Efficacy Study of Patient Preoperative Preps In-vivo

Phase 3

Completed

• Conditions: Surgical Skin Preparation
• Interventions: Drug: Normal saline; Drug: CHG/IPA Surgical skin preparation

• Registration Number: NCT04756154
• Lead Sponsor: Solventum US LLC

Brief 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.

Study Timeline

• Study Start: 2020-07-06
• Study First Submitted: 2021-01-20
• Study First Submitted QC: 2021-02-11
• Study First Posted: 2021-02-16
• Primary Completion: 2021-04-28
• Study Completion: 2021-04-28
• Results First Submitted: 2023-05-22
• Results First Submitted QC: 2023-07-27
• Results First Posted: 2023-08-01
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-27
• Last Update Posted: 2024-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

Inclusion Criteria

• Subjects of any race
• Subjects in good health
• Minimum skin flora baseline requirements on inguinal region

Exclusion Criteria

• Any tattoos, scars, breaks in the skin, or any form of dermatitis, or other skin disorders (including acne) on the applicable test area
• Topical antimicrobial exposure within 14 days prior to screening and treatment days
• Use of systemic or topical antibiotics, steroid medications, or any other products known to affect the normal microbial flora of the skin within 14 days prior to screening and treatment days

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal saline	Normal saline	Apply topically to the inguinal region for 2 minutes
CHG/IPA Surgical skin preparation	CHG/IPA Surgical skin preparation	Apply topically to the inguinal region for 2 minutes
CHG/IPA Film-Forming Surgical skin preparation	CHG/IPA Surgical skin preparation	Apply topically to the inguinal region for 2 minutes

Primary Outcome Measures

Name	Time	Method
Log Change (Reduction) in Skin Flora on the Inguinal Region at 6 Hours	6 hours	Persistent efficacy endpoint which is a binary endpoint with success/failure, where "success" is defined as log10 CFU/cm2 of skin flora on the inguinal region at 6 hours following application of the study products being lower than the treatment day baseline skin flora
Log Change (Reduction) in Skin Flora on the Inguinal Region at 10 Minutes	10 minutes	Immediate efficacy endpoint which is defined as the average treatment effect (ATE) log10 CFU/cm2 of skin flora on the inguinal region at 10 minutes following application of the study products relative to the treatment day baseline skin flora

Trial Locations

Locations (1)

Microbac Laboratories, Inc; 🇺🇸 Sterling, Virginia, United States