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

April 29, 2011
February 21, 2014
March 2014
December 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01352533 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Closure Techniques and Scar Appearance
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

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Wound Closure Techniques
  • Procedure: Running polypropylene closure
    Half of every wound will be closed with Standard of Care running polypropylene sutures
  • Procedure: Tissue Adhesive (Derma-Bond)
    Approximately half of wounds will be randomized to be closed 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.
  • Active Comparator: Running polypropylene closure
    Half of every linear wound will be closed with running polypropylene sutures. This technique is Standard of Care.
    Intervention: Procedure: Running polypropylene closure
  • Experimental: Tissue Adhesive (Derma-Bond)
    The experimental half of the wound will be randomized to receive closure with tissue adhesive alone.
    Intervention: Procedure: Tissue Adhesive (Derma-Bond)
  • 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.
    Intervention: Procedure: Subcuticular polyglactin-910 combined with tissue adhesive
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
75
December 2015
December 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact: Emily Poon 312-695-4761 research.nuderm@northwestern.edu
United States
 
NCT01352533
STU38040
Yes
Murad Alam, Northwestern University
Northwestern University
Not Provided
Principal Investigator: Murad Alam, MD Northwestern University
Northwestern University
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP