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Wound Eversion Versus Planar Closure for Face or Neck Wounds

Primary Purpose

Operative Wound

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Everted closure
Planar closure
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Operative Wound focused on measuring Wound Edge Eversion, Dermal Sutures

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California, Davis, Department of Dermatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Everted closure

Planar closure

Arm Description

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

The planar side of the same wond will be closed with traditional buried simple closure and running cuticular sutures

Outcomes

Primary Outcome Measures

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.
Incidence of sunken scars
The incidence of sunken scars or elevated scaring on each treatment side will also be determined

Secondary Outcome Measures

Full Information

First Posted
October 2, 2017
Last Updated
September 20, 2018
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT03302988
Brief Title
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

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
October 13, 2015 (Actual)
Primary Completion Date
July 6, 2016 (Actual)
Study Completion Date
July 25, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Operative Wound
Keywords
Wound Edge Eversion, Dermal Sutures

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
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)
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Everted closure
Arm Type
Experimental
Arm Description
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
Arm Title
Planar closure
Arm Type
Active Comparator
Arm Description
The planar side of the same wond will be closed with traditional buried simple closure and running cuticular sutures
Intervention Type
Other
Intervention Name(s)
Everted closure
Intervention Description
Suturing technique to obtain wound eversion. Type of suturing technique at surgeon's discretion
Intervention Type
Other
Intervention Name(s)
Planar closure
Intervention Description
The planar side will be closed with traditional buried simple closure and running cuticular sutures
Primary Outcome Measure Information:
Title
Patient Observer Scar Assessment Scale (POSAS)
Description
The primary endpoint will be the score of two blinded reviewers using the physician observer assessment score at a three-month assessment visit.
Time Frame
Within 3 months
Title
Incidence of sunken scars
Description
The incidence of sunken scars or elevated scaring on each treatment side will also be determined
Time Frame
Within 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Eisen, MD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Davis, Department of Dermatology
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25619206
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.
Results Reference
background
PubMed Identifier
25773410
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.
Results Reference
background
PubMed Identifier
16079683
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.
Results Reference
background

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Wound Eversion Versus Planar Closure for Face or Neck Wounds

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