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

Completed · Phase 4

Conditions studied: Healthy

In brief

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

Key facts

Study ID

NCT01290978

Run by

Solventum US LLC

People needed

22

Starts

2010-02-01

Expected to finish

2010-03-01

Last updated by the study team

2024-10-02

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• cyberDERM Clinical Studies — Broomall, Pennsylvania, United States

Full record on ClinicalTrials.gov

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