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Completed

NCT Number: NCT01290978

Compare Effect of Surgical Antiseptic Preparations on 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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

cyberDERM Clinical Studies

Broomall, Pennsylvania, 19008, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chloraprep

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

Other names: ChloraPrep® with Tint (Scrub Teal®)

DuraPrep

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

Other names: 3M™ DuraPrep™ Surgical Solution

Primary outcomes

  1. Drape Adhesion

    Time frame: 30 minutes

    The peel force to remove the sample

Secondary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Solventum US LLC

Industry

Collaborators

  • 3M
  • Cyberderm Inc.

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Feb 7, 2011
Registry last updated
Oct 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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