Efficacy Study of Patient Preoperative Preps In-vivo

• Sponsor: 3M (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04756154
• Collaborator: (none)
• Enrollment: 135
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 10.8
• Patients Per Site Per Month: 12.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Surgical Skin Preparation	Drug: CHG/IPA Surgical skin preparation; Drug: Normal saline	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 135 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Assessment of the Antimicrobial Efficacy of 3M™ SoluPrep™ Preoperative Skin Preparation Against Resident Human Skin Flora on the Inguinal Region
• Actual Study Start Date: Jul 6, 2020
• Anticipated Primary Completion Date: May 15, 2021
• Anticipated Study Completion Date: May 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SP	Drug: CHG/IPA Surgical skin preparation; Apply topically
Active Comparator: SPFF	Drug: CHG/IPA Surgical skin preparation; Apply topically
Placebo Comparator: S	Drug: Normal saline; Apply topically

Outcome Measures

Primary Outcome Measures

1. Log change 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

2. Log change 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Microbac Laboratories, Inc	Sterling	Virginia	United States	20164

Sponsors and Collaborators

• 3M

Investigators

• Principal Investigator: Muhammad H Bashir, MD, CCRP, Microbac

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: 3M
• ClinicalTrials.gov Identifier: NCT04756154
• Other Study ID Numbers: EM-05-014624
• First Posted: Feb 16, 2021
• Last Update Posted: Mar 1, 2021
• Last Verified: Feb 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Mar 1, 2021