation Before the operation (T0) Positive rate (T0) Identified pathogens Gram-positive Coagulase-negative staphylococci Bacillus Staphylococcus aureus Gram-positive bacilli Micrococcus spp. Corynebacterium spp. Gram-negative Rosemonas spp. Acinetobacter baumannii Moraxella spp. Pseudomonas aeruginosa Klebsiella oxytoca Sphingomonas paucimobilis Multi-pathogens After the operation (T1) Alcohol-based hand rub % (n/N ) Conventional surgical scrub % (n/N ) p Alcohol-based hand rub % (n/N ) 6.15 (4/65) 47.62 (30/63) <0.001 10.77 (7/65) 25.4 (16/63) 0.031 6.15 (4/65) 1.54 (1/65) 42.86 (28/63) 42.86 (27/63) <0.001 <0.001 1.54 (6/65) 6.15 (4/65) 23.81 (15/63) 14.29 (9/63) 0.026 0.152 1.54 (1/65) 3.17 (2/63) 0.616 1.54 (1/65) 1.54 (1/65) 0 3.17 (2/63) 0.999 0.616 1.54 (1/65) 0 3.17 (2/63) 1.59 (1/63) 0.616 0.492 1.54 (1/65) 1.54 (1/65) 0 0 0 1.54 (1/65) 1.59 3.17 1.59 3.17 1.59 3.17 (1/63) (2/63) (1/63) (2/63) (1/63) (2/63) 0.999 0.616 0.492 0.24 0.492 0.616 0 0 1.59 (1/63) 1.59 (1/63) 0.492 0.492 3.17 (2/63) 0.999 0.24 0 1.54 (1/65) 1.59 (1/63) 0 0.492 0.999 1.54 (1/65) 4.76 (3/63) 0.361 1.54 (1/65) 0 Conventional surgical scrub % (n/N ) 0 p T0 Z before surgery; T1 Z after surgery. antisepsis. The positive culture plates were further processed with standard biochemical methods to identify the pathogens. Statistical analysis Data were analyzed by using the PASW Statistics version 18 software (SPSS Inc., Chicago, IL, USA). Proportion comparisons for categorical variables were performed by using Chisquare test. Fisher’s exact test was used when data were sparse. Statistical significance was set at p < 0.05. Variants with p < 0.05 or with clinical importance were further taken into multivariate logistic regression model analysis by using the backward selection to predict the protective factors for positive sample cultures. and 30.16% (control group); p Z 0.793; Table 1]. The alcohol-based hand rub group was involved in more orthopedic surgeries than the conventional surgical scrub group (p Z 0.002) and the conventional surgical scrub group was involved in more neurologic surgeries than the interventional group (p Z 0.014). There was a significant difference in the skin condition between the two groups for an allergic reaction to the povidone-iodine scrub (p Z 0.016). The median blood loss amount was 10 mL in the interventional group and 20 mL in the control group (p Z 0.036). The median surgery duration was 70 minutes in the interventional group and 140 minutes in the control group (p Z 0.071). The median glove wearing duration was 80 minutes in the interventional group and 105 minutes in the control group (p Z 0.072; Table 1). Of the sample cultures Results During the study period, 154 healthcare providers were invited. Twenty-six participants were excluded because of not providing sample cultures after completing surgeries. Therefore, 128 healthcare providers were enrolled for analysisd65 participants were in the interventional group and 63 participants were in the control group. In the interventional group, there were 13 attending physicians, 24 residents, 3 interns, and 25 operating room nurses. In the control group, there were 9 attending physicians, 28 residents, 6 interns, and 20 operating room nurses. There were no significant differences in demographic characteristics between these two groups. However, surgical specialty was a variant, and most people in both groups were involved in general surgery [32.31% (interventional group) Figure 1. Positive rate of sample cultures obtained before the operation and after the operation for alcohol-based hand scrub and conventional surgical scrub groups. 326 N.-J. Shen et al. interventional group were positive and 16 (25.40%) cultures in the control group were positive with a clinically significant difference (p Z 0.031). In both groups, Gram-positive pathogens comprised most of the identified pathogens. There was no significant difference for other identified pathogens (Table 2). obtained before the operations (T0), four (6.15%) cultures in the interventional group were positive and 30 (47.62%) cultures in the control group were positive with a clinically significant difference (p < 0.001). Most identified pathogens were Gram positive. Of the cultures sampled after the operations (T1), seven (10.77%) cultures in the Table 3 cultures Risk factors for positive sample cultures by using multivariate regression analysis for the prediction of positive Type of surgical hand antisepsis Alcohol-based hand rub Conventional surgical scrub Sampling time Before the operation (T0) After the operation (T1) Healthcare workers Attending physician Residents Interns Nurses Allergy to povidone-iodine Presence of wounds on hand Have both allergy to povidone-iodine and presence of wounds on hand Surgery specialty General surgery Chest surgery Cardiovascular surgery Plastic surgery Neurologic surgery Ear-nose-throat surgery Ophthalmologic surgery Orthopedic surgery Urologic surgery Surgical site Head Chest Abdomen Pelvis Spine Extremities Wound classification Clean