Hostname: page-component-78c5997874-s2hrs Total loading time: 0 Render date: 2024-11-02T20:29:05.615Z Has data issue: false hasContentIssue false

Evaluation of an Alcohol-Based Surgical Hand Disinfectant Containing a Synergistic Combination of Farnesol and Benzethonium Chloride for Immediate and Persistent Activity Against Resident Hand Flora of Volunteers and With a Novel In Vitro Pig Skin Model

Published online by Cambridge University Press:  02 January 2015

Milind S. Shintre
Affiliation:
College of Physicians and Surgeons of Columbia University, New York, New York
Trupti A. Gaonkar
Affiliation:
College of Physicians and Surgeons of Columbia University, New York, New York
Shanta M. Modak*
Affiliation:
College of Physicians and Surgeons of Columbia University, New York, New York
*
Columbia University, College of Physicians and Surgeons, 17-401C, 630 West 168th Street, New York, NY 10032 ([email protected])

Abstract

Objective.

To evaluate the immediate, persistent and sustained in vivo activity of an alcohol-based surgical hand disinfectant, consisting of a zinc gel and a preservative system containing a synergistic combination of farnesol and benzethonium chloride (ZBF disinfectant), and to develop a pig skin model for in vitro evaluation of the immediate and persistent efficacy of alcohol-based surgical hand disinfectants against resident hand flora.

Design.

The in vivo immediate, persistent, and sustained activity of ZBF disinfectant was evaluated using human volunteers and the “glove-juice” method described in the US Food and Drug Administration's Tentative Final Monograph (FDA-TFM) for Healthcare Antiseptic Products. A novel in vitro pig skin model was developed to compare the immediate and persistent activity of alcohol-based surgical hand disinfectants against resident flora using Staphylococcus epidermidis as the test organism. Four alcohol-based surgical hand disinfectants were evaluated using this model.

Results.

The results for the ZBF disinfectant exceed the FDA-TFM criteria for immediate, persistent, and sustained activity required for surgical hand disinfectants. The reduction factors for the 4 hand disinfectants obtained using the pig skin model show good agreement with the log10 reductions in concentrations of hand flora obtained using human volunteers to test for immediate and persistent activity.

Conclusion.

The ZBF disinfectant we evaluated met the FDA-TFM criteria for surgical hand disinfectants. The immediate and persistent efficacy of the surgical hand disinfectants evaluated with the novel pig skin model described in this study shows good agreement with the results obtained in vivo.

Type
Original Articles
Copyright
Copyright © The Society for Healthcare Epidemiology of America 2007

