Wound Eversion Versus Planar Closure for Face or Neck Wounds

Not Applicable

Completed

• Conditions: Operative Wound
• Interventions: Other: Everted closure; Other: Planar closure

• Registration Number: NCT03302988
• Lead Sponsor: University of California, Davis

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-10-13
• Primary Completion: 2016-07-06
• Study Completion: 2017-07-25
• Study First Submitted: 2017-10-02
• Study First Submitted QC: 2017-10-02
• Study First Posted: 2017-10-05
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-20
• Last Update Posted: 2018-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Everted closure	Everted closure	Wound eversion will be achieved through buried vertical mattress suture or cuticular suture based on surgeon's preference, either buried vertical mattress suture or cuticular sutures
Planar closure	Planar closure	The planar side of the same wond will be closed with traditional buried simple closure and running cuticular sutures

Primary Outcome Measures

Name	Time	Method
Patient Observer Scar Assessment Scale (POSAS)	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.
Incidence of sunken scars	Within 3 months	The incidence of sunken scars or elevated scaring on each treatment side will also be determined

Trial Locations

Locations (1)

University of California, Davis, Department of Dermatology; 🇺🇸 Sacramento, California, United States