Review| Volume 95, ISSUE 2, P163-168, February 2017

Download started.


Lack of sustained efficacy for alcohol-based surgical hand rubs containing ‘residual active ingredients’ according to EN 12791

  • G. Kampf
    Corresponding author. Address: Ernst-Moritz-Arndt-Universität Greifswald, Institut für Hygiene und Umweltmedizin, Walter-Rathenau-Str. 49A, 17475 Greifswald, Germany.
    Knieler und Team GmbH, Infection Control Solutions, Hamburg, Germany

    Institute for Hygiene and Environmental Medicine, University Medicine Greifswald, Greifswald, Germany
    Search for articles by this author
  • A. Kramer
    Institute for Hygiene and Environmental Medicine, University Medicine Greifswald, Greifswald, Germany
    Search for articles by this author
  • M. Suchomel
    Institute of Hygiene and Applied Immunology, Medical University of Vienna, Vienna, Austria
    Search for articles by this author
Published:November 12, 2016DOI:


      The World Health Organization recommends the use of hand rubs with ‘sustained activity’ for surgical hand preparation. This review aims to verify whether any of the alcohol-based hand rubs containing non-volatile ‘active ingredients’ such as chlorhexidine digluconate (CHG), mecetronium ethylsulphate (MES), or ortho-phenylphenol (OPP) provides such sustained efficacy for surgical hand disinfection. Literature was searched to find studies according to EN 12791. Published data sets were analysed to verify whether any of the formulations has a superior efficacy (P<0.01) after 3h in comparison to the reference procedure. Formulations with 0.5 and 1% CHG in 70% iso-propanol or 61% ethanol were not superior after 3h. Formulations with 0.2% MES in 45% iso-propanol and 30% n-propanol were also not superior when applied for 1min (one data set), 1.5min as currently recommended for use (14 data sets), and 2min (one data set). When applied for 3min the formulations were superior in three out of seven data sets. The hand rub with 0.1% OPP in 78.2% ethanol was also not superior to the reference treatment when applied as recommended for 1.5min. It appears reasonable and responsible to limit the dermal exposure and environmental input to biocidal agents with a clear benefit such as the alcohols. In analogy to avoiding dyes and fragrances in hand rubs, formulations containing ‘active’ substances without a clear benefit but with potential risks should be avoided when alternative formulations with the same level of antimicrobial activity, dermal tolerance, and user acceptability are available.


      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'


      Subscribe to Journal of Hospital Infection
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect


        • Anonymous
        WHO guidelines on hand hygiene in health care. First Global Patient Safety Challenge. Clean Care is Safer Care.
        WHO, Geneva2009
        • Mulberry G.
        • Snyder A.T.
        • 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: 377-382
        • Kampf G.
        • Reichel M.
        • Hollingsworth A.
        • Bashir M.
        Efficacy of surgical hand scrub products based on chlorhexidine is largely overestimated without neutralizing agents in the sampling fluid.
        Am J Infect Control. 2013; 41: e1-e5
      1. EN 12791:2015. Chemical disinfectants and antiseptics. Surgical hand disinfection. Test method and requirement (phase 2, step 2). Brussels: CEN – Comité Européen de Normalisation; 2015.

