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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
171
BioScience Laboratories, Inc.
Bozeman, Montana, United States
Responder Rate
On the abdominal region a responder was a subject with a 2-log10/cm2 bacterial reduction at 10 minutes and for whom the skin flora did not return to baseline at 6 hours. On the inguinal region a responder was a subject with a 3-log10/cm2 bacterial reduction at 10 minutes and for whom the skin flora did not return to baseline at 6 hours.
Time frame: baseline, 10 minute post-product application and 6 hour post-product application
Skin Flora Baseline for Abdominal and Inguinal Regions
Log10/cm2 baseline skin flora for abdominal and inguinal regions
Time frame: Baseline
Skin Flora Recovery Post-treatment
Log10/cm2 recovery of skin flora at 10 minutes and 6 hours following application of study treatments for abdominal and inguinal regions
Time frame: 10 minutes and 6 hours post-treatment
Reduction of Skin Flora Post-treatment
Log10/cm2 reduction of skin flora, relative to Treatment Day baseline log10/cm2, at 10 minutes and 6 hours
Time frame: Baseline, 10 minutes and 6 hours
Safety as Assessed by Skin Irritation Scores
Skin irritation rating (0-3) scores for dryness, edema, erythema and rash. 0 = no reaction, 1 = mild, 2 = moderate, 3 = severe. A skin irritation rating of 3 in any category represents significant irritation and qualifies as an adverse event.
Time frame: Baseline
Safety as Assessed by Skin Irritation Scores
Skin irritation rating (0-3) scores for dryness, edema, erythema and rash. 0 = no reaction, 1 = mild, 2 = moderate, 3 = severe. A skin irritation rating of 3 in any category represents significant irritation and qualifies as an adverse event.
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Apply topically.
Time frame: 10 minutes post-treatment
Safety as Assessed by Skin Irritation Scores
Skin irritation rating (0-3) scores for dryness, edema, erythema and rash. 0 = no reaction, 1 = mild, 2 = moderate, 3 = severe. A skin irritation rating of 3 in any category represents significant irritation and qualifies as an adverse event.
Time frame: 6 hours post-treatment