Preoperative Skin Preparation Evaluation

Study Overview
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Brief Summary
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Determine the antimicrobial properties of a proposed new product and an already approved product and a placebo (no drug). Study will be conducted using methods dictated by the FDA.

Detailed Description
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Determine the antimicrobial properties of a proposed new product and an already approved product and a placebo (no drug). Study will be conducted using methods dictated by the FDA. This study uses topical sampling from the abdomen and the groin on intact skin and evaluates the germs left on the skin after treatment with the proposed new product, the currently approved product and the placebo.

Official Title
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Preoperative Skin Preparation Evaluation of One Test Product With a Positive and a Negative Control

Conditions
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Topical Antisepsis

Intervention / Treatment
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* Drug: Chlorhexidine gluconate
* Drug: ChloraPrep One Step
* Drug: Sterile saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Free of dermatoses, cuts, lesions, or other skin disorders on or around the test sites; no exposure to topical or systemic antimicrobials, antibiotics, or steroids (other than contraceptives, for the fourteen (14) day pre-test conditioning period and must agree to abstain from these materials until completion of the study Exclusion Criteria: Exposure of test sites to antimicrobial agents, medicated soaps, medicated shampoos, or medicated lotions, Use of biocide-treated pools or hot tubs, use of tanning beds, or sunbathing during the fourteen(14) day pre-test conditioning period or during the test period; Exposure of the test sites to strong detergent, solvents, or other irritants during the fourteen (14) day pre-test conditioning period or during the test period; Use of systemic or topical antibiotic medications, steroid medications other than contraceptives, or any other product known to affect the normal microbial flora of the skin during the fourteen ()14) day pre-test conditioning period or during the test period; Know of allergies to vinyl, latex (rubber), alcohols, metals, inks, or tape adhesives, or to common antibacterial agents found in soaps, lotions, or ointments, particularly chlorhexidine gluconate, and/or isopropyl alcohol; A medical diagnosis of a physical condition, such as a current or recent severe illness, asthma, diabetes, hepatitis, an organ transplant, any immunocompromised conditions such as AIDS (or HIV positive), mitral valve prolapse, or a requirement to take antibiotics prior to dental procedures; Pregnancy, plans to become pregnant within the pre-test and test periods of the study, or nursing a child; Any active skin rashes or breaks in the skin of the test sites; A currently active skin disease or inflammatory skin condition, including contact dermatitis; showering or bathing within the seventy-two (72) hour period prior to sampling; participation in another clinical study in the past thirty (30) days or current participation in another clinical study; Any medical condition or use of any medications, that, in the opinion of the Study Director, should preclude participation; Unwillingness to fulfill the performance requirements of the study.

Ages Eligible for Study
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Minimum Age: 16 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CHG 2%-26 ml<br>Chlorhexidine gluconate in an aqueous base, 26 ml applicator | Drug: Chlorhexidine gluconate<br>* Chlorhexidine gluconate (2% w/v) in an aqueous base, 26 ml applicator. Active drug contains alcohol and the placebo contains no drug. Administered topically.<br>* Other names: ChloraPrep AQ;|
| Active Comparator: ChloraPrep 26 ml<br>ChloraPrep One-Step 26 ml Active drug contains chlorhexidine gluconate and alcohol | Drug: ChloraPrep One Step<br>* Administer topically<br>* Other names: Chlorhexidine gluconate 2% w/v and 70% v/v isopropyl alcohol;|
| Placebo Comparator: Sterile Saline<br>Sterile salt water administered topically. | Drug: Sterile saline<br>* 0.9% NaCl solution<br>* Other names: Physiologic saline (0.9% NaCl);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3.0 log10 reduction in CFU/cm2 on inguinal sites, and 2.0 log10 reduction in CFU/cm2 on abdominal sites |  | 10 minutes and 6 hours after application of test solutions | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antimicrobial, Antisepsis