The purpose of this study is to evaluate the safety and effectiveness of a topical antiseptic for preoperative skin preparation
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
145
BioScience Laboratories
Butte, Montana, United States
Percentage of Abdominal Site Responder Rates at 10 Minutes
Individual anatomical sites were considered responders based on the standards set forth in the Food and Drug Administration Tentative Final Monograph for Effectiveness Testing of a Patient Preoperative Skin Preparation (FR 59:116, 17 June 94, pp. 31450-31452). Individually treated abdomen sites with a 2 log10/cm\^2 CFU reduction were considered "responders," and individually treated groin sites with a 3 log10/cm\^2 CFU reduction were considered "responders."
Time frame: 10 min
Percentage of Abdominal Site Responder Rates at 6 Hours
Individual anatomical sites were considered responders based on the standards set forth in the Food and Drug Administration Tentative Final Monograph for Effectiveness Testing of a Patient Preoperative Skin Preparation (FR 59:116, 17 June 94, pp. 31450-31452). Individually treated abdomen sites with a log10/cm\^2 CFU reduction greater than or equal to 0 were considered responders.
Time frame: 6 hours
Percentage of Groin Site Responder Rate at 6 Hours
Individual anatomical sites were considered responders based on the standards set forth in the Food and Drug Administration Tentative Final Monograph for Effectiveness Testing of a Patient Preoperative Skin Preparation (FR 59:116, 17 June 94, pp. 31450-31452). Individually treated groin sites with a log10/cm\^2 CFU reduction greater than or equal to 0 were considered responders.
Time frame: 6 hours
Percentage of Groin Sites Responder Rates at 10 Minutes
Participants were considered responders based on the standards set forth in the Food and Drug Administration Tentative Final Monograph for Effectiveness Testing of a Patient Preoperative Skin Preparation (FR 59:116, 17 June 94, pp. 31450-31452). Individually treated groin sites with a 3 log10/cm\^2 CFU reduction were considered "responders."
Time frame: 10 minutes
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