The objective of this study is to demonstrate 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 site, a responder is defined as a subject with a 2-log10/cm2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at 6 hours. On the inguinal site, a responder is defined as a subject with a 3-log10/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
738
Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.
Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.
Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.
BioScience Laboratories, Inc.
Bozeman, Montana, United States
Responder Rate
On the abdominal region a responder is a subject with a 2 log10/cm\^2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at the 6-hour sample collection time. On the inguinal region a responder is a subject with a 3 log10/cm\^2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at the 6-hour sample collection time.
Time frame: baseline, 10 minutes post-product application and 6 hours post-product application
Alternative Primary
10 minute log reduction
Time frame: Baseline and 10 minutes
Reduction of Skin Flora 6 Hours Post-treatment
Log10/cm\^2 reduction of skin flora, relative to treatment day baseline, 6 hours post-treatment application
Time frame: 6 hours
Reduction of Skin Flora 10 Minutes Post-treatment
Log10/cm\^2 reduction of skin flora, relative to treatment day baseline (log10/cm\^2) at 10 minutes post-treatment application
Time frame: 10 minutes
Skin Flora Recovery 6-hours Post-treatment
Log10/cm\^2 recovery of skin flora at 6 hours following application of treatment
Time frame: 6 hours post-treatment
Skin Flora Recovery 10 Minutes Post-treatment
Log10/cm\^2 recovery of skin flora at 10 minutes following application of study treatments.
Time frame: 10 minute post-product application
Skin Flora Baseline for the Abdomen and Inguinal Region.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.
Log10/cm\^2 baseline skin flora for abdominal and inguinal regions
Time frame: Baseline
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
Skin irritation (dryness, edema, erythema, rash) assessed on the test sites using a 0-3 rating scale; 0 = no reaction, 1 = mild, 2 = moderate, 3 = severe.
Time frame: Baseline
Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
Skin irritation (dryness, edema, erythema, rash) assessed on the test sites using a 0-3 rating scale; 0=no reaction, 1=mild, 2=moderate, 3=severe
Time frame: 10 minutes post-treatment
Safety as Assessed by Skin Irritation Score
Skin irritation rating (0-3) scores for dryness, edema, erythema and rash; 0 = no reaction, 1 = mild, 2 = moderate, 3 = severe.
Time frame: 6 hours post-treatment