Wound Eversion Versus Planar Closure for Face or Neck Wounds

Operative Wound Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03302988
• Other study ID #: 803389
• Status: Completed
• Phase: N/A
• Start date: October 13, 2015
• Est. completion date: July 25, 2017

Study information

• Verified date: September 2018
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: July 25, 2017
• Est. primary completion date: July 6, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Operative Wound
• Surgical Wound
• Wounds and Injuries

Intervention

Other:
• Everted closure
Suturing technique to obtain wound eversion. Type of suturing technique at surgeon's discretion
• Planar closure
The planar side will be closed with traditional buried simple closure and running cuticular sutures

Locations

Country	Name	City	State
United States	University of California, Davis, Department of Dermatology	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Incidence of sunken scars	The incidence of sunken scars or elevated scaring on each treatment side will also be determined	Within 3 months