Closure Techniques and Scar Appearance

Study 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.

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

Conditions
-----------------
Wound Closure Techniques

Intervention / Treatment
-----------------
* Procedure: Running polypropylene closure
* Procedure: Tissue Adhesive (Derma-Bond)
* Procedure: Subcuticular polyglactin-910 combined with tissue adhesive


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Running polypropylene closure<br>Half of every linear wound will be closed with running polypropylene sutures. This technique is Standard of Care. | Procedure: Running polypropylene closure<br>* Half of every wound will be closed with Standard of Care running polypropylene sutures<br>|
| Experimental: Tissue Adhesive (Derma-Bond)<br>The experimental half of the wound will be randomized to receive closure with tissue adhesive alone. | Procedure: Tissue Adhesive (Derma-Bond)<br>* Approximately half of wounds will be randomized to be closed with tissue adhesive.<br>|
| Experimental: Subcuticular polyglactin-910 combined with tissue adhesive<br>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<br>* Approximately half of the experimental wounds will be randomized to be closed with a combination of subcuticular polyglactin-910 and tissue adhesive.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound Healing | 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. | 10 day/3 weeks and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dehiscence | The rate of dehiscence observed will be noted and recorded by the treating physicians. | 10 days/3 weeks and 3 months | 
| Subject Satisfaction | 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. | 10 days/3 weeks and 3 months | 
| Adverse Events | The treating physicians will note occurrence and extent of any adverse events associated with either type of epidermal closure. | 10 days/3 weeks and 3 months |