Test for Pre Operative Skin Preparations

Study Overview
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Brief Summary
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Compare 2 application techniques of ChloraPrep Swabstick--3 swabsticks at once versus 3 swabsticks used sequentially. Hibiclens applied according to the manufacturer's directions. Sterile swabsticks (wetted with sterile deionizd water) applied using the same method as the ChloraPrep Swabstick.

Detailed Description
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Determine differences (if any) in 2 different application techniques of ChloraPrep Swabstick--3 swabsticks at once versus 3 swabsticks used sequentially. Hibiclens, a liquid antibacterial soap, applied according to the manufacturer's directions as a active/positive comparison. Sterile swabsticks (wetted with sterile deionized water) applied as a negative comparison using the same method as the ChloraPrep swabstick. Study uses topical sampling from the abdomen and the groin on intact skin and evaluates the germs left on the skin after treatment with ChloraPrep Swabsticks.

Official Title
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Test for Pre Operative Skin Preparations: ChloraPrep Triple Swabsticks, Hibiclens and Sterile Triple Swabsticks (Using Sterile Deionized Water)

Conditions
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Topical Antisepsis

Intervention / Treatment
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* Drug: CHG 2% w/v & IPA 70% v/v, swabstick (3 @ once).
* Drug: CHG 2% w/v & IPA 70% v/v swab applied sequentially
* Drug: Aqueous CHG 4% w/v applied according to mfr's directions
* Other: Sterile swabstick with sterile water (3 @ once)
* Other: Sterile swabstick with sterile water (one-at-a-time)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must read and sign an Informed Consent Form and be cooperative. Subjects must be in good general health. Subjects must have skin within 6 inches of the test site that is free of tattoos, dermatoses, abrasions, cuts, lesions, or other skin disorders. Exclusion Criteria: Use of systemic or topical antimicrobials during the 2-week pretest conditioning period. This restriction includes but is not limited to shampoos, lotions, soaps, baby powders, and materials, such as solvents, acids, or alkalis. A medical diagnosis of a physical condition, which would preclude participation such as: diabetes, hepatitis, an organ transplant, a medical surgical implant, or an immunocompromised system. Any medical condition that in the opinion of the investigator would preclude participation. Bathed in chemically treated pools or hot tubs 2 weeks prior to any microbial sampling. Used UV tanning lamps 2 weeks prior to any microbial sampling. Bathing or showering less than 48 hours prior to any microbial sampling. Known sensitivity to chlorhexidine gluconate. Known sensitivity to latex (rubber). Known sensitivity to fragrances. Pregnant or nursing. Unwillingness to fulfill the performance requirements of the study. Subjects who have completed part or all of the study will not be reentered in 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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CHG Swabstick (3 @ once)<br>Chlorhexidine gluconate (CHG) 2% w/v CHG/isopropyl alcohol (IPA) 70% v/v - 3 swabsticks applied @ same time | Drug: CHG 2% w/v & IPA 70% v/v, swabstick (3 @ once).<br>* 3 swabsticks topically applied at the same time to intact skin<br>* Other names: ChloraPrep Swabstick;|
| Experimental: CHG Swabstick sequential<br>Chlorhexidine gluconate (CHG) 2% w/v and isopropyl alcohol (IPA) 70% v/v - 3 swabsticks applied sequentially | Drug: CHG 2% w/v & IPA 70% v/v swab applied sequentially<br>* Chlorhexidine gluconate 2% w/v and isopropyl alcohol 70% v/v; 3 swabsticks applied sequentially to intact skin.<br>* Other names: ChloraPrep Swabstick;|
| Active Comparator: Hibiclens<br>Chlorhexidine gluconate (CHG) 4% w/v in an aqueous base | Drug: Aqueous CHG 4% w/v applied according to mfr's directions<br>* Chlorhexidine gluconate 4% w/v in an aqueous base applied according to mfr's directions. Step 1) 5 ml of Hibiclens applied to a sterile gauze pad. Step 2) Product applied to treatment area on intact skin for 2 minutes. Area dried with sterile towel or sterile gauze. Steps 1 and 2 repeated.<br>* Other names: Hibiclens;|
| Placebo Comparator: Sterile water swab (3 @ once)<br>Sterile swabstick wetted with sterile deionized water - 3 swabsticks applied at the same time. | Other: Sterile swabstick with sterile water (3 @ once)<br>* 3 sterile swabsticks wetted with sterile water topically applied to intact skin at the same time.<br>|
| Placebo Comparator: Sterile water swabstick (sequential)<br>Sterile swabstick wetted with sterile water--3 swabsticks applied sequentially. | Other: Sterile swabstick with sterile water (one-at-a-time)<br>* Sterile swabsticks wetted with sterile water topically applied to intact skin one-at-a-time.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| log10 Reductions From Baseline for Each Test Parameter in CFU (Colony Forming Unit)/cm2 on Inguinal and Abdominal Sites | The bacterial reductions achieved by the test products and the controls using 2 different application techniques at 10-minute and 6-hour sampling intervals for both groin and abdominal sites were evaluated. | 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