Conditions: Bacterial Reduction on Skin Flora Post-product Application
Keywords: surgical prep CHG IPA
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 426
Healthy volunteers: yes

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes. arm 2: Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes. arm 3: Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes. arm 4: Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.

Interventions: intervention 1: ChloraPrep Hi-Lite Orange intervention 2: Normal saline intervention 3: 3M CHG/IPA Prep Tint 10.5-mL intervention 4: 3M CHG/IPA Prep Tint 26-mL
Intervention descriptions: intervention 1: Apply topically. intervention 2: Apply topically. intervention 3: Apply topically. intervention 4: Apply topically

Protocol document: