Wound Eversion Versus Planar Closure for Face or Neck Wounds

Study Overview
=================
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.

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

Conditions
-----------------
Operative Wound

Intervention / Treatment
-----------------
* Other: Everted closure
* Other: Planar closure


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: Each wound will have 2 treatments. The type of treatment (Type of suturing) will be chosen by random assignment
Masking: None (Open Label)


Arms and Interventions

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

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Wound Edge Eversion, Dermal Sutures