Clean-contaminated Contaminated Type of surgery Emergent operation Elective Blood loss amount (mL) Surgery duration (min) Gloves wearing duration (min) Attending physician Residents Interns Nurses Positive culture (n Z 57) Negative culture (n Z 199) Univariate analysis p Multivariate analysis p 11 46 119 80 <0.001 <0.001 34 23 94 105 0.098 13 22 0 22 7 16 7 31 82 18 68 23 30 13 0.202 0.724 0.016 0.537 0.881 0.024 0.154 21 5 3 4 6 10 1 1 6 59 27 31 18 12 16 5 11 20 0.302 0.334 0.047 0.792 0.242 0.036 0.999 0.31 0.916 18 9 18 8 1 3 32 47 50 32 7 31 0.009 0.207 0.331 0.708 0.689 0.047 27 28 2 135 62 2 0.005 0.012 0.215 0.555 0.636 8 49 10 (10e200) 96 (40e238) 88 (47e154) 105 (66e151) 48 (40e141) 0 123 (67e178) 16 183 10 (10e250) 108 (40e241) 96 (45e170) 78 (40e153) 105 (42e206) 77 (44e148) 95 (48e160) 0.171 0.915 Data are presented as n or median (range). NA Z non-applicable; T0 Z before surgery; T1 Z after surgery. 0.908 0.935 0.8 0.52 0.152 NA 0.31 0.998 0.543 0.210 0.119 0.499 0.726 0.463 Efficacy of alcohol-based hand rub The culture positive rate was higher in the control group at T0 and at T1 (Fig. 1). We found a trend that the culturepositive rate of the interventional group increased from T0 to T1, whereas the trend of the control group declined from T0 to T1. For outcome analysis, 256 sample cultures were further stratified according to culture results. We had 57 positive sample cultures and 199 negative sample cultures. Most sample cultures in the interventional arm had negative results with a significant difference (p < 0.001). All sample cultures of the interns had negative results (p Z 0.019). We also found that participants who were involved in cardiovascular surgeries had more negative sample cultures (p Z 0.043), whereas participants who were involved in earnose-throat surgeries had more positive sample cultures (p Z 0.036). The participants were more likely to have positive sample cultures when they operated over the patient’s head (p Z 0.009), were involved in surgeries with clean-contaminated wounds (p Z 0.012), or had wounds on their hands (p Z 0.024). By contrast, participants were more likely to have negative sample cultures when they operated over a patient’s extremities (p Z 0.043) or were involved in surgeries with clean wounds (p Z 0.005; Table 3). We used variants with p < 0.05 or with clinical importance into multivariate regression model analysis. Only the alcoholbased hand rub was a protective factor in the positive sample cultures (p < 0.001). Table 3 summarizes the results. Discussion In this prospective observational study, we found that the two-minute three-step alcohol-based hand rub had a lower culture positive rate before and after the operations. Our results suggest that the alcohol-based hand rub is efficient and less time consuming. The increasing use of alcohol-based hand rubs has led to trials studying its efficacy as an alternative to traditional hand scrubbing for hand antisepsis. Olson et al14 conducted a prospective, randomized in vivo study and found that an alcoholbased hand rub was not inferior to alcohol-only products at all sampling points. Burch et al10 compared the efficacy of an alcohol-based hand rub to the traditional 4% chlorhexidine scrub in a cardiac operating room environment. The alcoholbased hand rub showed no difference in comparison to the traditional scrub. A larger study conducted by Weight et al15 evaluated the use of an alcohol-based hand rub or conventional surgical scrub as surgical antisepsis in 3600 pediatric urological operations. The surgical site infection rates between the two groups were similar [2 of 1800 (alcohol-based rub) procedures vs. 3 of 1800 procedures (conventional scrub); p > 0.99]. The insignificant difference may have resulted from the relatively low incidence of surgical site infections. A large sample size is needed to statistically reveal the difference between the two types of hand rub. Another reason for the insignificant difference may be that a different measurement method was used. Larson et al16 focused on different bacterial colony-forming units, whereas our study focused on a positive culture rate and on identifying a specific pathogen. By contrast, our study chose an intermediate end point (i.e., the positive rate of the hand culture), which effectively revealed a significantly lower risk 327 of hand contamination before and after using an alcoholbased hand rub than after using a conventional PVP-I-based or chlorhexidine-based hand rub. In addition, our study involved the most common surgery specialties in the clinical setting, instead of being limited to a specific surgical department; this increased the generalizability of the study results. The positive culture rate of our study was therefore significantly lower with the alcohol-based hand rub. Between the two different hand rub regimens, there was also no difference in the culture rate of highly pathogenic pathogens (e.g., Staphylococcus aureus or Pseudomonas aeruginosa). To date, few studies have evaluated the sustained effect