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

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.

• ChloraPrep (Drug), also known as ChloraPrep® with Tint (Scrub Teal®): 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
• DuraPrep (Drug), also known as 3M™ DuraPrep™ Surgical Solution: 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

Primary outcomes

• Drape Adhesion [30 minutes]: The peel force to remove the sample

Secondary outcomes

• 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)

Sex: All, ages: 18 Years to 65 Years, accepts healthy volunteers

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

Participant flow

Outcome results

• Drape Adhesion (Primary), Mean, grams-force: ChloraPrep 78.6 (68.0 to 89.2); DuraPrep 181.3 (165.8 to 196.8)
• Skin Assessment on Ioban, ActiGard, Steri-Drape 2 Application Sites Respectively (Secondary), Mean, units on a scale: ChloraPrep 0.67 +/- 0.52; DuraPrep 0.98 +/- 0.62

Adverse events

Limitations and caveats: All 22 subjects enrolled completed the study

• Gary L Grove, PhD, Principal investigator, Cyberderm Inc.