Skin Flora Bacterial Reduction Post-product Application Clinical Trial
Official title:
Assessment of the Antimicrobial Efficacy of 3M CHG/IPA Preoperative Skin Preparation Against Resident Human Skin Flora on the Abdominal and Inguinal Regions
The purpose of this study is to evaluate the antimicrobial efficacy of the 3M CHG/IPA Prep on skin flora of the abdominal and inguinal regions of human subjects.
The primary efficacy is evaluated by demonstration that the product provides a lower bound of the 95% confidence interval of percent responders that is greater than or equal to 70%. On the abdominal sites, a responder is defined as a subject with a 2-log10 per cm2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at 6 hours. On the inguinal sites, a responder is defined as a subject with a 3-log10 per cm2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at 6 hours. ;