A Prospective, Randomized Study to Evaluate the Efficacy of Pulley Closures Compared to Intermediate or Complex Closures for Reconstruction of Scalp Surgical Defects
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Henry Ford Health System
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- Time to close wound
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Intermediate/complex repair
This arm will have closures of scalp defects with deep and superficial suture placement.
Intervention: Intermediate Repair (Procedure)
Pulley stitches
This arm of the study will have only pulley stitches to close the entire defect.
Intervention: Pulley stitches (Procedure)
Outcomes
Primary Outcomes
Time to close wound
Time Frame: Depends on case typically 4-10 minutes
Time it takes to close the defect in each arm; measured in minutes
Secondary Outcomes
No secondary outcomes reported
Investigators
David M. Ozog
Dermatologist
Henry Ford Health System