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Completed

NCT Number: NCT02744950

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

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.

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Key information

Conditions

Scar Cicatrix Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Henry Ford Health System- Dermatology

Detroit, Michigan, 48202, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pulley stitches

Procedure

Intermediate Repair

Procedure

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Apr 20, 2016
Registry last updated
Apr 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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