The Effect of Wound Edge Eversion on Cosmesis

May 28, 2015 updated by: Adam Singer, Stony Brook University
Aesthetic appearance of repaired incisions is very important to surgical patients. It has been stated that if the edges of a wound are closed in such a manner that will result in eversion, or pouting of the edges that the end cosmetic result will be superior when compared to wound edges that are simply approximated. The purpose of this study is to compare cosmetic outcomes of incisions that are closed with everted edges to those in which the edges are simply approximated.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Surgical incisions will be split into two halfs and each half will be randomized to standard or everting sutures. 3 months later the cosmetic outcome of the healed wounds will be determined using a validated scar evaluation scale.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Stony Brook, New York, United States, 11794
        • Stony Brook University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age over 18.
  • able to consent.
  • scheduled for elective plastic or cardiothoracic surgery.

Exclusion Criteria:

  • history of keloids, hypertrophic scarring, diabetes, or peripheral vascular disease.
  • those requiring systemic steroids or undergoing chemotherapy, and those unable or unwilling to consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
Procedure: Eversion
Surgical incisions will be closed in such a manner so as to evert the wound edges.
Other Names:
  • mattress sutures
ACTIVE_COMPARATOR: 2
Procedure: Approximation
Surgical incisions will be closed in such a manner so that wound edges are approximated exactly, i.e. without eversion.
Other Names:
  • simple suture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cosmetic result of surgical incision as measured by VAS scale
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Cosmetic Results as measured by the Stony Brook Scar Scale
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stony Brook University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (ANTICIPATED)

January 1, 2016

Study Completion (ANTICIPATED)

April 1, 2016

Study Registration Dates

First Submitted

March 28, 2009

First Submitted That Met QC Criteria

March 30, 2009

First Posted (ESTIMATE)

March 31, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

June 1, 2015

Last Update Submitted That Met QC Criteria

May 28, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20076828

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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