of alcohol-based hand rubs. Mulberry et al17 conducted two randomized, blinded, well-controlled clinical studies involving 137 healthy study participants and proved that the antimicrobial effect of an alcohol-based hand rub could persist more than 3 hours. Choi18 compared an alcohol-based hand rub against a traditional 7.5% PVP-I scrub and found the alcohol-based hand rub had a lower positive culture rate after operations, compared to the traditional scrub. In our study, the positive rate was higher after operations than before operations in the alcohol-based hand rub group. This indicates that the sustained antimicrobial effect of the alcohol-based hand rub may be insufficient. Our study has several limitations. First, our prospective study was a nonrandomized cohort that used volunteer participants. We also excluded volunteers who did not have postoperative microbial surveillance. However, we adapted a standardized sampling method and the microbiology results were observed by a microbiologist who was blinded to the antiseptic regimens. In this way, we could reduce selection bias to a minimum. Second, the average operation duration in our study was relatively short (median time, 1.5 hours). As a result, the data should be generalized with caution for operations of longer duration. Third, our case number was small. Large randomized studies on operations with longer durations are furthermore needed. In conclusion, our results showed that an alcohol-based hand rub was more efficacious than a conventional surgical scrub for surgical antisepsis with sustained efficacy. The rapid bactericidal effect also suggested that an alcoholbased hand rub could be an alternative surgical antiseptic in the operative theaters. Conflict of interest All authors declare that there is no conflict of interest. Acknowledgments We are grateful to the members of the operating theaters for participating in this study. References 1. Delgado-Rodriguez M, Gomez-Ortega A, Llorca J, Lecuona M, Dierssen T, Sillero-Arenas M, et al. Nosocomial infection, indices of intrinsic infection risk, and in-hospital mortality in general surgery. J Hosp Infect 1999;41:203e11. 2. Keen WW. Before and after Lister. Science 1915;41:845e53. 328 3. Rotter ML. Alcohols for antisepsis of hands and skin. In: Ascenzi JM, editor. Handbook of disinfectants and antiseptics. New York: Marcel Dekker; 1996. p. 177e233. 4. Rotter ML. Hand washing and hand disinfection. In: Mayhall CG, editor. Hospital epidemiology and infection control. 2nd ed. Philadelphia PA: Lippincott Williams & Wilkins; 1999. p. 1339e55. 5. Gutierrez CB, Alvarez D, Rodriguez-Barbosa JI, Tascon RI, de la Puente VA, Rodriguez-Ferri EF. In vitro efficacy of N-duopropenide, a recently developed disinfectant containing quaternary ammonium compounds, against selected gram-positive and gram-negative organisms. Am J Vet Res 1999;60:481e4. 6. Herruzo-Cabrera R, Garcia-Caballero J, FernandezAcenero MJ. A new alcohol solution (N-duopropenide) for hygienic (or routine) hand disinfection is more useful than classic handwashing: in vitro and in vivo studies in burn and other intensive care units. Burns 2001;27:747e52. 7. Asensio A, de Gregorio L. Practical experience in a surgical unit when changing from scrub to rub. J Hosp Infect 2013;83(Suppl. 1): S40e2. 8. Kramer A, Bernig T, Kampf G. Clinical double-blind trial on the dermal tolerance and user acceptability of six alcohol-based hand disinfectants for hygienic hand disinfection. J Hosp Infect 2002;51:114e20. 9. Parienti JJ, Thibon P, Heller R, Le Roux Y, von Theobald P, Bensadoun H, et al. Hand-rubbing with an aqueous alcoholic solution vs. traditional surgical hand-scrubbing and 30-day surgical site infection rates: a randomized equivalence study. JAMA 2002;288:722e7. 10. Burch TM, Stanger B, Mizuguchi KA, Zurakowski D, Reid SD. Is alcohol-based hand disinfection equivalent to surgical scrub N.-J. Shen et al. 11. 12. 13. 14. 15. 16. 17. 18. before placing a central venous catheter? Anesth Analg 2012; 114:622e5. Palmer JS. Use of Avagard in pediatric urologic procedures. Urology 2006;68:655e7. Pittet D, Allegranzi B, Boyce J. The World Health Organization guidelines on hand hygiene in health care and their consensus recommendations. Infect Control Hosp Epidemiol 2009;30: 611e22. Clinical and Laboratory Standards Institute (CLSI). Performance standards for antimicrobial susceptibility testing: twenty-first informational supplement M100eS2. Wayne, PA: CLSI; 2011. Olson LK, Morse DJ, Duley C, Savell BK. Prospective, randomized in vivo comparison of a dual-active waterless antiseptic versus two alcohol-only waterless antiseptics for surgical hand antisepsis. Am J Infect Control 2012;40:155e9. Weight CJ, Lee MC, Palmer JS. Avagard hand antisepsis vs. traditional scrub in 3600 pediatric urologic procedures. Urology 2010;76:15e7. Larson EL, Aiello AE, Heilman JM, Lyle CT, Cronquist A, Stahl JB, et al. Comparison of different regimens for surgical hand preparation. AORN J 2001;73:412e4. Mulberrry G, Snyder AT, Heilman J, Pyrek J, Stahl J. Evaluation of a waterless, scrubless chlorhexidine gluconate/ethanol surgical scrub for antimicrobial efficacy. Am J Infect Control 2001;29:377e82. Choi JS. Evaluation of a waterless, scrubless chlorhexidine gluconate/ethanol surgical scrub and povidone-iodine for antimicrobial efficacy. Taehan Kanho Hakhoe Chi 2008;38: 39e44. CONTINUING EDUCATION Back to Basics: Hand Hygiene and Surgical Hand Antisepsis 1.2 LISA SPRUCE, DNP, RN, ACNS, ACNP, ANP, CNOR www.aorn.org/CE Continuing Education Contact Hours Approvals indicates that continuing education (CE) contact hours are available for this activity. Earn the CE contact hours by reading this article, reviewing the purpose/goal and objectives, and completing the online Examination and Learner Evaluation at http://www.aorn.org/CE. A score of 70% correct on the examination is required for credit. Participants receive feedback on incorrect answers. Each applicant who successfully completes this program can immediately print a certificate of completion. This program meets criteria for CNOR and CRNFA recertification, as well as other CE requirements. AORN is provider-approved by the California Board of Registered Nursing, Provider Number CEP 13019. Check with your state board of nursing for acceptance of this activity for relicensure. Event: #13533 Session: #0001 Fee: Members $7.20, Nonmembers $14.40 Dr Spruce has no declared affiliation that could be perceived as posing a potential conflict of interest in the publication of this article. The behavioral objectives for this program were created by Kimberly Retzlaff, managing editor, with consultation from Rebecca Holm, MSN, RN, CNOR, clinical editor, and Susan Bakewell, MS, RN-BC, director, Perioperative Education. Ms Retzlaff, Ms Holm, and Ms Bakewell have no declared affiliations that could be perceived as posing potential conflicts of interest in the publication of this article. The CE contact hours for this article expire November 30, 2016. Pricing is subject to change. Purpose/Goal To provide the learner with knowledge of best practices related to hand hygiene and performing surgical hand antisepsis. Conflict of Interest Disclosures Objectives 1. Discuss common areas of concern that relate to perioperative best practices. 2. Discuss best practices that could enhance safety in the perioperative area. 3. Describe implementation of evidence-based practice in relation to perioperative nursing care. Sponsorship or Commercial Support No sponsorship or commercial support was received for this article. Disclaimer Accreditation AORN is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation. AORN recognizes these activities as CE for RNs. This recognition does not imply that AORN or the American Nurses Credentialing Center approves or endorses products mentioned in the activity. http://dx.doi.org/10.1016/j.aorn.2013.08.017 ! AORN, Inc, 2013 November 2013 Vol 98 No 5 ! AORN Journal j 449 Back to Basics: Hand Hygiene and Surgical Hand Antisepsis 1.2 LISA SPRUCE, DNP, RN, ACNS, ACNP, ANP, CNOR www.aorn.org/CE ABSTRACT Health careeassociated infections (HAIs) are a significant issue in the United States and throughout the world, but following proper hand hygiene practices is the most effective and least expensive way to prevent HAIs. Hand hygiene is inexpensive and protects patients and health care personnel alike. The four general types of hand hygiene that should be performed in the perioperative environment are washing hands that are visibly soiled, hand hygiene using alcohol-based products, surgical hand scrubs, and surgical hand scrubs using an alcohol-based surgical hand rub product. Barriers to proper hand hygiene may include not thinking about it, forgetting, skin irritation, a lack of role models, or a lack of a safety culture. One strategy for improving hand hygiene practices is monitoring hand hygiene as part of a quality improvement project, but the most important aspect for perioperative team members is to set an example for other team members by following proper hand hygiene practices and reminding each other to perform hand hygiene. AORN J 98 (November 2013) 450-457. ! AORN, Inc, 2013. http:// dx.doi.org/10.1016/j.aorn.2013.08.017 Key words: hand hygiene, surgical hand rub, surgical hand scrub, health caree associated infection. I t is appropriate to begin this “Back to Basics” series with hand hygiene and surgical hand antisepsis, because these activities are the foundation of infection prevention for all perioperative personnel. It is probably safe to say that anyone in health care today has heard of the importance of hand hygiene. Hand hygiene is the most effective and least expensive way to prevent health caree associated infections (HAIs).1 All health care workers can prevent HAIs by washing their hands. Health careeassociated infections are a major problem in the United States and throughout the world. In US hospitals, the most frequently occurring HAIs are urinary tract infections (36%), surgical site infections (20%), and blood stream infections and pneumonia (11%).2 The economic effect of these infections was $6.5 billion in 20042 and reached $33.8 billion in 2009.3 Hand hygiene practices can jeopardize safety in the perioperative area if not performed as recommended; if performed correctly, hand hygiene can significantly improve the burden on the global health care system by decreasing microorganism transmission to patients and health care workers. HOW-TO GUIDE The World Health Organization (WHO) Guidelines on Hand Hygiene in Health Care state, http://dx.doi.org/10.1016/j.aorn.2013.08.017 450 j AORN Journal ! November 2013 Vol 98 No 5 ! AORN, Inc, 2013 BACK TO BASICS: HAND HYGIENE Guidelines in the [United States] recommend that agents used for surgical hand preparation should significantly reduce microorganisms on intact skin, contain a non-irritating antimicrobial preparation, have broad-spectrum activity, and be fast-acting and persistent.2(p55) A complete guide to products is included in the WHO guidelines. However, there are basic types of products that should be used in perioperative settings. Alcohol-based hand rubs are the preferred type of product for hand hygiene, while the recommended formulation for surgical hand antisepsis products is more complex and there are multiple antiseptic agents that fit this category.2 The AORN “Recommended practices for hand hygiene”1 recommends that hand hygiene should be performed at numerous times: n n n n n n n n n n www.aornjournal.org should be performed in the perioperative environment: washing hands that are visibly soiled, hand hygiene using alcohol-based products, surgical hand scrubs, and surgical hand scrubs using an alcohol-based surgical hand rub product. There are specific techniques for each of these types of hand hygiene. Washing Hands That Are Visibly Soiled This type of hand hygiene should take 40 to 60 seconds to perform. According to WHO,2 health care personnel should use the following 11-step hand-washing process to ensure their hands are properly cleaned (Figure 1). After wetting hands with water, the following steps should be taken: 1. Apply enough soap to cover all hand surfaces; 2. Rub hands palm to palm; 3. Right palm over left dorsum with interlaced fingers and vice versa; 4. Palm to palm with fingers interlaced; 5. Backs of fingers to opposing palms with fingers interlocked; 6. Rotational rubbing of left thumb clasped in right palm and vice versa; on arrival at the facility, before and after every patient contact, before putting on gloves, after removing gloves, after removing personal protective equipment, after possible contact with blood or other potentially infectious materials, before and after eating, Resources for Hand Hygiene before and after using the Videos restroom, n Hygi! ene des mains H^opitaux Universitaires de Gen!eve Vigi before leaving the Germe. http://youtu.be/0at_jtzJCDM. facility, and n WHO hand hygiene video. http://youtu.be/s08yiZBSGOw. when hands are visibly soiled. Perioperative personnel should review and be mindful of these recommended practices and keep reminders of them visible in a prominent place to help ensure that good practices become habit. There are four general types of hand hygiene that Online resources n Clean care is safer care. World Health Organization. http:// www.who.int/gpsc/5may/background/5moments/en. n Hand hygiene in healthcare settings. Centers for Disease Control and Prevention. http://www.cdc.gov/handhygiene/Resources .html#HCP. n How to wash your hands e hand washing techniques from the NHS. NHS. http://www.wash-hands.com/resources. Web site access verified August 12, 2013. AORN Journal j 451 November 2013 Vol 98 No 5 SPRUCE Figure 1. How to Handwash. http://www.who.int/gpsc/5may/How_To_HandWash_Poster.pdf ª World Health Organization 2009. All rights reserved. Reprinted with permission. 452 j AORN Journal BACK TO BASICS: HAND HYGIENE 7. Rotational rubbing, backwards and forwards with clasped fingers of right hand in left palm and vice versa; 8. Rinse hands with water; 9. Dry hands thoroughly with a single use towel; 10. Use towel to turn off faucet; 11. Your hands are now safe.4 Hand Hygiene Using Alcohol-Based Products During situations in which hands are not visibly soiled, such as after removing gloves or touching a doorknob, perioperative team members should use an alcohol-based hand rub for hand hygiene. This type of hand hygiene process should take 20 to 30 seconds to complete. According to WHO, 2 perioperative team members should use an eightstep hand-rub process to ensure their hands are properly cleaned (Figure 2). If visibly soiled, hands and forearms should be prewashed with plain soap and water or an antimicrobial agent, and then the following steps should be taken: 1. Apply a palmful of the product in a cupped hand, covering all surfaces; 2. Rub hands palm to palm; 3. Right palm over left dorsum with interlaced fingers and vice versa; 4. Palm to palm with fingers interlaced; 5. Backs of fingers to opposing palms with fingers interlocked; 6. Rotational rubbing of left thumb clasped in right palm and vice versa; 7. Rotational rubbing, backwards and forwards with clasped fingers of right hand in left palm and vice versa; 8. Once dry, your hands are safe.5 Surgical Hand Scrub According to AORN,1 a surgical hand scrub should be performed before donning sterile gloves for surgical or other invasive procedures. This process is effective at a duration of three to five minutes. Perioperative team members should use the www.aornjournal.org following steps to ensure their hands are properly cleaned: 1. Remove jewelry including rings, watches, and bracelets. 2. Don a surgical mask. If others are at the scrub sink, a surgical mask should be worn in the presence of hand scrub activity. 3. Wash hands and forearms if visibly soiled with soap and running water immediately before beginning the surgical scrub. 4. Clean the subungual areas of both hands under running water using a disposable nail cleaner. Discard the nail cleaner in the appropriate container. 5. Rinse hands and forearms under running water. 6. Dispense the approved antimicrobial scrub agent according to the manufacturer’s written directions. 7. Apply the antimicrobial agent to wet hands and forearms using a soft, nonabrasive sponge. 8. A three- or five-minute scrub should be timed to allow adequate product contact with skin, according to the manufacturer’s written directions. 9. Visualize each finger, hand, and arm as having four sides. Wash all four sides and the web space, keeping the hand elevated. Repeat this process for opposite fingers, hand, and arm. 10. For water conservation, turn water off when it is not directly in use, if possible. 11. Avoid splashing surgical attire. 12. Discard sponges, if used, in appropriate containers. 13. Hands and arms should be rinsed under running water in one direction from fingertips to elbows as often as needed. 14. Hold hands higher than elbows and away from surgical attire. 15. In the OR, beginning at the fingertips of one hand and working up to the elbow with one end of the towel and repeating the process with the clean end of the towel on the other hand and arm before discarding the towel and donning a sterile surgical gown and gloves.1(p67) AORN Journal j 453 November 2013 Vol 98 No 5 SPRUCE Figure 2. How to Handrub. http://www.who.int/gpsc/5may/How_To_HandRub_Poster.pdf ª World Health Organization 2009. All rights reserved. Reprinted with permission. 454 j AORN Journal BACK TO BASICS: HAND HYGIENE www.aornjournal.org Surgical Hand Scrub Using an AlcoholBased Surgical Hand Rub Product According to AORN,1 an alcohol-based antiseptic surgical hand rub with documented persistent and cumulative activity that has met US Food and Drug Administration regulatory requirements is acceptable. The WHO does not recommend a standardized process for the surgical hand scrub with an alcohol-based product; however, the organization does stress the importance of keeping the hands wet with the product throughout the process.2 The volume of product that should be used depends on the size of the team member’s hands and forearms. After the product is dispensed, the forearms should be the focus of the rub for the first minute and then the hands should be the focus, following the same procedure outlined in the hand scrub technique. To ensure their hands are properly cleaned, perioperative team members should use the following steps during a surgical hand scrub using an alcohol-based surgical hand rub product: 1. Remove jewelry including rings, watches, and bracelets. 2. Don a surgical mask. If others are at the scrub sink, a surgical mask should be worn in the presence of hand scrub activity. 3. If visibly soiled, prewash hands and forearms with plain soap and water or antimicrobial agent. 4. Clean the subungual areas of both hands under running water using a disposable nail cleaner. 5. Rinse hands and forearms under running water. 6. Dry hands and forearms thoroughly with a disposable paper towel. 7. Dispense the manufacturer-recommended amount of the surgical hand rub product. 8. Apply the product to the hands and forearms according to the manufacturer’s written instructions. 9. Repeat the product application process as directed. 10. Rub hands thoroughly until completely dry. During proper hand hygiene, perioperative personnel should a) don a surgical mask, b) rinse the hands from fingertips to elbows, and c) keep surgical attire dry. What’s Wrong With This Picture? reprinted with permission from AORN, Inc, Denver, CO. All rights reserved. 11. In the OR or other invasive procedure room, don a sterile surgical gown and gloves.1(p66-67) BENEFITS Using the four techniques described in the preceding text is the most effective way to prevent and control infections among patients and health care workers. Hand hygiene is inexpensive and achieves a benefit for both populations.1 Hand hygiene reduces the transmission of microorganisms and decreases the incidence of HAIs.3 Evidence supports that a failure to wash hands appropriately is the AORN Journal j 455 November 2013 Vol 98 No 5 leading cause of the spread of multidrug-resistant organisms among patients.3 Surgical hand antisepsis takes hand hygiene a step beyond hand washingdit eliminates transient flora from the hands and reduces resident skin flora.2 Transient flora are colonized on the superficial layers of the skin of the hands and are easily removed with washing, whereas resident skin flora are not only on the superficial layers but also in the deeper layers of the skin and are not as easy to remove.2 TIPS & TRICKS Since 1847, when Ignaz Semmelweis insisted that students and physicians wash their hands, hand hygiene has been a challenge to enforce; today is no different.3 To improve hand hygiene practices, perioperative nurses first need to understand the reasons for poor compliance. Reasons for poor compliance include selfreported factors such as not thinking about it, forgetting, or skin irritation, as well as aspects such as a shortage of role models or lack of a safety culture. Recommended hand hygiene practices may not always be intuitive. Everyone washes their hands when they are visibly soiled, bloody, sticky, or perceived to be dirty. In social situations, people may touch each other by shaking hands, patting each other on the back, hugging, or using touch as affirmation. Hands are not generally washed after these types of contact. These same types of social contact can occur in the health care setting among colleagues and during patient care. Washing the hands after these types of situations may be overlooked, so what can be done to improve compliance with hand hygiene by health care workers? The WHO guideline includes multiple tools to help with improving hand hygiene practices (eg, the Global Patient Safety Challenge document, Pilot Implementation Pack, Hand Hygiene Brochure, Clean Hands Poster, Hand Hygiene Observation Survey).2 Additionally, WHO has a hand hygiene tool kit that provides strategies and tools to those who are interested in improving compliance with 456 j AORN Journal SPRUCE hand hygiene practices at their facilities.6 Some examples include a facility action plan, protocols for hand hygiene, and educational materials and posters. Education is the critical component to improve hand hygiene practices according to WHO.2 The power to inform, along with using other tools, has been proven to increase compliance.2 Another barrier to following hand hygiene practices is skin irritation, which can occur with the use of hand hygiene products. Perioperative team members should remember to let their hands dry completely before donning gloves, and in some cases, alternate products should be provided to personnel who have sensitive or reactive skin. To determine compliance with hand hygiene practices, WHO recommends that individual facilities observe health care workers performing hand hygiene.2 However, no ideal observation method exists currently.2 Facilities have used direct observations by educated observers as well as automated observations, such as video cameras to monitor personnel, with some success; however, direct observation can be biased, as can the interpretation of videos. Furthermore, these methods can be costly and hard to monitor during complex activities.2 It is important for perioperative team members to be examples for each other and remind each other to perform hand hygiene. For a complete discussion on observations and other tools, see the WHO guideline.2 WRAP-UP The effect of HAIs on patient health and safety and the economy is significant. The foundation of infection prevention is hand hygiene; therefore, health care facilities need to make hand hygiene a number one priority in the prevention of HAIs. The goals are to refresh perioperative personnel’s knowledge of hand hygiene and instill a new sense of urgency to protect patients and health care workers from the potential of developing an infection and spreading it to others. BACK TO BASICS: HAND HYGIENE References 1. Recommended practices for hand hygiene. In: Perioperative Standards and Recommended Practices. Denver, CO: AORN, Inc; 2013:63-74. 2. WHO Guidelines on Hand Hygiene in Health Care. Geneva, Switzerland: World Health Organization; 2009. http://whqlibdoc.who.int/publications/2009/9789241597906_ eng.pdf. Accessed September 9, 2013. 3. Guideline for hand hygiene in health-care settings. Recommendations of the Healthcare Infection Control Practices Advisory Committee and the HICPAC/SHEA/APIC/ IDSA Hand Hygiene Task Force. MMWR Recomm Rep. 2002;51(RR-16):1-45. 4. How to Handwash? [poster]. Geneva, Switzerland: World Health Organization; 2009. http://www.who.int/gpsc/5may/ How_To_HandWash_Poster.pdf. Accessed September 13, 2013. 5. How to Handrub? [poster]. Geneva, Switzerland: World Health Organization; 2009. http://www.who.int/gpsc/5may/ www.aornjournal.org How_To_HandRub_Poster.pdf. Accessed September 13, 2013. 