In Vivo Patient Preoperative Skin Prep Persistence

Assessment of Antimicrobial Persistence of 3M CHG/IPA Preoperative Skin Preparation Against Resident Flora on the Abdominal and Inguinal Regions

The objective of the study is to demonstrate persistence of the CHG/IPA Prep on skin flora of the abdominal and inguinal regions of human subjects.

Study Overview

• Status: Completed
• Conditions: Bacterial Recovery of Skin Flora Post-Product Application
• Intervention / Treatment: Drug: 3M CHG/IPA Surgical Skin Preparation - Abdominal Region; Other: Normal Saline - Abdominal Region; Drug: 3M CHG/IPA Surgical Skin Preparation - Inguinal Region; Other: Normal Saline - Inguinal Region

Detailed Description

The objective of the study is to demonstrate persistence of the CHG/IPA Prep versus a saline placebo on skin flora of the abdominal and inguinal regions of human subjects as measured by change in microbial flora relative to baseline.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Sterling, Virginia, United States, 20164
      • Microbiotest

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 general health
• Minimum skin flora baseline requirements on abdomen and groin

Exclusion Criteria:

• Any tattoos, scars, breaks in the skin, or any form of dermatitis, or other skin disorders (including acne) on the applicable test areas
• 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

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3M CHG/IPA - Abdominal Region; Apply Chlorhexidine (CHG) 2% / Isopropyl alcohol (IPA) 70% for 30 seconds and allow to dry for 3 minutes.	Drug: 3M CHG/IPA Surgical Skin Preparation - Abdominal Region; Chlorhexidine gluconate 2% / Isopropyl alcohol 70%; Other Names: SoluPrep
Placebo Comparator: Normal Saline - Abdominal Region; Apply 0.9% sodium chloride with applicator for 30 seconds and allow to dry for 3 minutes.	Other: Normal Saline - Abdominal Region; 0.9% sodium chloride applied with foam applicator
Experimental: 3M CHG/IPA - Inguinal Region; Apply Chlorhexidine (CHG) 2% / Isopropyl alcohol (IPA) 70% for 30 seconds and allow to dry for 3 minutes.	Drug: 3M CHG/IPA Surgical Skin Preparation - Inguinal Region; Chlorhexidine gluconate 2% / Isopropyl alcohol 70%; Other Names: SoluPrep
Placebo Comparator: Normal Saline - Inguinal Region; Apply 0.9% sodium chloride with applicator for 30 seconds and allow to dry for 3 minutes.	Other: Normal Saline - Inguinal Region; 0.9% sodium chloride applied with foam applicator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of Skin Flora Recovery Post-prep Application Relative to Baseline	The primary measure of persistence is the suppression of regrowth recovery relative to baseline (log10 CFU/cm^2) of skin flora at two defined post-prep sampling times relative to baseline.	Baseline, 48 hours and 72 hours post-prep application

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety as Assessed by Skin Irritation Scores Coded by Study Staff	For the conditions of erythema, edema, rash, and dryness, a rating of 0 (no reaction), 1 (mild and/or transient, limited to sensitive area), 2 (moderate, persisting over much of the product-exposed area), or 3 (severe, extending over most or all of the product-exposed area) was recorded on the Skin Irritation Rating form of the eCRF.	48 hours and 72 hours post-product application
Safety as Assessed by Adverse Events	Number of subjects with adverse events as self-reported or identified by study staff	To 72 hours post treatment

Collaborators and Investigators

• Sponsor: Solventum US LLC
• Collaborators: 3M
• Investigators: Principal Investigator: Muhammad H Bashir, MD, CCRP, MicroBioTest Inc.

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: May 8, 2015
• First Submitted That Met QC Criteria: May 14, 2015
• First Posted (Estimated): May 19, 2015

Study Record Updates

• Last Update Posted (Actual): October 2, 2024
• Last Update Submitted That Met QC Criteria: September 30, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: EM-05-013509

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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