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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 b Department of Biomedical Sciences and Public Health, Unit of Hygiene, Preventive Medicine and Public Health, Universita`Politecnica delle Marche, Ancona, Italy A RT 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 SUMM ARY 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%; N- propyl alcohol 25%; glycerin 1.74%; triethanolamine salt of carbomer <1%) was compared with other widely used products in surgical hand antisepsis (chlorhexidine and povidone- iodine). 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 log 10 compared with 2.86 1.22 log 10 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 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 How- ever, recently there has been a growing interest in challenging surgical handwashing procedure in real working settings, and * Corresponding author. Address: Dipartimento di Scienze Bio- mediche e Sanita ` Pubblica, Universita ` 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). Available online at www.sciencedirect.com Journal of Hospital Infection journal homepage: www.elsevierhealth.com/journals/jhin 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 Journal of Hospital Infection 86 (2014) 64e67

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  • ww.sciencedirect.com

    Journal of Hospital Infection 86 (2014) 64e67Available online at wJournal of Hospital Infection

    journal homepage: www.elsevierhealth.com/journals / jh inIn vivo comparative efficacy of three surgical handpreparation 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. DErrico a,b

    aHospital Hygiene Service, Ospedali Riuniti, Ancona, ItalybDepartment of Biomedical Sciences and Public Health, Unit of Hygiene, Preventive Medicine and Public Health,Universita Politecnica delle Marche, Ancona, ItalyA R T I C L E I N F O

    Article history:Received 18 June 2013Accepted 23 September 2013Available online 16 October2013

    Keywords:Alcohol-based hand rubAntisepticsEfficacySurgical hand hygiene* Corresponding author. Address: Dipartimediche e Sanita Pubblica, Universita PoliteTronto 10/a, 60020 Torrette di Ancona, Italyfax: 39 0712206032.

    E-mail address: [email protected] (E.

    0195-6701/$ e see front matter 2013 Thehttp://dx.doi.org/10.1016/j.jhin.2013.09.013S U M M A R Y

    Background: Besides objective efficacy, the choice between an antiseptic-based liquidsoap, or an alcohol-based hand rub for surgical hand preparation technique is based onpersonal preference. Glycerol is often added to the formulations in order to enhancetolerability; however, it has been recently reported as a factor reducing the sustainedeffect 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%; N-propyl alcohol 25%; glycerin 1.74%; triethanolamine salt of carbomer

  • P. Barbadoro et al. / Journal of Hospital Infection 86 (2014) 64e67 65the formulations recommended by the World Health Organi-zation have been discussed.8e10 Moreover, the glycerolcomponent of alcohol-based hand rub has been recently eval-uated as a factor reducing the sustained effect of surgical handrubs.11

    The objective of this work was to compare the in vivo effi-cacy of an alcohol formulation with respect to other widelyused products in surgical hand antisepsis.Methods

    Products tested

    The tested products were based on the following formula-tions: (i) chlorhexidine (chlorhexidine gluconate 4%; propan-2-ol 1e5%; lauryldimethylamine oxide 1e5%; glycerol 1e5%); (ii)povidone-iodine (7.5%); and (iii) an alcohol formulation (iso-propyl alcohol 40%; N-propyl alcohol 25%; glycerin 1.74%;triethanolamine salt of carbomer

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    Alcohol Chlorhexidine Povidone-iodine

    Figure 2. Box plot showing sustained effect (reduction factorwith respect to plain soap after 3 h) of different agents.

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    Alcohol Chlorhexidine Povidone-iodine

    Figure 1. Box plot showing immediate effect (reduction factorwith respect to plain soap) of different agents.

    P. Barbadoro et al. / Journal of Hospital Infection 86 (2014) 64e6766On the hands of 35% (7/20) of volunteers, small sticky ag-glomerates appeared, presumably formed by the reaction be-tween flaking skin cells and the glycerol of the alcohol hand rubwhile performing hand hygiene with alcohol-based hand rub.We have defined this phenomenon as skin peeling. In partici-pants experiencing this phenomenon, the RF for the sustainedeffect was significantly lower than that registered for the im-mediate effect (1.06 0.47 log10 vs 2.48 1.24 log10 withrespect to the group who did not show this phenomenon,P < 0.05). This difference was not significant in participantswho did not experience the skin peeling (with immediate RF of2.16 1.82 log10 vs 2.37 1.71 log10 of RF for sustained effect,P > 0.05).

    Discussion

    Our main finding is that significant differences under prac-tical conditions were observed in vivo for products currentlyused in surgical hand preparation. The best results were ach-ieved with the alcohol-based hand rub. This is not surprising astheir efficacy in the preoperative treatment of hands is wellknown; nevertheless many professionals involved in surgicalprocedures remain reluctant to switch from an antiseptic soapto an alcohol-based hand rub.12 Moreover, Tanner et al. haveconcluded that the quality of the sum of the evidenceregarding alcohol hand rub use for surgical hand preparation isvariable and that the effects on the outcome, when consideringsurgical site infections, is mixed.1

    The excellent immediate effect may also be enhanced bythe presence of excipients, that have been shown to beimportant.9 However, we also note the paradoxical effectshown in vivo in volunteers with self-reported skin peeling,Table I

    Difference between reduction factor, pairwise comparison ofproduct for immediate effect