6. Guide to Implementation: A Guide to the Implementation of the WHO Multimodal Hand Hygiene Improvement Strategy. Geneva, Switzerland: World Health Organization; 2009. http://whqlibdoc.who.int/hq/2009/WHO_IER_ PSP_2009.02_eng.pdf. Accessed September 9, 2013. Lisa Spruce, DNP, RN, ACNS, ACNP, ANP, CNOR, is the director, Evidence-Based Perioperative Practice, AORN, Inc, Denver, CO. Dr Spruce has no declared affiliation that could be perceived as posing a potential conflict of interest in the publication of this article. Check back in January 2014 for the next “Back to Basics” topic: Hygiene and Cleanliness. AORN Journal j 457 EXAMINATION 1.2 CONTINUING EDUCATION PROGRAM Back to Basics: Hand Hygiene and Surgical Hand Antisepsis www.aorn.org/CE PURPOSE/GOAL To provide the learner with knowledge of best practices related to hand hygiene and performing surgical hand antisepsis. OBJECTIVES 1. Discuss common areas of concern that relate to perioperative best practices. 2. Discuss best practices that could enhance safety in the perioperative area. 3. Describe implementation of evidence-based practice in relation to perioperative nursing care. The Examination and Learner Evaluation are printed here for your convenience. To receive continuing education credit, you must complete the Examination and Learner Evaluation online at http://www.aorn.org/CE. QUESTIONS 1. 2. 5. Hand hygiene practices can 1. decrease microorganism transmission to patients and health care workers. 2. jeopardize safety in the perioperative area if not performed correctly. 3. significantly improve the burden on the global health care system if performed as recommended. a. 1 and 3 b. 1 and 2 c. 2 and 3 d. 1, 2, and 3 According to the World Health Organization, agents used for surgical hand preparation should 1. be fast-acting and persistent. 2. contain a nonirritating antimicrobial preparation. 3. be chlorine based to kill spores. 4. have broad-spectrum activity. 458 j AORN Journal ! November 2013 Vol 98 No 5 significantly reduce microorganisms on intact skin. a. 1 and 2 b. 1 and 3 c. 1, 2, 4, and 5 d. 1, 2, 3, 4, and 5 3. According to AORN, hand hygiene should be performed 1. after removing personal protective equipment. 2. before and after every patient contact. 3. on arrival and before leaving the facility. 4. when hands are visibly soiled. a. 1 and 3 b. 2 and 4 c. 2, 3, and 4 d. 1, 2, 3, and 4 4. Evidence shows that a failure to wash hands appropriately is the leading cause of the spread of multidrug-resistant organisms among patients. a. true b. false ! AORN, Inc, 2013 CE EXAMINATION 5. Strategies that can be used to improve compliance with hand hygiene protocols include 1. creating and implementing a facility action plan. 2. establishing protocols for hand hygiene. 3. mandating one brand of hand hygiene products for all personnel to use. www.aornjournal.org 4. 5. monitoring hand hygiene practices and reporting on findings to personnel. providing personnel with educational materials. a. 2 and 4 b. 1, 2, 4, and 5 c. 1, 3, 4, and 5 d. 1, 2, 3, 4, and 5 AORN Journal j 459 LEARNER EVALUATION 1.2 CONTINUING EDUCATION PROGRAM Back to Basics: Hand Hygiene and Surgical Hand Antisepsis T his evaluation is used to determine the extent to which this continuing education program met your learning needs. Rate the items as described below. OBJECTIVES To what extent were the following objectives of this continuing education program achieved? 1. Discuss common areas of concern that relate to perioperative best practices. Low 1. 2. 3. 4. 5. High 2. Discuss best practices that could enhance safety in the perioperative area. Low 1. 2. 3. 4. 5. High 3. Describe implementation of evidence-based practice in relation to perioperative nursing care. Low 1. 2. 3. 4. 5. High CONTENT 4. To what extent did this article increase your knowledge of the subject matter? Low 1. 2. 3. 4. 5. High 5. To what extent were your individual objectives met? Low 1. 2. 3. 4. 5. High 6. Will you be able to use the information from this article in your work setting? 1. Yes 2. No 7. Will you change your practice as a result of reading this article? (If yes, answer question #7A. If no, answer question #7B.) 460 j AORN Journal ! November 2013 Vol 98 No 5 www.aorn.org/CE 7A. How will you change your practice? (Select all that apply) 1. I will provide education to my team regarding why change is needed. 2. I will work with management to change/ implement a policy and procedure. 3. I will plan an informational meeting with physicians to seek their input and acceptance of the need for change. 4. I will implement change and evaluate the effect of the change at regular intervals until the change is incorporated as best practice. 5. Other: _______________________________ 7B. If you will not change your practice as a result of reading this article, why? (Select all that apply) 1. The content of the article is not relevant to my practice. 2. I do not have enough time to teach others about the purpose of the needed change. 3. I do not have management support to make a change. 4. Other: ________________________________ 8. Our accrediting body requires that we verify the time you needed to complete the 1.2 continuing education contact hour (72-minute) program: _________________________________ ! AORN, Inc, 2013