Assessment of the Antimicrobial Efficacy of 3M CHG/IPA Preoperative Skin Preparation Against Resident Human Skin Flora on the Abdominal and Inguinal Regions

NCT02203591 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	3M
Phase	Phase 3
Status	COMPLETED
Enrolment	738
Start date	2014-07
Completion	2015-03

Conditions

• Bacterial Reduction Post-product Application

Interventions

• 3M CHG/IPA Prep C
• 3M CHG/IPA Prep CH
• ChloraPrep
• Normal Saline

Primary outcomes

• Responder Rate — baseline, 10 minutes post-product application and 6 hours post-product application
  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.
• Alternative Primary — Baseline and 10 minutes
  10 minute log reduction

Countries

United States