NCT04756154

Efficacy Study of Patient Preoperative Preps In-vivo

Assessment of the Antimicrobial Efficacy of 3M™ SoluPrep™ Preoperative Skin Preparation Against Resident Human Skin Flora on the Inguinal Region

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 154 (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 an investigational CHG/IPA prep on skin flora of the inguinal regions of human subjects.

Detailed description

Non-inferiority of the investigational product to the FDA-approved active control for log10/cm2 recovery of skin flora relative to Treatment Day baseline log10/cm2 on the inguinal region at 10 minutes following application. Non-inferiority is based on a non-inferiority margin of 0.5 log10/cm2. Superiority of the active products to the negative control for log10/cm2 recovery of skin flora relative to Treatment Day baseline log10/cm2 on the inguinal region at 10 minutes following application. A superiority margin of 1.2 log10/cm2 is used. Number of observations for which the log10/cm2 recovery of skin flora on the inguinal region at 6 hours following application of the study products is higher than treatment day log10/cm2 baseline skin flora.

Conditions

• Surgical Skin Preparation

Interventions

Type	Name	Description
DRUG	CHG/IPA Surgical skin preparation	Apply topically to the inguinal region for 2 minutes
DRUG	Normal saline	Apply topically to the inguinal region for 2 minutes

Timeline

• Start date: 2020-07-06
• Primary completion: 2021-04-28
• Completion: 2021-04-28
• First posted: 2021-02-16
• Last updated: 2024-10-01
• Results posted: 2023-08-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study