In Vivo Patient Preoperative Skin Prep Persistence

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to demonstrate persistence of the CHG/IPA Prep on skin flora of the abdominal and inguinal regions of human subjects.

Detailed Description
-----------------
The objective of the study is to demonstrate persistence of the CHG/IPA Prep versus a saline placebo on skin flora of the abdominal and inguinal regions of human subjects as measured by change in microbial flora relative to baseline.

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

Conditions
-----------------
Bacterial Recovery of Skin Flora Post-Product Application

Intervention / Treatment
-----------------
* Drug: 3M CHG/IPA Surgical Skin Preparation - Abdominal Region
* Other: Normal Saline - Abdominal Region
* Drug: 3M CHG/IPA Surgical Skin Preparation - Inguinal Region
* Other: Normal Saline - Inguinal Region


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 |
| --- | --- |
| Experimental: 3M CHG/IPA - Abdominal Region<br>Apply Chlorhexidine (CHG) 2% / Isopropyl alcohol (IPA) 70% for 30 seconds and allow to dry for 3 minutes. | Drug: 3M CHG/IPA Surgical Skin Preparation - Abdominal Region<br>* Chlorhexidine gluconate 2% / Isopropyl alcohol 70%<br>* Other names: SoluPrep;|
| Placebo Comparator: Normal Saline - Abdominal Region<br>Apply 0.9% sodium chloride with applicator for 30 seconds and allow to dry for 3 minutes. | Other: Normal Saline - Abdominal Region<br>* 0.9% sodium chloride applied with foam applicator<br>|
| Experimental: 3M CHG/IPA - Inguinal Region<br>Apply Chlorhexidine (CHG) 2% / Isopropyl alcohol (IPA) 70% for 30 seconds and allow to dry for 3 minutes. | Drug: 3M CHG/IPA Surgical Skin Preparation - Inguinal Region<br>* Chlorhexidine gluconate 2% / Isopropyl alcohol 70%<br>* Other names: SoluPrep;|
| Placebo Comparator: Normal Saline - Inguinal Region<br>Apply 0.9% sodium chloride with applicator for 30 seconds and allow to dry for 3 minutes. | Other: Normal Saline - Inguinal Region<br>* 0.9% sodium chloride applied with foam applicator<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of Skin Flora Recovery Post-prep Application Relative to Baseline | The primary measure of persistence is the suppression of regrowth recovery relative to baseline (log10 CFU/cm^2) of skin flora at two defined post-prep sampling times relative to baseline. | Baseline, 48 hours and 72 hours post-prep application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety as Assessed by Skin Irritation Scores Coded by Study Staff | For the conditions of erythema, edema, rash, and dryness, a rating of 0 (no reaction), 1 (mild and/or transient, limited to sensitive area), 2 (moderate, persisting over much of the product-exposed area), or 3 (severe, extending over most or all of the product-exposed area) was recorded on the Skin Irritation Rating form of the eCRF. | 48 hours and 72 hours post-product application | 
| Safety as Assessed by Adverse Events | Number of subjects with adverse events as self-reported or identified by study staff | To 72 hours post treatment |