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

Prospective, Randomized Comparison of Two Presurgical Skin Antiseptic Preparations and Resultant Surgical Incise Drape Adhesion to Skin

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: ChloraPrep; Drug: DuraPrep

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Broomall, Pennsylvania, United States, 19008
      • cyberDERM Clinical Studies

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ChloraPrep; Applied ChloraPrep on the application site per manufacturer's instruction	Drug: 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; Other Names: ChloraPrep® with Tint (Scrub Teal®)
Active Comparator: DuraPrep; Apply DuraPrep to the application site per manufacturer's instruction	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; Other Names: 3M™ DuraPrep™ Surgical Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drape Adhesion	The peel force to remove the sample	30 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Solventum US LLC
• Collaborators: 3M; Cyberderm Inc.
• Investigators: Principal Investigator: Gary L Grove, PhD, Cyberderm Inc.

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: February 4, 2011
• First Submitted That Met QC Criteria: February 4, 2011
• First Posted (Estimated): February 7, 2011

Study Record Updates

• Last Update Posted (Actual): October 2, 2024
• Last Update Submitted That Met QC Criteria: September 30, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix; Tissue Adhesions
• Other Study ID Numbers: 05-011219