In Vivo Preoperative Skin Preparation Persistence Evaluation

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

Detailed Description
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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.

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

Conditions
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Bacterial Recovery of Skin Flora Post-product Application

Intervention / Treatment
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* Drug: 3M CHG/IPA Prep
* Drug: ChloraPrep


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 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

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: 3M CHG/IPA Prep<br>Apply topically for 30 seconds (abdominal site) or 2 minutes (inguinal site), and allow to dry for 3 minutes. | Drug: 3M CHG/IPA Prep<br>* Apply topically to intact dry skin (abdominal site) for 30 seconds or moist skin (inguinal site) for 2 minutes.<br>* Other names: CHG/IPA;|
| Active Comparator: ChloraPrep<br>Apply topically for 30 seconds (abdominal site) or 2 minutes (inguinal site), and allow to dry for 3 minutes. | Drug: ChloraPrep<br>* Apply topically to intact dry skin (abdominal site) for 30 seconds or moist skin (inguinal site) for 2 minutes.<br>* Other names: ChloraPrep One-Step;|

What is the study measuring?
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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 |