In Vivo Efficacy Study of Patient Preoperative Preps

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

The objective of this study is to demonstrate 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: Bacterial Reduction Post-product Application
• Intervention / Treatment: Drug: 3M CHG/IPA Prep C; Drug: 3M CHG/IPA Prep CH; Drug: ChloraPrep; Drug: Normal Saline

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 site, a responder is defined as a subject with a 2-log10/cm2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at 6 hours.

On the inguinal site, a responder is defined as a subject with a 3-log10/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): 738
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects of any race
• Subjects in good 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 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

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 Prep C; 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 C; Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.; Other Names: Chlorhexidine Gluconate and Isopropyl Alcohol; Chlorhexidine gluconate 2% / Isopropyl alcohol 70%; CHG 2%/IPA 70%
Experimental: 3M CHG/IPA Prep CH; 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 CH; Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.; Other Names: Chlorhexidine Gluconate and Isopropyl Alcohol; Chlorhexidine gluconate 2% / Isopropyl alcohol 70%; CHG 2%/IPA 70%
Active Comparator: ChloraPrep; 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; Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.; Other Names: Chlorhexidine Gluconate and Isopropyl Alcohol; Chlorhexidine gluconate 2% / Isopropyl alcohol 70%; ChloraPrep Patient Preoperative Skin Preparation; ChloraPrep One-Step; CHG2%/IPA 70%
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 for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.; Other Names: Saline; Sodium Chloride 0.9%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Responder Rate	On the abdominal region a responder is a subject with a 2 log10/cm^2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at the 6-hour sample collection time. On the inguinal region a responder is a subject with a 3 log10/cm^2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at the 6-hour sample collection time.	baseline, 10 minutes post-product application and 6 hours post-product application
Alternative Primary	10 minute log reduction	Baseline and 10 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: 3M
• Investigators: Principal Investigator: Jamie Miller, ADN, Independent consultant

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: July 28, 2014
• First Submitted That Met QC Criteria: July 28, 2014
• First Posted (Estimate): July 30, 2014

Study Record Updates

• Last Update Posted (Actual): November 23, 2020
• Last Update Submitted That Met QC Criteria: October 30, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: surgical skin prep; CHG; IPA
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Central Nervous System Depressants; Dermatologic Agents; Disinfectants; Ethanol; Chlorhexidine; Chlorhexidine gluconate
• Other Study ID Numbers: EM-013260

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No