In-vivo Efficacy Study of Patient Pre-operative Preps

May 26, 2021 updated by: 3M

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 determine the antimicrobial efficacy of the 3M CHG/IPA Prep on skin flora of the abdominal and inguinal regions of human subjects.

Study Overview

Status

Completed

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)

426

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

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

Genders Eligible for Study

All

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
Placebo Comparator: Normal Saline
Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.
Drug: Normal saline
Apply topically.
Other Names:
  • Saline
  • 0.9% NaCl
  • 0.9% Sodium Chloride
  • Sterile Saline
Active Comparator: ChloraPrep Hi-Lite Orange
Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.
Drug: ChloraPrep Hi-Lite Orange
Apply topically.
Other Names:
  • Chlorhexidine gluconate 2% / Isopropyl alcohol 70%
  • ChloraPrep One-Step
  • ChloraPrep
  • Chlorhexidine gluconate 2% w/v / Isopropyl alcohol 70% v/v
  • 2% CHG / 70% IPA
  • Chlorhexidine Gluconate and Isopropyl alcohol
Experimental: 3M CHG/IPA Prep Tint 10.5 mL
Apply 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 10.5-mL
Apply topically.
Other Names:
  • Chlorhexidine Gluconate and Isopropyl Alcohol
  • Chlorhexidine gluconate 2% / Isopropyl alcohol 70%
  • Chlorhexidine gluconate 2% w/v / Isopropyl alcohol 70% v/v
  • 2% CHG / 70% IPA
Experimental: 3M CHG/IPA Prep Tint 26-mL
Apply 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 26-mL
Apply topically
Other Names:
  • Chlorhexidine Gluconate and Isopropyl Alcohol
  • Chlorhexidine gluconate 2% / Isopropyl alcohol 70%
  • Chlorhexidine gluconate 2% w/v / Isopropyl alcohol 70% v/v
  • 2% CHG / 70% IPA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Responder Rate
Time Frame: baseline, 10 minutes 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.

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.
baseline, 10 minutes post-product application and 6 hour post-product application

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of Skin Flora 6 Hours Post-treatment
Time Frame: 6 hours
log10/cm2 reduction of skin flora, relative to treatment day baseline (log10/cm2), at 6 hours post-treatment
6 hours
Reduction of Skin Flora 10 Minutes Post-treatment
Time Frame: 10 minutes
log10/cm2 reduction of skin flora, relative to treatment day baseline (log10/cm2), at 10 minutes post-treatment
10 minutes
Skin Flora Recovery 6-hours Post-treatment
Time Frame: 6 hours post-treatment
Log10/cm2 recovery of skin flora at 6 hours following application of study treatment
6 hours post-treatment
Skin Flora Recovery 10 Minutes Post-treatment
Time Frame: 10 minutes post-treatment
Log10/cm2 recovery of skin flora at 10 minutes following application of study treatments
10 minutes post-treatment
Skin Flora Baseline for the Abdominal and Inguinal Region.
Time Frame: Baseline
Log10/cm2 baseline skin flora for abdominal and inguinal regions
Baseline
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
Time Frame: Assessed at baseline (pre-treatment) and 10 minute post-treatment and 6 hour post-treatment.
Skin irritation (dryness, edema, erythema, rash) assessed on the test sites using a 0-3 rating scale: 0=no reaction, 1=mild, 2=moderated, 3=severe
Assessed at baseline (pre-treatment) and 10 minute post-treatment and 6 hour post-treatment.

Collaborators and Investigators

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

Sponsor

3M

Investigators

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

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)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

October 21, 2013

First Submitted That Met QC Criteria

October 23, 2013

First Posted (Estimate)

October 24, 2013

Study Record Updates

Last Update Posted (Actual)

June 9, 2021

Last Update Submitted That Met QC Criteria

May 26, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EM-012760

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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