    Alcohol Chlorhexidine

    Chlorhexidine 1.33a

    Povidone-iodine 2.11a 0.78a

    a P < 0.05 (analysis of variance).resulting in a higher number of cfu measured at 48 h comparedwith volunteers without skin peeling. In our opinion, such handrubs may cause the formation of small agglomerates in selectedusers which feel like gritty particles on the hands (skinpeeling). This effect has already been described in associationwith the use of powdered gloves, but in this trial this effect wasnot related to use of powdered gloves, since it was noted afterhand disinfection and before glove use.3 This finding may sug-gest that the substantially reduced effect of alcohol-basedhand rub, in selected participants, may be associated withthe glycerol content of the gel, as has been recently reported,and may also be responsible for the gritty particles noted bysome participants.11 We agree with Suchomel et al., whodiscuss the possible role of glycerol in producing a moisterenvironment under surgical gloves, thus supporting the multi-plication of residual skin flora and drawing bacterial flora fromdeeper skin layers. In accordance with the Guideline for HandHygiene in Health-Care Settings, we may suggest switching toan alternative product, or using hand washing after disinfec-tion with alcohol products for these professionals.3,11 Furtherstudies are needed to investigate the interactions between skinflora and the glycerol content of the alcohol hand rub. More-over, we must underline that a modified version of the abovehand rub has been adopted in other countries, but is notlicensed in Italy, where only the above-tested product isavailable.

    In conclusion, our experience confirms the importance ofalcohol-based hand rubs for the surgical decontamination ofhands. Moreover, our results highlight the value of assessing thecharacteristics, and response of healthcare workers skin, thatmay contribute to the development of clumps which maycontribute to a paradoxical overcolonization 3 h after surgicalTable II

    Difference between reduction factor, pairwise comparison ofproduct for sustained effect

    Alcohol Chlorhexidine

    Chlorhexidine 1.09a

    Povidone-iodine 1.39a 0.30a

    a P < 0.05 (analysis of variance).

  • P. Barbadoro et al. / Journal of Hospital Infection 86 (2014) 64e67 67hand decontamination with alcohol-based hand rubs containingglycerol. These results underline the need to obtain a morepowerful, yet tolerable, hand solution in order to overcomebarriers to utilization, side-effects, and to improve hand hy-giene behaviour.

    Conflict of interest statementNone declared.

    Funding sourcesNone.

    References

    1. Tanner J, Swarbrook S, Stuart J. Surgical hand antisepsis to reducesurgical site infection. Cochrane Database Syst Rev2008;(1):CD004288.

    2. Dudeck MA, Horan TC, Peterson KD, et al. National HealthcareSafety Network (NHSN) Report, data summary for 2010, device-associated module. Am J Infect Control 2011;39:798e816.

    3. Boyce JM, Pittet D, Healthcare Infection Control Practices AdvisoryCommittee, et al. Guideline for Hand Hygiene in Health-Care Set-tings: recommendations of the Healthcare Infection Control Prac-tices Advisory Committee and the HICPAC/SHEA/APIC/IDSA HandHygiene Task Force. Infect Control Hosp Epidemiol 2002;23:S3eS40.

    4. Pittet D, Allegranzi B, Boyce J, World Health Organization WorldAlliance for Patient Safety First Global Patient Safety ChallengeCore Group of Experts. The World Health Organization Guidelineson Hand Hygiene in Health Care and their consensus recommen-dations. Infect Control Hosp Epidemiol 2009;30:611e622.5. European Norm (EN) 12054. Chemical disinfectants and antisep-tics. Quantitative suspension test for the evaluation of bacteri-cidal activity of products for hygienic and surgical hand rub andhand wash used in human medicine. Test method and re-quirements (Phase 2/Step 1). Brussels: Comite Europeen de Nor-malisation; 2001.

    6. European Norm (EN) 12791. Chemical disinfectants and anti-septics e surgical hand disinfection. Test method and re-quirements (Phase 2/Step 2). Brussels: Comite Europeen deNormalisation; 2005.

    7. Labadie J-C, Kampf G, Lejeune B, et al. Recommendation forsurgical hand disinfection requirements, implementation and needfor research. A proposal by representatives of the SFHH, DGHMand DGKH for a European discussion. J Hosp Infect 2002;51:312e315.

    8. Suchomel M, Kundi M, Allegranzi B, Pittet D, Rotter ML. Testing ofthe World Health Organization-recommended formulations forsurgical hand preparation and proposals for increased efficacy.J Hosp Infect 2011;79:115e118.

    9. Edmonds SL, Macinga DR, Mays-Suko P, et al. Comparative efficacyof commercially available alcohol-based hand rubs and WorldHealth Organization-recommended hand rubs: formulation mat-ters. Am J Infect Control 2012;40:521e525.

    10. Kampf G, Ostermeyer C. WHO-recommended hand-rub formula-tions do not meet European efficacy requirements for surgicalhand disinfection in 5 minutes. J Hosp Infect 2011;78:123e127.

    11. Suchomel M, Rotter M, Weinlich M, Kundi M. Glycerol significantlydecreases the three hour efficacy of alcohol-based surgical handrubs. J Hosp Infect 2013;83:284e287.

    12. Rotter ML. Arguments for alcoholic hand disinfection. J HospInfect 2001;48(Suppl. A):S4eS8.

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    In vivo comparative efficacy of three surgical hand preparation agents in reducing bacterial countIntroductionMethodsProducts testedWash phase (pre-values)Surgical preparation phaseDetermination of post valuesData analysis

    ResultsDiscussionConflict of interest statementFunding sourcesReferences