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

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

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 Overview

• Status: Completed
• Conditions: Scar
• Intervention / Treatment: Procedure: Intermediate Repair; Procedure: Pulley stitches

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System- Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Henry Ford Health System

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: April 14, 2016
• First Submitted That Met QC Criteria: April 15, 2016
• First Posted (Estimate): April 20, 2016

Study Record Updates

• Last Update Posted (Estimate): April 20, 2016
• Last Update Submitted That Met QC Criteria: April 15, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: pulley; scalp defects
• Other Study ID Numbers: SK1234

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Via a research paper