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

1.Boyce, JM, Pittet, D. 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;51:145.Google Scholar
2.Larson, EL, Aiello, AE, Heilman, JM, et al. Comparison of different regimens for surgical hand preparation. AORN J 2001;73:412432.CrossRefGoogle ScholarPubMed
3.Bryce, EA, Spence, D, Roberts, FJ. An in-use evaluation of an alcohol-based pre-surgical hand disinfectant. Infect Control Hosp Epidemiol; 2001;22:635639.Google Scholar
4.Hilburn, J, Hammond, BS, Fendler, EJ, Groziak, PA. Use of alcohol hand sanitizer as an infection control strategy in an acute care facility. Am J Infect Control 2003;31:109116.Google Scholar
5.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;29:377382.CrossRefGoogle ScholarPubMed
6.Hobson, DW, Woller, W, Anderson, L, Guthery, E. Development and evaluation of a new alcohol-based surgical hand scrub formulation with persistent antimicrobial characteristics and brushless application. Am J Infect Control 1998;26:507512.Google Scholar
7.Guthery, E, Seal, LA, Anderson, EL. Zinc pyrithione in alcohol-based products for skin antisepsis: persistence of antimicrobial effects. Am J Infect Control 2005;33:1522.Google Scholar
8.Wong, WK, Goh, CL, Chan, KW. Contact urticaria from Chlorhexidine. Contact Dermatitis 1990;22:52.Google Scholar
9.Autegarden, JE, Pecquet, C, Huet, S, Bayrou, O, Leynadier, F. Anaphylactic shock after application of Chlorhexidine to unbroken skin. Contact Dermatitis 1999;40:215.Google Scholar
10.Knight, BA, Puy, R, Douglass, J, O'Hehir, RE, Thien, F. Chlorhexidine anaphylaxis: a case report and review of the literature. Intern Med J 2001;31:436437.Google Scholar
11.Perrenoud, D, Bircher, A, Hunziker, T, et al. Frequency of sensitization to 13 common preservatives in Switzerland. Swiss Contact Dermatitis Research Group. Contact Dermatitis 1994;30:276279.CrossRefGoogle ScholarPubMed
12.Torricelli, R, Wuthrich, B. Life-threatening anaphylactic shock due to skin application of Chlorhexidine. Clin Exp Allergy 1996;26:112.Google Scholar
13.Center for Drug Evaluation and Research (FDA). Avagard-CHG antiseptic hand preparation (1% Chlorhexidine gluconate, 61% ethyl alcohol). NDA: Application Number 21-074. Medical Review, 1999.Google Scholar
14.Priestley, GC, Brown, JC. Acute toxicity of zinc pyrithione to human skin cells in vitro. Acta Derm Venereol 1980;60:145148.Google Scholar
15.Gaonkar, TA, Geraldo, I, Caraos, L, Modak, SM. An alcohol hand rub containing a synergistic combination of an emollient and preservatives: prolonged activity against transient pathogens. J Hosp Infect 2005;59:1218.CrossRefGoogle ScholarPubMed
16.Modak, S, Gaonkar, TA, Shintre, M, Sampath, L, Caraos, L, Geraldo, I. A topical cream containing a zinc gel (Allergy Guard) as a prophylactic against latex glove-related contact dermatitis. Dermatitis 2005;16:2227.Google Scholar
17.United States Food and Drug Administration. Federal Register part III, tentative final monograph for health-care antiseptic drug products;proposed rule. 59, No. 116 (June 17, 1994). Code of Federal Regulations, Title 21 CFR Parts 333 and 369, 31402-31452.Google Scholar
18.Gaonkar, TA, Geraldo, I, Shintre, M, Modak, SM. In vivo efficacy of an alcohol-based surgical hand disinfectant containing synergistic combination of ethylhexylglycerine and preservatives. J Hosp Infect 2006;63:412417.Google Scholar
19.Gould, GW. Industry perspectives on the use of natural antimicrobials and inhibitors for food applications. J Food Prot 1996;59(Suppl):8286.Google Scholar
20.Cornwell, PA, Barry, BW. Sesquiterpene components of volatile oils as skin penetration enhancers for the hydrophilic permeant 5-fluorouracil. J Pharm Pharmacol 1994;46:261269.Google Scholar
21.Brehm-Stecher, BF, Johnson, EA. Sensitization of Staphylococcus aureus and Escherichia coli to antibiotics by the sesquiterpenoids nerolidol, farnesol, bisabolol, and apritone. Antimicrob Agents Chemother 2003;47:33573360.Google Scholar
22.Trampuz, A, Widmer, AF. Hand hygiene: a frequently missed lifesaving opportunity during patient care. Mayo Clin Proc 2004;79:109116.CrossRefGoogle ScholarPubMed
23.Gruendemann, BJ, Bjerke, NB. Is it time for brushless scrubbing with an alcohol-based agent? AORN J 2001;74:859873.Google Scholar
24. prEN12791. Chemical disinfectants and antiseptics. Surgical hand disinfectants: test method and requirement (phase 2, step 2). European Comittee for Standardization (ComitéEuropéen de Normalisation [CEN]), Brussels;1997.Google Scholar
25. EN 1500. Chemical disinfectants and antiseptics. Hygienic handrub: test method and requirement (phase 2, step 2). European Comittee for Standardization (ComitéEuropéen de Normalisation [CEN]), Brussels; 1997Google Scholar
26.American Society for Testing Materials. Standard test method for evaluation of the effectiveness of healthcare personnel or consumer handwash formulations. Method-E 1174; 2000:394397.Google Scholar
27.Maillard, JY, Messager, S, Veillon, R. Antimicrobial efficacy of biocides tested on skin using an ex vivo test. J Hosp Infect 1998;40:313323.Google Scholar
28.Messager, S, Goddard, PA, Dettmar, PW, Maillard, JY. Comparison of two in vivo and two ex vivo tests to assess the antibacterial activity of several antiseptics. J Hosp Infect 2004;58:115121.Google Scholar
29.Bush, LW, Benson, LM, White, JH. Pig skin as test substrate for evaluating topical antimicrobial activity. J Clin Microbiol 1986;24:343348.Google Scholar
30.Bissett, DL, McBride, JF. The use of the domestic pig as an animal model for human dry skin and for comparison of dry and normal skin properties. J Soc Cosmet Chem 1983;34:317326.Google Scholar
31.Meyer, W, Schwarz, R, Neurand, K. The skin of domestic mammals as a model for the human skin, with special reference to the domestic pig. Curr Probi Dermatol 1978;7:3952.Google Scholar
32.Dyer, DL, Gerenraich, KB, Wadhams, PS. Testing a new alcohol-free hand sanitizer to combat infection. AORN J 1998;68: 239-241, 243-244, 247251.CrossRefGoogle ScholarPubMed
33.Cimiotti, JP, Marmur, ES, Nesin, M, Hamilin-Cook, P, Larson, EL. Adverse reactions associated with an alcohol-based hand antiseptic among nurses in a neonatal intensive care unit. Am J Infect Control 2003;31:4348.Google Scholar
34.Rilliet, A, Hunziker, N, Brun, R. Alcohol contact urticaria syndrome (immediate-type hypersensitivity): case report. Dermatologica 1980;161:361364.Google Scholar