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

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.

Study Overview

• Status: Completed
• Conditions: Surgical Skin Preparation
• Intervention / Treatment: Drug: CHG/IPA Surgical skin preparation; Drug: Normal saline

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 Type: Interventional
• Enrollment (Actual): 154
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Sterling, Virginia, United States, 20164
      • Microbac Laboratories, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CHG/IPA Surgical skin preparation; Apply topically to the inguinal region for 2 minutes	Drug: CHG/IPA Surgical skin preparation; Apply topically to the inguinal region for 2 minutes; Other Names: 2% CHG/70% IPA
Active Comparator: CHG/IPA Film-Forming Surgical skin preparation; Apply topically to the inguinal region for 2 minutes	Drug: CHG/IPA Surgical skin preparation; Apply topically to the inguinal region for 2 minutes; Other Names: 2% CHG/70% IPA
Placebo Comparator: Normal saline; Apply topically to the inguinal region for 2 minutes	Drug: Normal saline; Apply topically to the inguinal region for 2 minutes; Other Names: 0.9% sodium chloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Log Change (Reduction) in Skin Flora on the Inguinal Region at 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	10 minutes
Log Change (Reduction) in Skin Flora on the Inguinal Region at 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	6 hours

Collaborators and Investigators

• Sponsor: 3M
• Investigators: Principal Investigator: Muhammad H Bashir, MD, CCRP, Microbac

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2020
• Primary Completion (Actual): April 28, 2021
• Study Completion (Actual): April 28, 2021

Study Registration Dates

• First Submitted: January 20, 2021
• First Submitted That Met QC Criteria: February 11, 2021
• First Posted (Actual): February 16, 2021

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 27, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: EM-05-014624

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No