In-vivo Efficacy Study of Patient Pre-operative Preps

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the antimicrobial efficacy of the 3M CHG/IPA Prep on skin flora of the abdominal and inguinal regions of human subjects.

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

Conditions
-----------------
Bacterial Reduction on Skin Flora Post-product Application

Intervention / Treatment
-----------------
* Drug: ChloraPrep Hi-Lite Orange
* Drug: Normal saline
* Drug: 3M CHG/IPA Prep Tint 10.5-mL
* Drug: 3M CHG/IPA Prep Tint 26-mL


Participation Criteria
=================
Eligibility Criteria
-----------------
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
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ChloraPrep Hi-Lite Orange<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 Hi-Lite Orange<br>* Apply topically.<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.<br>* Other names: Saline;|
| Experimental: 3M CHG/IPA Prep Tint 10.5 mL<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 Tint 10.5-mL<br>* Apply topically.<br>* Other names: 2% CHG / 70% IPA;|
| Experimental: 3M CHG/IPA Prep Tint 26-mL<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 Tint 26-mL<br>* Apply topically<br>* Other names: 2% CHG / 70% IPA;|

What is the study measuring?
-----------------
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. 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. | baseline, 10 minutes post-product application and 6 hour post-product application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of Skin Flora 6 Hours Post-treatment | log10/cm2 reduction of skin flora, relative to treatment day baseline (log10/cm2), at 6 hours post-treatment | 6 hours | 
| Reduction of Skin Flora 10 Minutes Post-treatment | log10/cm2 reduction of skin flora, relative to treatment day baseline (log10/cm2), at 10 minutes post-treatment | 10 minutes | 
| Skin Flora Recovery 6-hours Post-treatment | Log10/cm2 recovery of skin flora at 6 hours following application of study treatment | 6 hours post-treatment | 
| Skin Flora Recovery 10 Minutes Post-treatment | Log10/cm2 recovery of skin flora at 10 minutes following application of study treatments | 10 minutes post-treatment | 
| Skin Flora Baseline for the Abdominal and Inguinal Region. | Log10/cm2 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=moderated, 3=severe | Assessed at baseline (pre-treatment) and 10 minute post-treatment and 6 hour post-treatment. | 

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