NCT01968707

In-vivo Efficacy Study of Patient Pre-operative Preps

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 426 (actual)
• Sponsor: Solventum US LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Bacterial Reduction on Skin Flora Post-product Application

Interventions

Type	Name	Description
DRUG	ChloraPrep Hi-Lite Orange	Apply topically.
DRUG	Normal saline	Apply topically.
DRUG	3M CHG/IPA Prep Tint 10.5-mL	Apply topically.
DRUG	3M CHG/IPA Prep Tint 26-mL	Apply topically

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2013-10-24
• Last updated: 2024-10-02
• Results posted: 2021-06-09

Locations

1 site across 1 country: United States