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

September 30, 2024 updated by: Solventum US LLC

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 30 minutes
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
Time Frame: 30 minutes
Visual assessment on skin after samples were removed. scale: 0 (no skin reaction), 4 (severe skin reaction)
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Solventum US LLC

Collaborators

3M
Cyberderm Inc.

Investigators

  • Principal Investigator: Gary L Grove, PhD, Cyberderm Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • 05-011219

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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