Efficacy Study of Patient Preoperative Preps In-vivo

Surgical Skin Preparation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04756154
• Other study ID #: EM-05-014624
• Status: Completed
• Phase: Phase 3
• Start date: July 6, 2020
• Est. completion date: April 28, 2021

Study information

• Verified date: July 2023
• Source: 3M
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: April 28, 2021
• Est. primary completion date: April 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Surgical Skin Preparation

Intervention

Drug:
• CHG/IPA Surgical skin preparation
Apply topically to the inguinal region for 2 minutes
• Normal saline
Apply topically to the inguinal region for 2 minutes

Locations

Country	Name	City	State
United States	Microbac Laboratories, Inc	Sterling	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
3M

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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