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

NCT02744950 | Completed

• 1 other identifier: SK1234
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Scar

Keywords

pulley; scalp defects

Outcome Measures

Primary Outcomes (1)

• Time to close wound

  Time it takes to close the defect in each arm; measured in minutes

  Depends on case typically 4-10 minutes

Study Arms (2)

Intermediate/complex repair

ACTIVE COMPARATOR

This arm will have closures of scalp defects with deep and superficial suture placement.

Procedure: Intermediate Repair

Pulley stitches

EXPERIMENTAL

This arm of the study will have only pulley stitches to close the entire defect.

Procedure: Pulley stitches

Interventions

Pulley stitches PROCEDURE

Pulley stitches

Intermediate Repair PROCEDURE

Intermediate/complex repair

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Health System- Dermatology

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dermatologist

Study Record Dates

• First Submitted: April 14, 2016
• First Posted: April 20, 2016
• Study Start: November 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: April 20, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)