Closure Techniques and Scar Appearance

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by Northwestern University
Sponsor:
Information provided by (Responsible Party):
Murad Alam, Northwestern University
ClinicalTrials.gov Identifier:
NCT01352533
First received: April 29, 2011
Last updated: February 21, 2014
Last verified: February 2014
  Purpose

The goal of this study is to assess whether wound closure with skin adhesive or running stitches combined with skin adhesive will be superior to standard wound sutures. This is a split-wound study that will compare two methods of skin closure within one standard closure technique, thereby providing an internal control of running stitches within each wound. The investigators plan to measure outcomes by assessing for scar appearance, the incidence of wound opening, scar elasticity and subject satisfaction.


Condition Intervention
Wound Closure Techniques
Procedure: Running polypropylene closure
Procedure: Tissue Adhesive (Derma-Bond)
Procedure: Subcuticular polyglactin-910 combined with tissue adhesive

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Prospective Trial of 2-Octyl Cyanoacrylate (Derma-Bond) Tissue Adhesive Versus Running Subcuticular Suture Combined With Tissue Adhesive Versus Epidermal Sutures in Dermatologic Surgery Procedures of the Head and Neck

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Wound Healing [ Time Frame: 10 day/3 weeks and 3 months ] [ Designated as safety issue: No ]
    The primary outcome measure of this study will be wound healing. This outcome will be assessed by the blinded observers, subject ratings and Cutometer measurements of scar elasticity. Two double-blinded dermatologists will be asked to rate the scars according to the objective scar scales at the 10 day/ 3 week and 3 month follow-up exams.


Secondary Outcome Measures:
  • Dehiscence [ Time Frame: 10 days/3 weeks and 3 months ] [ Designated as safety issue: Yes ]
    The rate of dehiscence observed will be noted and recorded by the treating physicians.

  • Subject Satisfaction [ Time Frame: 10 days/3 weeks and 3 months ] [ Designated as safety issue: No ]
    The subjects will fill out the VAS to evaluate their overall assessment of their scar, any associated pruritus and pain. The subjects will also fill out a Subject Satisfaction Survey to evaluate subject preference for closure.

  • Adverse Events [ Time Frame: 10 days/3 weeks and 3 months ] [ Designated as safety issue: Yes ]
    The treating physicians will note occurrence and extent of any adverse events associated with either type of epidermal closure.


Estimated Enrollment: 75
Study Start Date: March 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Running polypropylene closure
Half of every linear wound will be closed with running polypropylene sutures. This technique is Standard of Care.
Procedure: Running polypropylene closure
Half of every wound will be closed with Standard of Care running polypropylene sutures
Experimental: Tissue Adhesive (Derma-Bond)
The experimental half of the wound will be randomized to receive closure with tissue adhesive alone.
Procedure: Tissue Adhesive (Derma-Bond)
Approximately half of wounds will be randomized to be closed with tissue adhesive.
Experimental: Subcuticular polyglactin-910 combined with tissue adhesive
The experimental half of the wound will be randomized to receive closure with running subcuticular polyglactin-910 combined with tissue adhesive.
Procedure: Subcuticular polyglactin-910 combined with tissue adhesive
Approximately half of the experimental wounds will be randomized to be closed with a combination of subcuticular polyglactin-910 and tissue adhesive.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18 and over
  • Linear closures on the head and neck, at least 3cm in length
  • The subjects are in good health
  • The subject has the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator.

Exclusion Criteria:

  • Under 18 years of age
  • Pregnancy or Lactation
  • Subjects who are unable to understand the protocol or to give informed consent
  • Subjects with mental illness
  • Defects on the scalp
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01352533

Contacts
Contact: Emily Poon 312-695-4761 research.nuderm@northwestern.edu

Locations
United States, Illinois
Northwestern University Department of Dermatology Not yet recruiting
Chicago, Illinois, United States, 60611
Contact: Emily Poon    312-695-4761    research.nuderm@northwestern.edu   
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Murad Alam, MD Northwestern University
  More Information

No publications provided

Responsible Party: Murad Alam, Associate Professor of Dermatology, Northwestern University
ClinicalTrials.gov Identifier: NCT01352533     History of Changes
Other Study ID Numbers: STU38040
Study First Received: April 29, 2011
Last Updated: February 21, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on July 31, 2014