NCT03302988

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 13, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 6, 2016

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 2, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 5, 2017

Completed
Last Updated

September 24, 2018

Status Verified

September 1, 2018

Enrollment Period

9 months

First QC Date

October 2, 2017

Last Update Submit

September 20, 2018

Conditions

Operative Wound

Keywords

Wound Edge EversionDermal Sutures

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Everted closure

EXPERIMENTAL

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

Planar closure

ACTIVE COMPARATOR

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

Other: Planar closure

Interventions

Everted closureOTHER

Suturing technique to obtain wound eversion. Type of suturing technique at surgeon's discretion

Everted closure
Planar closureOTHER

The planar side will be closed with traditional buried simple closure and running cuticular sutures

Planar closure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Davis, Department of Dermatology

Sacramento, California, 95816, United States

Location

Related 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.

    PMID: 25619206BACKGROUND

  • 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.

    PMID: 25773410BACKGROUND

  • 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.

    PMID: 16079683BACKGROUND

MeSH Terms

Conditions

Surgical Wound

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Daniel Eisen, MD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
FACTORIAL
Model Details: Each wound will have 2 treatments. The type of treatment (Type of suturing) will be chosen by random assignment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2017

First Posted

October 5, 2017

Study Start

October 13, 2015

Primary Completion

July 6, 2016

Study Completion

July 25, 2017

Last Updated

September 24, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)