Closure Techniques and Scar Appearance
|ClinicalTrials.gov Identifier: NCT01352533|
Recruitment Status : Withdrawn
First Posted : May 12, 2011
Last Update Posted : October 7, 2016
|Condition or disease||Intervention/treatment||Phase|
|Wound Closure Techniques||Procedure: Running polypropylene closure Procedure: Tissue Adhesive (Derma-Bond) Procedure: Subcuticular polyglactin-910 combined with tissue adhesive||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||July 2017|
|Estimated Study Completion Date :||July 2017|
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.
- Wound Healing [ Time Frame: 10 day/3 weeks and 3 months ]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.
- Dehiscence [ Time Frame: 10 days/3 weeks and 3 months ]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 ]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 ]The treating physicians will note occurrence and extent of any adverse events associated with either type of epidermal closure.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01352533
|Principal Investigator:||Murad Alam, MD||Northwestern University|