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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Wound Closure Techniques
- Sponsor
- Northwestern University
- Primary Endpoint
- Wound Healing
- Status
- Withdrawn
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Investigators
Murad Alam
Associate Professor of Dermatology
Northwestern University
Eligibility 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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Dehiscence(10 days/3 weeks and 3 months)
- Adverse Events(10 days/3 weeks and 3 months)
- Subject Satisfaction(10 days/3 weeks and 3 months)