Efficacy Study of Patient Preoperative Preps In-vivo

NCT04756154 | Completed Phase 3 Results FDA Drug

• 1 other identifier: EM-05-014624
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Skin Preparation

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

CHG/IPA Surgical skin preparation

EXPERIMENTAL

Apply topically to the inguinal region for 2 minutes

Drug: CHG/IPA Surgical skin preparation

CHG/IPA Film-Forming Surgical skin preparation

ACTIVE COMPARATOR

Apply topically to the inguinal region for 2 minutes

Drug: CHG/IPA Surgical skin preparation

Normal saline

PLACEBO COMPARATOR

Apply topically to the inguinal region for 2 minutes

Drug: Normal saline

Interventions

CHG/IPA Surgical skin preparation DRUG

Apply topically to the inguinal region for 2 minutes

Also known as: 2% CHG/70% IPA

CHG/IPA Film-Forming Surgical skin preparation; CHG/IPA Surgical skin preparation

Normal saline DRUG

Apply topically to the inguinal region for 2 minutes

Also known as: 0.9% sodium chloride

Normal saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Solventum US LLC: lead
• 3M: collaborator

Study Sites (1)

Microbac Laboratories, Inc

Sterling, Virginia, 20164, United States

Location

MeSH Terms

Interventions

Saline Solution; Sodium Chloride

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Linda Olson
• Organization: 3M

lkolson2@mmm.com

651-736-3586

Study Officials

• Muhammad H Bashir, MD, CCRP

  Microbac

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2021
• First Posted: February 16, 2021
• Study Start: July 6, 2020
• Primary Completion: April 28, 2021
• Study Completion: April 28, 2021
• Last Updated: October 1, 2024
• Results First Posted: August 1, 2023

Record last verified: 2024-09

Locations

US (1)