        • Rotter M.L.
        • Kampf G.
        • Suchomel M.
        • Kundi M.
        Population kinetics of the skin flora on gloved hands following surgical hand disinfection with 3 propanol-based hand rubs: a prospective, randomized, double-blind trial.
        Infect Control Hosp Epidemiol. 2007; 28: 346-350
        • Kampf G.
        • Ostermeyer C.
        Efficacy of two distinct ethanol-based hand rubs for surgical hand disinfection – a controlled trial according to prEN 12791.
        BMC Infect Dis. 2005; 5: 17
        • Kampf G.
        • Ostermeyer C.
        • Heeg P.
        Surgical hand disinfection with a propanol-based hand rub: equivalence of shorter application times.
        J Hosp Infect. 2005; 59: 304-310
        • Hübner N.-O.
        • Kampf G.
        • Kamp P.
        • Kohlmann T.
        • Kramer A.
        Does a preceding hand wash and drying time after surgical hand disinfection influence the efficacy of a propanol-based hand rub?.
        BMC Microbiology. 2006; 6: 57
        • Kampf G.
        • Ostermeyer C.
        • Kohlmann T.
        Bacterial population kinetics on hands during 2 consecutive surgical hand disinfection procedures.
        Am J Infect Control. 2008; 36: 369-374
        • Kampf G.
        • Ostermeyer C.
        A 1-minute hand wash does not impair the efficacy of a propanol-based hand rub in two consecutive surgical hand disinfection procedures.
        Eur J Clin Microbiol Infect Dis. 2009; 28: 1357-1362
        • Rotter M.L.
        • Kampf G.
        • Suchomel M.
        • Kundi M.
        Long-term effect of a 1.5 minute surgical hand rub with a propanol-based product on the resident hand flora.
        J Hosp Infect. 2007; 66: 84-85
        • Kampf G.
        • Ostermeyer C.
        • Heeg P.
        • Paulson D.
        Evaluation of two methods of determining the efficacies of two alcohol-based hand rubs for surgical hand antisepsis.
        Appl Environ Microbiol. 2006; 72: 3856-3861
        • Suchomel M.
        • Gnant G.
        • Weinlich M.
        • Rotter M.
        Surgical hand disinfection using alcohol: the effects of alcohol type, mode and duration of application.
        J Hosp Infect. 2009; 71: 228-233
        • Marchetti M.G.
        • Kampf G.
        • Finzi G.
        • Salvatorelli G.
        Evaluation of the bactericidal effect of five products for surgical hand disinfection according to prEN 12054 and prEN 12791.
        J Hosp Infect. 2003; 54: 63-67
        • Barbut F.
        • Djamdjian L.
        • Neyme D.
        • Passot C.
        • Petit J.C.
        Efficacy of 2 alcohol-based gels and 1 alcohol-based rinse for surgical hand disinfection.
        Infect Control Hosp Epidemiol. 2007; 28: 1013-1015
        • Kramer A.
        Stellungnahme des Vorstands der DGKH zur chirurgischen Händedesinfektion.
        Hygiene + Medizin. 2005; 30: 117
        • Kampf G.
        • Ostermeyer C.
        Influence of applied volume on efficacy of 3-minute surgical reference disinfection method prEN 12791.
        Appl Environ Microbiol. 2004; 70: 7066-7069
        • Widmer A.F.
        • Rotter M.
        • Voss A.
        • et al.
        Surgical hand preparation: state-of-the-art.
        J Hosp Infect. 2010; 74: 112-122
        • Lachapelle J.M.
        A comparison of the irritant and allergenic properties of antiseptics.
        Eur J Dermatol. 2014; 24: 3-9
        • Tupker R.A.
        • Schuur J.
        • Coenraads P.J.
        Irritancy of antiseptics tested by repeated open exposure on the human skin, evaluated by non-invasive methods.
        Contact Dermatitis. 1997; 37: 213-217
        • Quatresooz P.
        • Xhauflaire-Uhoda E.
        • Pierard-Franchimont C.
        • Pierard G.E.
        Regional variability in stratum corneum reactivity to antiseptic formulations.
        Contact Dermatitis. 2007; 56: 271-273
        • Silvestri D.L.
        • McEnery-Stonelake M.
