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

Phase 4

Completed

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

Detailed Description: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
ChloraPrep	ChloraPrep	Applied ChloraPrep on the application site per manufacturer's instruction
DuraPrep	DuraPrep	Apply DuraPrep to the application site per manufacturer's instruction

Primary Outcome Measures

Name	Time	Method
Drape Adhesion	30 minutes	The peel force to remove the sample

Secondary Outcome Measures

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