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

Scar Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02744950
• Other study ID #: SK1234
• Status: Completed
• Phase: N/A
• First received: April 14, 2016
• Last updated: April 15, 2016
• Start date: November 2013
• Est. completion date: May 2015

Study information

• Verified date: April 2016
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age greater than 18 years

2. Ability to understand risks, benefits, and alternatives to the study and to be able to give an informed consent

3. Lesions such as skin cancer or benign lesions on the scalp amenable to surgical excision or to MOHS surgical technique

4. Frontal scalp defects defined as frontal hair line to crown of scalp

5. Scalp defect size of 2cm - 8 cm

Exclusion criteria:

1. Patients who tend to form keloids or hypertrophic scars

2. Patients with a history of scleroderma or morphea

3. Pregnant or breast-feeding females

4. Patients whose surgical defects require flap closures

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Scar

Intervention

Procedure:
• Pulley stitches

• Intermediate Repair

Locations

Country	Name	City	State
United States	Henry Ford Health System- Dermatology	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to close wound	Time it takes to close the defect in each arm; measured in minutes	Depends on case typically 4-10 minutes	No