        Chlorhexidine: uses and adverse reactions.
        Dermatitis. 2013; 24: 112-118
        • Stingeni L.
        • Lapomarda V.
        • Lisi P.
        Occupational hand dermatitis in hospital environments.
        Contact Dermatitis. 1995; 33: 172-176
        • Kramer A.
        • Adrian V.
        • Rudolph P.
        • Wurster S.
        • Lippert H.
        Explantationstest mit Haut und Peritoneum der neonatalen Ratte als Voraussagetest zur Verträglichkeit lokaler Antiinfektiva für Wunden und Körperhöhlen.
        Der Chirurg. 1998; 69: 840-845
        • Wittczak T.
        • Dudek W.
        • Walusiak-Skorupa J.
        • Swierczynska-Machura D.
        • Palczynski C.
        Chlorhexidine – still an underestimated allergic hazard for health care professionals.
        Occup Med (Lond). 2013; 63: 301-305
        • Liippo J.
        • Kousa P.
        • Lammintausta K.
        The relevance of chlorhexidine contact allergy.
        Contact Dermatitis. 2011; 64: 229-234
        • Hong C.C.
        • Wang S.M.
        • Nather A.
        • Tan J.H.
        • Tay S.H.
        • Poon K.H.
        Chlorhexidine anaphylaxis masquerading as septic shock.
        Int Arch Allergy Immunol. 2015; 167: 16-20
        • Odedra K.M.
        • Farooque S.
        Chlorhexidine: an unrecognised cause of anaphylaxis.
        Postgrad Med J. 2014; 90: 709-714
        • Ohtoshi T.
        • Yamauchi N.
        • Tadokoro K.
        • et al.
        IgE antibody-mediated shock reaction caused by topical application of chlorhexidine.
        Clin Allergy. 1986; 16: 155-161
        • Waclawski E.R.
        • McAlpine L.G.
        • Thomson N.C.
        Occupational asthma in nurses caused by chlorhexidine and alcohol aerosols.
        BMJ (Clin Res Ed). 1989; 298: 929-930
        • Nagendran V.
        • Wicking J.
        • Ekbote A.
        • Onyekwe T.
        • Garvey L.H.
        IgE-mediated chlorhexidine allergy: a new occupational hazard?.
        Occup Med (Lond). 2009; 59: 270-272
        • Cimiotti J.P.
        • Marmur E.S.
        • Nesin M.
        • Hamlin-Cook P.
        • Larson E.L.
        Adverse reactions associated with an alcohol-based hand antiseptic among nurses in a neonatal intensive care unit.
        Am J Infect Control. 2003; 31: 43-48
        • Pham N.H.
        • Weiner J.M.
        • Reisner G.S.
        • Baldo B.A.
        Anaphylaxis to chlorhexidine. Case report. Implication of immunoglobulin e antibodies and identification of an allergenic determinant.
        Clin Exposure Allergy. 2000; 30: 1001-1007
        • Nakonechna A.
        • Dore P.
        • Dixon T.
        • et al.
        Immediate hypersensitivity to chlorhexidine is increasingly recognised in the United Kingdom.
        Allergol Immunopathol (Madr). 2014; 42: 44-49
        • Beaudouin E.
        • Kanny G.
        • Morisset M.
        • et al.
        Immediate hypersensitivity to chlorhexidine: literature review.
        Eur Ann Allergy Clin Immunol. 2004; 36: 123-126
        • Supapvanich C.
        • Povey A.C.
        • de Vocht F.
        Respiratory and dermal symptoms in Thai nurses using latex products.
        Occup Med (Lond). 2013; 63: 425-428
        • Sato K.
        • Kusaka Y.
        • Suganuma N.
        • Nagasawa S.
        • Deguchi Y.
        Occupational allergy in medical doctors.
        J Occupat Health. 2004; 46: 165-170
        • Rudzki E.
        • Rebandel P.
        • Grzywa Z.
        Patch tests with occupational contactants in nurses, doctors and dentists.
        Contact Dermatitis. 1989; 20: 247-250
        • Toholka R.
        • Nixon R.
        Allergic contact dermatitis to chlorhexidine.
        Austral J Dermatol. 2013; 54: 303-306
        • Apisarnthanarak A.
        • Mundy L.M.
        High incidence of chlorhexidine-induced rash among Thai health care workers.
        Clin Infect Dis. 2011; 53: 848-849
        • Hall T.J.
