In-vivo Efficacy Study of Patient Preoperative Preps

Study Overview
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Brief Summary
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The purpose of this study is to evaluate 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 sites, a responder is defined as a subject with a 2-log10 per cm2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at 6 hours. On the inguinal sites, a responder is defined as a subject with a 3-log10 per 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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Skin Flora Bacterial Reduction Post-product Application

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects of any race Subjects in good general 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 areas 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 Colorless<br>Applied 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 Colorless<br>* Apply topically.<br>* Other names: Chlorhexidine gluconate 2% / Isopropyl alcohol 70%;|
| Experimental: 3M CHG/IPA Prep Tint<br>Applied 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 Tint<br>* Apply topically.<br>* Other names: Chlorhexidine gluconate 2% / Isopropyl alcohol 70%;|
| Active Comparator: ChloraPrep Hi-Lite Orange<br>Applied 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.<br>* Other names: Chlorhexidine gluconate 2% / Isopropyl alcohol 70%;|
| Placebo Comparator: Normal Saline<br>Applied topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes. | Drug: Saline<br>* Apply topically.<br>* Other names: Normal 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 was a subject with a 2-log10/cm2 bacterial reduction at 10 minutes and for whom the skin flora did not return to baseline at 6 hours. On the inguinal region a responder was a subject with a 3-log10/cm2 bacterial reduction at 10 minutes and for whom the skin flora did not return to baseline at 6 hours. | baseline, 10 minute post-product application and 6 hour post-product application | 
| Skin Flora Baseline for Abdominal and Inguinal Regions | Log10/cm2 baseline skin flora for abdominal and inguinal regions | Baseline | 
| Skin Flora Recovery Post-treatment | Log10/cm2 recovery of skin flora at 10 minutes and 6 hours following application of study treatments for abdominal and inguinal regions | 10 minutes and 6 hours post-treatment | 
| Reduction of Skin Flora Post-treatment | Log10/cm2 reduction of skin flora, relative to Treatment Day baseline log10/cm2, at 10 minutes and 6 hours | Baseline, 10 minutes and 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety as Assessed by Skin Irritation Scores | Skin irritation rating (0-3) scores for dryness, edema, erythema and rash. 0 = no reaction, 1 = mild, 2 = moderate, 3 = severe. A skin irritation rating of 3 in any category represents significant irritation and qualifies as an adverse event. | Baseline | 
| Safety as Assessed by Skin Irritation Scores | Skin irritation rating (0-3) scores for dryness, edema, erythema and rash. 0 = no reaction, 1 = mild, 2 = moderate, 3 = severe. A skin irritation rating of 3 in any category represents significant irritation and qualifies as an adverse event. | 10 minutes post-treatment | 
| Safety as Assessed by Skin Irritation Scores | Skin irritation rating (0-3) scores for dryness, edema, erythema and rash. 0 = no reaction, 1 = mild, 2 = moderate, 3 = severe. A skin irritation rating of 3 in any category represents significant irritation and qualifies as an adverse event. | 6 hours post-treatment | 

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