In Vivo Preoperative Skin Preparation Persistence Evaluation

96-hour Antimicrobial Persistence Assessment Following Exposure to Saline and Blotting

Evaluate persistent antimicrobial effectiveness of chlorhexidine gluconate containing products on abdominal and inguinal sites following a saline and wipe challenge.

Study Overview

• Status: Completed
• Conditions: Bacterial Recovery of Skin Flora Post-product Application
• Intervention / Treatment: Drug: 3M CHG/IPA Prep; Drug: ChloraPrep

Detailed Description

Persistent antimicrobial effectiveness was evaluated by measuring the regrowth of normal skin flora at 48 hours, 72 hours and 96 hours, and the suppression of regrowth relative to post-prep (10-min) at 48 hours, 72 hours and 96 hours.

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Phase 2

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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3M CHG/IPA Prep; Apply topically for 30 seconds (abdominal site) or 2 minutes (inguinal site), and allow to dry for 3 minutes.	Drug: 3M CHG/IPA Prep; Apply topically to intact dry skin (abdominal site) for 30 seconds or moist skin (inguinal site) for 2 minutes.; Other Names: Chlorhexidine Gluconate and Isopropyl Alcohol; CHG/IPA
Active Comparator: ChloraPrep; Apply topically for 30 seconds (abdominal site) or 2 minutes (inguinal site), and allow to dry for 3 minutes.	Drug: ChloraPrep; Apply topically to intact dry skin (abdominal site) for 30 seconds or moist skin (inguinal site) for 2 minutes.; Other Names: Chlorhexidine Gluconate and Isopropyl Alcohol; ChloraPrep One-Step; CHG/IPA; Chlorhexidine 2% / Isopropyl alcohol 70%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of Skin Flora Recovery Post-prep Application	The primary measure of persistence is the suppression of regrowth recovery relative to baseline (log10 CFU/cm^2) of skin flora at 3 defined post-treatment sampling times.	Baseline, 48-hours post-treatment, 72-hours post-treatment and 96-hours post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Skin Flora Relative to 10 Minutes Post-prep Application	Log10 CFU/cm^2 regrowth of skin flora, relative to 10-minute post-treatment log10 CFU/cm^2, at 3 defined post-treatment sampling times.	10-minute post-treatment, 48-hours post-treatment, 72-hours post-treatment and 96-hours post-treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment	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.	Assessed at baseline (pre-treatment) and 10 minutes post-treatment, 48 hours post-treatment, 72 hours post-treatment, 96 hours post-treatment

Collaborators and Investigators

• Sponsor: 3M
• Investigators: Principal Investigator: Rozalia Olsavszky, MD, Evic / Eurofins

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2016
• Primary Completion (Actual): April 25, 2017
• Study Completion (Actual): April 25, 2017

Study Registration Dates

• First Submitted: May 11, 2017
• First Submitted That Met QC Criteria: May 15, 2017
• First Posted (Actual): May 16, 2017

Study Record Updates

• Last Update Posted (Actual): February 28, 2020
• Last Update Submitted That Met QC Criteria: February 20, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• 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-013953

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
• product manufactured in and exported from the U.S.: Yes