Comparison of Scar Results and Time for Closures of Scalp Defects Via Pulley Sutures or Layered Repairs

Study Overview
=================
Brief Summary
-----------------
Surgical defects on the scalp require closure via various techniques of suture placement. A traditional technique requires both dermal (deep) and epidermal (superficial) placement of sutures to close the defect; this is referred to as intermediate or complex linear repair. However, the scalp is a location with high tension, and thus the closures take an hour or longer to perform. A type of suture placement referred to as the pulley stitch requires placement of a few stitches along the defect. The pulley stitch can be used in areas of high tension to close a large defect. The purpose of this study is to compare the scar results and time taken to perform scalp closures via only pulley stitches or via intermediate/complex linear repairs. To my knowledge, no such study has been performed to compare the two techniques. Such a study would be useful in demonstrating comparable scar appearance and reduce the time to perform scalp closures.

Official Title
-----------------
A Prospective, Randomized Study to Evaluate the Efficacy of Pulley Closures Compared to Intermediate or Complex Closures for Reconstruction of Scalp Surgical Defects

Conditions
-----------------
Scar

Intervention / Treatment
-----------------
* Procedure: Pulley stitches
* Procedure: Intermediate Repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater than 18 years Ability to understand risks, benefits, and alternatives to the study and to be able to give an informed consent Lesions such as skin cancer or benign lesions on the scalp amenable to surgical excision or to MOHS surgical technique Frontal scalp defects defined as frontal hair line to crown of scalp Scalp defect size of 2cm - 8 cm Exclusion criteria: Patients who tend to form keloids or hypertrophic scars Patients with a history of scleroderma or morphea Pregnant or breast-feeding females Patients whose surgical defects require flap closures

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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intermediate/complex repair<br>This arm will have closures of scalp defects with deep and superficial suture placement. | Procedure: Intermediate Repair<br> <br> |
| Experimental: Pulley stitches<br>This arm of the study will have only pulley stitches to close the entire defect. | Procedure: Pulley stitches<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to close wound | Time it takes to close the defect in each arm; measured in minutes | Depends on case typically 4-10 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pulley, scalp defects