In-vivo Efficacy Study of Patient Preoperative Preps

September 30, 2024 updated by: Solventum US LLC

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

The purpose of this study is to evaluate the antimicrobial efficacy of the 3M CHG/IPA Prep on skin flora of the abdominal and inguinal regions of human subjects.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The primary efficacy is evaluated by demonstration that the product provides a lower bound of the 95% confidence interval of percent responders that is greater than or equal to 70%. On the abdominal sites, a responder is defined as a subject with a 2-log10 per cm2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at 6 hours. On the inguinal sites, a responder is defined as a subject with a 3-log10 per cm2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at 6 hours.

Study Type

Interventional

Enrollment (Actual)

171

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Montana
      • Bozeman, Montana, United States, 59718
        • BioScience Laboratories, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 3M CHG/IPA Prep Colorless
Applied topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.
Drug: 3M CHG/IPA Prep Colorless
Apply topically.
Other Names:
  • CHG 2% / IPA 70%
  • Chlorhexidine gluconate 2% / Isopropyl alcohol 70%
  • Chlorhexidine glucontate and Isopropyl alcohol
Experimental: 3M CHG/IPA Prep Tint
Applied topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.
Drug: 3M CHG/IPA Prep Tint
Apply topically.
Other Names:
  • Chlorhexidine gluconate 2% / Isopropyl alcohol 70%
  • CHG 2%/IPA 70%
  • Chlorhexidine glucontate and Isopropyl alcohol
Active Comparator: ChloraPrep Hi-Lite Orange
Applied topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.
Drug: ChloraPrep
Apply topically.
Other Names:
  • Chlorhexidine gluconate 2% / Isopropyl alcohol 70%
  • ChloraPrep Patient Preoperative Skin Preparation
  • ChloraPrep One-Step
  • Chlorhexidine glucontate and Isopropyl alcohol
  • 2% CHG/70% IPA
Placebo Comparator: Normal Saline
Applied topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.
Drug: Saline
Apply topically.
Other Names:
  • 0.9% NaCl
  • Normal Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Responder Rate
Time Frame: baseline, 10 minute post-product application and 6 hour post-product application

On the abdominal region a responder was a subject with a 2-log10/cm2 bacterial reduction at 10 minutes and for whom the skin flora did not return to baseline at 6 hours.

On the inguinal region a responder was a subject with a 3-log10/cm2 bacterial reduction at 10 minutes and for whom the skin flora did not return to baseline at 6 hours.
baseline, 10 minute post-product application and 6 hour post-product application
Skin Flora Baseline for Abdominal and Inguinal Regions
Time Frame: Baseline
Log10/cm2 baseline skin flora for abdominal and inguinal regions
Baseline
Skin Flora Recovery Post-treatment
Time Frame: 10 minutes and 6 hours post-treatment
Log10/cm2 recovery of skin flora at 10 minutes and 6 hours following application of study treatments for abdominal and inguinal regions
10 minutes and 6 hours post-treatment
Reduction of Skin Flora Post-treatment
Time Frame: Baseline, 10 minutes and 6 hours
Log10/cm2 reduction of skin flora, relative to Treatment Day baseline log10/cm2, at 10 minutes and 6 hours
Baseline, 10 minutes and 6 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety as Assessed by Skin Irritation Scores
Time Frame: Baseline
Skin irritation rating (0-3) scores for dryness, edema, erythema and rash. 0 = no reaction, 1 = mild, 2 = moderate, 3 = severe. A skin irritation rating of 3 in any category represents significant irritation and qualifies as an adverse event.
Baseline
Safety as Assessed by Skin Irritation Scores
Time Frame: 10 minutes post-treatment
Skin irritation rating (0-3) scores for dryness, edema, erythema and rash. 0 = no reaction, 1 = mild, 2 = moderate, 3 = severe. A skin irritation rating of 3 in any category represents significant irritation and qualifies as an adverse event.
10 minutes post-treatment
Safety as Assessed by Skin Irritation Scores
Time Frame: 6 hours post-treatment
Skin irritation rating (0-3) scores for dryness, edema, erythema and rash. 0 = no reaction, 1 = mild, 2 = moderate, 3 = severe. A skin irritation rating of 3 in any category represents significant irritation and qualifies as an adverse event.
6 hours post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Solventum US LLC

Collaborators

3M

Investigators

  • Principal Investigator: Robert R McCormack, BS, BioScience Laboratories, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

October 21, 2013

First Submitted That Met QC Criteria

October 21, 2013

First Posted (Estimated)

October 24, 2013

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

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EM-012759

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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