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

NCT01290978 | Completed Phase 4 Results

• 1 other identifier: 05-011219
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Drape Adhesion

  The peel force to remove the sample

  30 minutes

Secondary Outcomes (1)

• Skin Assessment on Ioban, ActiGard, Steri-Drape 2 Application Sites Respectively

  30 minutes

Study Arms (2)

ChloraPrep

ACTIVE COMPARATOR

Applied ChloraPrep on the application site per manufacturer's instruction

Drug: ChloraPrep

DuraPrep

ACTIVE COMPARATOR

Apply DuraPrep to the application site per manufacturer's instruction

Drug: DuraPrep

Interventions

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

Also known as: ChloraPrep® with Tint (Scrub Teal®)

ChloraPrep

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

Also known as: 3M™ DuraPrep™ Surgical Solution

DuraPrep

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Solventum US LLC: lead
• Cyberderm Inc.: collaborator
• 3M: collaborator

Study Sites (1)

cyberDERM Clinical Studies

Broomall, Pennsylvania, 19008, United States

Location

MeSH Terms

Interventions

DuraPrep

Limitations and Caveats

All 22 subjects enrolled completed the study

Results Point of Contact

• Title: Dr. Gary Grove
• Organization: cyberDERM Clinical Studies

610-325-0112

Study Officials

• Gary L Grove, PhD

  Cyberderm Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2011
• First Posted: February 7, 2011
• Study Start: February 1, 2010
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: October 2, 2024
• Results First Posted: March 5, 2013

Record last verified: 2024-09

Locations

US (1)