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OpenTrials
Completed

NCT Number: NCT03302988

Wound Eversion Versus Planar Closure for Face or Neck Wounds

The aim of this study is to determine whether wound edge eversion, achieved by careful placement of dermal sutures, improves the cosmetic outcome of operative wounds closed on the head or neck.

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Key information

Conditions

Operative Wound Surgical Wound Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Davis, Department of Dermatology

Sacramento, California, 95816, United States

About this study

It has been established that as wounds heal, the resultant tissue remodeling results in wound contracture. Surgeons are taught that by everting wounds' edges with well-placed dermal sutures, there is less depression of the resultant scar. A prior study conducted by us at this center found that wound eversion was not associated with better cosmetic outcome (1). However, it was noted that most of the procedures were performed off the head and neck, places where the effects of eversion were thought to be most beneficial (2) Thus our goal is to now study the effects of eversion exclusively on the face and neck.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Over 18 years of age
  • Able to give informed consent themselves
  • Patient scheduled for cutaneous surgical procedure with predicted linear closure on the face or neck
  • Willing to return for follow up visits

Exclusion criteria

  • Mentally handicapped
  • Unable to understand written and oral English
  • Incarceration
  • Under 18 years of age
  • Pregnant Women
  • Adults unable to consent
  • Individuals who are not yet adults (infants, children, teenagers)
  • Pregnant women
  • Prisoners

Treatment and study plan

Everted closure

Other

Suturing technique to obtain wound eversion. Type of suturing technique at surgeon's discretion

Planar closure

Other

The planar side will be closed with traditional buried simple closure and running cuticular sutures

Primary outcomes

  1. Patient Observer Scar Assessment Scale (POSAS)

    Time frame: Within 3 months

    The primary endpoint will be the score of two blinded reviewers using the physician observer assessment score at a three-month assessment visit.

  2. Incidence of sunken scars

    Time frame: Within 3 months

    The incidence of sunken scars or elevated scaring on each treatment side will also be determined

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

Wound Eversion Versus Planar Closure for Wounds on the Face or Neck: a Randomized Split Wound Comparative Effectiveness Trial

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Oct 5, 2017
Registry last updated
Sep 24, 2018

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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