        • Wren M.W.
        • Jeanes A.
        • Gant V.A.
        A comparison of the antibacterial efficacy and cytotoxicity to cultured human skin cells of 7 commercial hand rubs and Xgel, a new copper-based biocidal hand rub.
        Am J Infect Control. 2009; 37: 322-326
        • Proske O.
        • Sauermann G.
        • Pietsch H.
        • Rohde B.
        Die Hautverträglichkeit von Mecetroniumetilsulfat in einem Desinfektionsmittel – eine klinische Studie.
        Hygiene + Medizin. 1995; 20: 535-542
        • Kampf G.
        • Muscatiello M.
        Dermal tolerance of Sterillium, a propanol-based hand rub.
        J Hosp Infect. 2003; 55: 295-298
        • Kampf G.
        • Wigger-Alberti W.
        • Wilhelm K.P.
        Do atopics tolerate alcohol-based hand rubs? A prospective, controlled, randomized double-blind clinical trial.
        Acta Derm Vener. 2006; 86: 140-143
        • Kampf G.
        • Wigger-Alberti W.
        • Schoder V.
        • Wilhelm K.P.
        Emollients in a propanol-based hand rub can significantly decrease irritant contact dermatitis.
        Contact Dermatitis. 2005; 53: 344-349
        • Kappes U.P.
        • Goritz N.
        • Wigger-Alberti W.
        • Heinemann C.
        • Elsner P.
        Tandem application of sodium lauryl sulfate and n-propanol does not lead to enhancement of cumulative skin irritation.
        Acta Derm Venereol. 2001; 81: 403-405
        • Wigger-Alberti W.
        • Krebs A.
        • Elsner P.
        Experimental irritant contact dermatitis due to cumulative epicutaneous exposure to sodium lauryl sulphate and toluene: single and concurrent application.
        Br J Dermatol. 2000; 143: 551-556
        • Slotosch C.M.
        • Kampf G.
        • Löffler H.
        Effects of disinfectants and detergents on skin irritation.
        Contact Dermatitis. 2007; 57: 235-241
        • Meyer B.
        • Cookson B.
        Does microbial resistance or adaptation to biocides create a hazard in infection prevention and control?.
        J Hosp Infect. 2010; 76: 200-205
        • Kampf G.
        Acquired resistance to chlorhexidine – is it time to establish an “antiseptic stewardship” initiative?.
        J Hosp Infect. 2016; 94: 213-227
        • Farrand R.J.
        • Williams A.
        Evaluation of single-use packs of hospital disinfectants.
        Lancet. 1973; 1: 591-593
        • Levy S.B.
        Active efflux, a common mechanism for biocide and antibiotic resistance.
        J Appl Microbiol. 2002; 92: 65s-71s
        • Kaulfers P.-M.
        Epidemiologie und Ursachen mikrobieller Biozidresistenzen.
        Zentralblatt für Hygiene und Umweltmedizin. 1995; 197: 252-259
        • Hingst V.
        • Klippel K.M.
        • Sonntag H.-G.
        Untersuchungen zur Epidemiologie mikrobieller Biozidresistenzen.
        Zentralblatt für Hygiene und Umweltmedizin. 1995; 197: 232-251
        • Russell A.D.
        Plasmids and bacterial resistance to biocides.
        J Appl Microbiol. 1997; 83: 155-165
        • Weber D.J.
        • Rutala W.A.
        • Sickbert-Bennett E.E.
        Outbreaks associated with contaminated antiseptics and disinfectants.
        Antimicrob Agents Chemother. 2007; 51: 4217-4224
        • Schubert S.
        • Bauer A.
        • Molin S.
        • Skudlik C.
        • Geier J.
        Occupational contact sensitization in female geriatric nurses: data of the Information Network of Departments of Dermatology (IVDK) 2005–2014.
        J Eur Acad Dermatol Venereol. 2016 Aug 12; ([Epub ahead of print])
      2. Aktion Saubere Hände. 2010. Available at: http://wwwaktion-sauberehaendede/fileadmin/ash/downloads/pdf/ASH_Positionspapier_Hautschutz_Hautpflege_Farb-Paruemfrei_112010pdf [last accessed November 2016].

        • KRINKO am Robert Koch Institut
        Händehygiene in Einrichtungen des Gesundheitswesens.
        Bundesgesundheitsblatt. 2016; 59: 1189-1220