In Vivo Efficacy Study of Patient Preoperative Preps

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Bacterial Reduction Post-product Application

Intervention / Treatment
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* Drug: 3M CHG/IPA Prep C
* Drug: 3M CHG/IPA Prep CH
* Drug: ChloraPrep
* 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 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 C<br>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<br>* Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.<br>* Other names: CHG 2%/IPA 70%;|
| Experimental: 3M CHG/IPA Prep CH<br>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<br>* Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.<br>* Other names: CHG 2%/IPA 70%;|
| Active Comparator: ChloraPrep<br>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<br>* Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.<br>* Other names: Chlorhexidine Gluconate and Isopropyl Alcohol;|
| Placebo Comparator: Normal Saline<br>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<br>* Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.<br>* Other names: Saline;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IPA, surgical skin prep, CHG