Evaluation of a waterless, scrubless chlorhexidine gluconate/ethanol surgical scrub for antimicrobial efficacy.
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).
Mulberrry
G
G
Hill Top Research, Inc., Miamiville, Ohio 45147, USA.
Snyder
A T
AT
Heilman
J
J
Pyrek
J
J
Stahl
J
J
D000328:Adult; D000891:Anti-Infective Agents, Local / Q000494:pharmacology*; D002710:Chlorhexidine / Q000031:analogs & derivatives* / Q000494:pharmacology*; D004338:Drug Combinations; D000431:Ethanol / Q000494:pharmacology*; D005260:Female; D006235:Hand Disinfection / Q000379:methods*; D006801:Humans; D008297:Male; D008826:Microbial Sensitivity Tests; D008875:Middle Aged
D000891:Anti-Infective Agents, Local; D004338:Drug Combinations; D000431:Ethanol; C010882:chlorhexidine gluconate; D002710:Chlorhexidine