Efficacy Study of Patient Preoperative Preps In-vivo

Study Overview
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Brief Summary
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The purpose of this study is to determine the antimicrobial efficacy of an investigational CHG/IPA prep on skin flora of the inguinal regions of human subjects.

Detailed Description
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Non-inferiority of the investigational product to the FDA-approved active control for log10/cm2 recovery of skin flora relative to Treatment Day baseline log10/cm2 on the inguinal region at 10 minutes following application. Non-inferiority is based on a non-inferiority margin of 0.5 log10/cm2. Superiority of the active products to the negative control for log10/cm2 recovery of skin flora relative to Treatment Day baseline log10/cm2 on the inguinal region at 10 minutes following application. A superiority margin of 1.2 log10/cm2 is used. Number of observations for which the log10/cm2 recovery of skin flora on the inguinal region at 6 hours following application of the study products is higher than treatment day log10/cm2 baseline skin flora.

Official Title
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Assessment of the Antimicrobial Efficacy of 3M™ SoluPrep™ Preoperative Skin Preparation Against Resident Human Skin Flora on the Inguinal Region

Conditions
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Surgical Skin Preparation

Intervention / Treatment
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* Drug: CHG/IPA Surgical skin preparation
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects of any race Subjects in good health Minimum skin flora baseline requirements on inguinal region 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CHG/IPA Surgical skin preparation<br>Apply topically to the inguinal region for 2 minutes | Drug: CHG/IPA Surgical skin preparation<br>* Apply topically to the inguinal region for 2 minutes<br>* Other names: 2% CHG/70% IPA;|
| Active Comparator: CHG/IPA Film-Forming Surgical skin preparation<br>Apply topically to the inguinal region for 2 minutes | Drug: CHG/IPA Surgical skin preparation<br>* Apply topically to the inguinal region for 2 minutes<br>* Other names: 2% CHG/70% IPA;|
| Placebo Comparator: Normal saline<br>Apply topically to the inguinal region for 2 minutes | Drug: Normal saline<br>* Apply topically to the inguinal region for 2 minutes<br>* Other names: 0.9% sodium chloride;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Log Change (Reduction) in Skin Flora on the Inguinal Region at 10 Minutes | Immediate efficacy endpoint which is defined as the average treatment effect (ATE) log10 CFU/cm2 of skin flora on the inguinal region at 10 minutes following application of the study products relative to the treatment day baseline skin flora | 10 minutes | 
| Log Change (Reduction) in Skin Flora on the Inguinal Region at 6 Hours | Persistent efficacy endpoint which is a binary endpoint with success/failure, where success is defined as log10 CFU/cm2 of skin flora on the inguinal region at 6 hours following application of the study products being lower than the treatment day baseline skin flora | 6 hours |