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

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: 3M
• Collaborator: Cyberderm Inc.
• Treatments: Anti-Infective Agents, Local; Chlorhexidine; Chlorhexidine gluconate; Iodine

Criteria

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