Wound Eversion Versus Planar Closure for Face or Neck Wounds

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

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.

Study Overview

• Status: Completed
• Conditions: Operative Wound
• Intervention / Treatment: Other: Everted closure; Other: Planar closure

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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95816
      • University of California, Davis, Department of Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: Everted closure; Suturing technique to obtain wound eversion. Type of suturing technique at surgeon's discretion
Active Comparator: Planar closure; The planar side of the same wond will be closed with traditional buried simple closure and running cuticular sutures	Other: Planar closure; The planar side will be closed with traditional buried simple closure and running cuticular sutures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Observer Scar Assessment Scale (POSAS)	The primary endpoint will be the score of two blinded reviewers using the physician observer assessment score at a three-month assessment visit.	Within 3 months
Incidence of sunken scars	The incidence of sunken scars or elevated scaring on each treatment side will also be determined	Within 3 months

Collaborators and Investigators

• Sponsor: University of California, Davis
• Investigators: Principal Investigator: Daniel Eisen, MD, University of California, Davis

Publications and helpful links

General Publications

• van de Kar AL, Corion LU, Smeulders MJ, Draaijers LJ, van der Horst CM, van Zuijlen PP. Reliable and feasible evaluation of linear scars by the Patient and Observer Scar Assessment Scale. Plast Reconstr Surg. 2005 Aug;116(2):514-22. doi: 10.1097/01.prs.0000172982.43599.d6.
• Kappel S, Kleinerman R, King TH, Sivamani R, Taylor S, Nguyen U, Eisen DB. Does wound eversion improve cosmetic outcome?: Results of a randomized, split-scar, comparative trial. J Am Acad Dermatol. 2015 Apr;72(4):668-73. doi: 10.1016/j.jaad.2014.11.032. Epub 2015 Jan 23.
• Trufant JW, Leach BC. Commentary: Wound edge eversion: surgical dogma or diversion? J Am Acad Dermatol. 2015 Apr;72(4):681-2. doi: 10.1016/j.jaad.2014.09.046. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2015
• Primary Completion (Actual): July 6, 2016
• Study Completion (Actual): July 25, 2017

Study Registration Dates

• First Submitted: October 2, 2017
• First Submitted That Met QC Criteria: October 2, 2017
• First Posted (Actual): October 5, 2017

Study Record Updates

• Last Update Posted (Actual): September 24, 2018
• Last Update Submitted That Met QC Criteria: September 20, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Wound Edge Eversion; Dermal Sutures
• Additional Relevant MeSH Terms: Wounds and Injuries; Surgical Wound
• Other Study ID Numbers: 803389

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No