Wound Eversion Versus Planar Closure for Face or Neck Wounds

NCT ID: NCT03302988

Last Updated: 2018-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-13

Study Completion Date

2017-07-25

Brief Summary

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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

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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.

Conditions

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Operative Wound

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Each wound will have 2 treatments. The type of treatment (Type of suturing) will be chosen by random assignment
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Everted closure

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

Group Type EXPERIMENTAL

Everted closure

Intervention Type OTHER

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

Planar closure

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

Group Type ACTIVE_COMPARATOR

Planar closure

Intervention Type OTHER

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

Interventions

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Everted closure

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

Intervention Type OTHER

Planar closure

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel Eisen, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

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University of California, Davis, Department of Dermatology

Sacramento, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 25619206 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25773410 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16079683 (View on PubMed)

Other Identifiers

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803389

Identifier Type: -

Identifier Source: org_study_id

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