Pilot Evaluation of the Application Procedure on the Antimicrobial Effects of 2 Antiseptics

Study Overview
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Brief Summary
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Evaluate effect of application procedure on efficacy of 2 antiseptics for cleaning skin prior to surgery.

Detailed Description
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Evaluate the effect of application procedure on the antimicrobial properties of a new product and a currently marketed product. Study will be conducted using methods dictated by the FDA. Study uses topical sampling from the abdomen and groin on intact skin and evaluates the germs. Effects of blotting versus not blotting will be assessed.

Official Title
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Pilot Evaluation of the Effect of Application Procedure on the Antimicrobial Effects of an Aqueous CHG and a Traditional Iodophor Scrub Paint

Conditions
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Healthy

Intervention / Treatment
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* Drug: Chlorhexidine gluconate
* Drug: Povidone iodine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Free of dermatoses, cuts, lesions, or other skin disorders around test sites must not have received topical or systemic antimicrobials, antibiotics, or steroids for 7 days prior to testing and 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 7 day pre-test period or during the test period exposure of the test sites to strong detergents, solvents, or other irritants during the 7 day pre-test period or during the test period use of systemic or topical antibiotic medications, steroid medications, or any other product known to affect the normal microbial flora of the skin during the 7 day pre-test period or during the test period known allergy to latex (rubber), alcohols, inks, or tape adhesives, or to common antibacterial agents found in soaps, lotions, or ointments, particularly chlorhexidine gluconate and povidone iodine active skin rashes or breaks in the skin of the test sites currently active skin disease or inflammatory skin condition, including contact dermatitis showering or bathing within the 72 hour period prior to sampling participation in a clinical study in the past 7 days or current participation in another clinical study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Chlorhexidine gluconate 2% | Drug: Chlorhexidine gluconate<br>* Chlorhexidine gluconate (2% w/v) in an aqueous base. Administered topically.<br>* Other names: ChloraPrep AQ;|
| Active Comparator: 2<br>Povidone iodine scrub and paint | Drug: Povidone iodine<br>* Povidone iodine scrub and paint. Administer topically.<br>* Other names: Betadine;|

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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of blotting versus not blotting |  | Blotting and not blotting after 2 minute application with CHG and 5 minute application of iodophor | 

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