Compare Effect of Surgical Antiseptic Preparations on Incise Drape Adhesion to Skin

Study Overview
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Brief Summary
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The purpose of this study is to find out if presurgical antiseptic preparations affect how well surgical drapes adhere to skin.

Detailed Description
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Adhesive incise drapes are often used to provide a physical sterile barrier between the surrounding skin and the open wound at the beginning of a surgery. This study sought to determine the effect of presurgical skin antiseptic preparation on the adhesion of various incise drapes to the skin.

Official Title
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Prospective, Randomized Comparison of Two Presurgical Skin Antiseptic Preparations and Resultant Surgical Incise Drape Adhesion to Skin

Conditions
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Healthy

Intervention / Treatment
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* Drug: ChloraPrep
* Drug: DuraPrep


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is willing to sign the Research Consent form Healthy male or female subjects ages between 18 - 65 Subject has agreed to be and appears to be compliant with requirements of the study Subject has a back (the product application site) of sufficient size, free of blemishes to comfortably fit 18 strips of 1/2 x 3 drape samples Subject is willing to have the back clipped or shaved if it has excessive hair Exclusion Criteria: Sensitivity/allergy to adhesive products (e.g. medical tapes) Sensitivity to the antimicrobial agent iodine, povidone iodine (PVPI), isopropyl alcohol (IPA), or chlorhexidine gluconate (CHG) Allergy to seafood History of psoriasis dermatitis, or any skin condition that might be exacerbated by the action of removing adhesive materials Active dermatitis (rash), sunburn, blemishes, broken skin, cuts, and/or infection on the subject's back History of diabetes Subject is currently pregnant or thinks she may be pregnant or is nursing Subject is receiving steroid-based anti-inflammatory or immunosuppressant drug therapy Subject is taking antihistamine medication Subject has been using moisturizers or other skin contact materials on the test sites for 24 hours prior to the start of the study Subject has a back problem that prohibits him or her from lying face downward for approximately 2 hours

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ChloraPrep<br>Applied ChloraPrep on the application site per manufacturer's instruction | Drug: ChloraPrep<br>* The application sites (subjects' backs) will be prepped with ChloraPrep according to manufacturer's instruction. Samples of 3 surgical incise drapes will be applied to the prepped sites according to randomization schedule<br>* Other names: ChloraPrep® with Tint (Scrub Teal®);|
| Active Comparator: DuraPrep<br>Apply DuraPrep to the application site per manufacturer's instruction | Drug: DuraPrep<br>* The application sites (subjects' backs) will be prepped with DuraPrep according to manufacturer's instruction. Samples of 3 surgical incise drapes will be applied to the prepped sites according to randomization schedule<br>* Other names: 3M™ DuraPrep™ Surgical Solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drape Adhesion | The peel force to remove the sample | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin Assessment on Ioban, ActiGard, Steri-Drape 2 Application Sites Respectively | Visual assessment on skin after samples were removed. scale: 0 (no skin reaction), 4 (severe skin reaction) | 30 minutes |