Document Detail

Evaluation of a waterless, scrubless chlorhexidine gluconate/ethanol surgical scrub for antimicrobial efficacy.
MedLine Citation:
PMID:  11743484     Owner:  NLM     Status:  MEDLINE    
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).
G Mulberrry; A T Snyder; J Heilman; J Pyrek; J Stahl
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Publication Detail:
Type:  Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  American journal of infection control     Volume:  29     ISSN:  0196-6553     ISO Abbreviation:  Am J Infect Control     Publication Date:  2001 Dec 
Date Detail:
Created Date:  2001-12-14     Completed Date:  2002-01-15     Revised Date:  2013-05-29    
Medline Journal Info:
Nlm Unique ID:  8004854     Medline TA:  Am J Infect Control     Country:  United States    
Other Details:
Languages:  eng     Pagination:  377-82     Citation Subset:  IM    
Hill Top Research, Inc., Miamiville, Ohio 45147, USA.
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MeSH Terms
Anti-Infective Agents, Local / pharmacology*
Chlorhexidine / analogs & derivatives*,  pharmacology*
Drug Combinations
Ethanol / pharmacology*
Hand Disinfection / methods*
Microbial Sensitivity Tests
Middle Aged
Reg. No./Substance:
0/Anti-Infective Agents, Local; 0/Drug Combinations; 55-56-1/Chlorhexidine; 64-17-5/Ethanol; MOR84MUD8E/chlorhexidine gluconate

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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