NCT01968356

In-vivo Efficacy Study of Patient Preoperative 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: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 171 (actual)
• Sponsor: Solventum US LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate 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

• Skin Flora Bacterial Reduction Post-product Application

Interventions

Type	Name	Description
DRUG	3M CHG/IPA Prep Colorless	Apply topically.
DRUG	3M CHG/IPA Prep Tint	Apply topically.
DRUG	ChloraPrep	Apply topically.
DRUG	Saline	Apply topically.

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2013-10-24
• Last updated: 2024-10-02
• Results posted: 2021-08-03

Locations

1 site across 1 country: United States