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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-03-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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ChloraPrep

Applied ChloraPrep on the application site per manufacturer's instruction

Group Type ACTIVE_COMPARATOR

ChloraPrep

Intervention Type DRUG

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

Apply DuraPrep to the application site per manufacturer's instruction

Group Type ACTIVE_COMPARATOR

DuraPrep

Intervention Type DRUG

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

Interventions

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ChloraPrep

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

Intervention Type DRUG

DuraPrep

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

Intervention Type DRUG

Other Intervention Names

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ChloraPrep® with Tint (Scrub Teal®) 3M™ DuraPrep™ Surgical Solution

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes