Clinical trial NCT03302988: Wound Eversion Versus Planar Closure for Face or Neck Wounds
Official title: Wound Eversion Versus Planar Closure for Wounds on the Face or Neck: a Randomized Split Wound Comparative Effectiveness Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Operative Wound
Keywords: Wound Edge Eversion
Dermal Sutures
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2017-10-05
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Each wound will have 2 treatments. The type of treatment (Type of suturing) will be chosen by random assignment
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient Observer Scar Assessment Scale (POSAS)
timeFrame: Within 3 months
measure: Incidence of sunken scars
timeFrame: Within 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis, Department of Dermatology
state: California
Study officials:
affiliation: University of California, Davis
name: Daniel Eisen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. No abstract available.
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. doi: 10.1097/01.prs.0000172982.43599.d6.