| Evaluation of a waterless, scrubless chlorhexidine gluconate/ethanol surgical scrub for antimicrobial efficacy. | |
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MedLine Citation:
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PMID: 11743484 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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A new waterless surgical hand preparation containing 1% chlorhexidine gluconate (CHG) and 61% ethyl alcohol was evaluated for antimicrobial efficacy in comparison with a standard 4% CHG surgical scrub and a 61% ethyl alcohol control. Clinical studies were based on the Tentative Final Monograph for Health-Care Antiseptic Drug Products (TFM) (proposed rule) and the Standard Test Method for Evaluation of Surgical Hand Scrub Formulations (ASTM E1115-91). Two randomized, blinded, well-controlled clinical studies involving 137 healthy subjects were conducted to evaluate the antimicrobial effectiveness of the CHG/ethanol hand preparation in producing an immediate and persistent reduction in the normal bacterial flora of the hands. The CHG/ethanol hand preparation was applied without scrubbing or the use of water, and a standard 4% CHG reference product was applied with a scrub brush in 2 traditional 3-minute surgical scrubs. In 1 study, a 61% ethanol vehicle control treatment was applied without scrubbing or use of water. During a 5-day period, each study subject performed a series of 11 surgical scrubs with 1 of the test treatments. After the first treatment on days 1, 2, and 5, surgical gloves were worn for 3 or 6 hours. Bacterial samples were taken with the glove-juice technique at 1 minute, 3 hours, and 6 hours after treatment. The immediate bactericidal effect of the CHG/ethanol hand preparation after a single application resulted in a 2.5-log reduction in normal flora. This bactericidal effect persisted throughout the studies and eventually increased to a 3.6-log reduction after the 11th scrub on day 5. The log reductions of the CHG/ethanol hand preparation proved to be significantly better (P <.05) than that of the 4% CHG product at each sampling interval on days 1 and 2 and the sampling at 6 hours on day 5 and significantly better than the 61% ethanol vehicle at all times. The combination of 1% CHG and 61% ethanol had significantly greater microbial reduction than either the 4% CHG (without ethanol) or the 61% ethanol vehicle (without CHG). |
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Authors:
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G Mulberrry; A T Snyder; J Heilman; J Pyrek; J Stahl |
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Publication Detail:
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Type: Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: American journal of infection control Volume: 29 ISSN: 0196-6553 ISO Abbreviation: Am J Infect Control Publication Date: 2001 Dec |
Date Detail:
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Created Date: 2001-12-14 Completed Date: 2002-01-15 Revised Date: 2009-11-03 |
Medline Journal Info:
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Nlm Unique ID: 8004854 Medline TA: Am J Infect Control Country: United States |
Other Details:
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Languages: eng Pagination: 377-82 Citation Subset: IM |
Affiliation:
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Hill Top Research, Inc., Miamiville, Ohio 45147, USA. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adult Anti-Infective Agents, Local / pharmacology* Chlorhexidine / analogs & derivatives*, pharmacology* Drug Combinations Ethanol / pharmacology* Female Handwashing / methods* Humans Male Microbial Sensitivity Tests Middle Aged |
| Chemical | |
Reg. No./Substance:
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0/Anti-Infective Agents, Local; 0/Drug Combinations; 18472-51-0/chlorhexidine gluconate; 55-56-1/Chlorhexidine; 64-17-5/Ethanol |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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