The purpose of this study is to determine 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
426
Microbiotest
Sterling, Virginia, 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. 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.
Time frame: baseline, 10 minutes post-product application and 6 hour post-product application
Reduction of Skin Flora 6 Hours Post-treatment
log10/cm2 reduction of skin flora, relative to treatment day baseline (log10/cm2), at 6 hours post-treatment
Time frame: 6 hours
Reduction of Skin Flora 10 Minutes Post-treatment
log10/cm2 reduction of skin flora, relative to treatment day baseline (log10/cm2), at 10 minutes post-treatment
Time frame: 10 minutes
Skin Flora Recovery 6-hours Post-treatment
Log10/cm2 recovery of skin flora at 6 hours following application of study treatment
Time frame: 6 hours post-treatment
Skin Flora Recovery 10 Minutes Post-treatment
Log10/cm2 recovery of skin flora at 10 minutes following application of study treatments
Time frame: 10 minutes post-treatment
Skin Flora Baseline for the Abdominal and Inguinal Region.
Log10/cm2 baseline skin flora for abdominal and inguinal regions
Time frame: Baseline
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
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Apply topically
Skin irritation (dryness, edema, erythema, rash) assessed on the test sites using a 0-3 rating scale: 0=no reaction, 1=mild, 2=moderated, 3=severe
Time frame: Assessed at baseline (pre-treatment) and 10 minute post-treatment and 6 hour post-treatment.