Compare Effect of Surgical Antiseptic Preparations on Incise Drape Adhesion to Skin (NCT01290978) | Clinical Trial Compass
CompletedPhase 4
Compare Effect of Surgical Antiseptic Preparations on Incise Drape Adhesion to Skin
United States22 participantsStarted 2010-02
Plain-language summary
The purpose of this study is to find out if presurgical antiseptic preparations affect how well surgical drapes adhere to skin.
Who can participate
Age range18 Years – 65 Years
SexALL
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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