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The Effect of Wound Edge Eversion on Cosmesis

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ClinicalTrials.gov Identifier: NCT00872638
Recruitment Status : Withdrawn (lack of participation)
First Posted : March 31, 2009
Last Update Posted : June 1, 2015
Sponsor:
Information provided by (Responsible Party):
Adam Singer, Stony Brook University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Surgical Incisions Procedure: Eversion Procedure: Approximation Not Applicable

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  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: The Effect of Wound Edge Eversion on Cosmesis
Study Start Date : January 2008
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: 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 Name: simple suture



Primary Outcome Measures :
  1. Cosmetic result of surgical incision as measured by VAS scale [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Cosmetic Results as measured by the Stony Brook Scar Scale [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00872638


Locations
United States, New York
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
Sponsors and Collaborators
Stony Brook University
Investigators
Principal Investigator: Adam Singer, MD Stony Brook University

Responsible Party: Adam Singer, research director, Stony Brook University
ClinicalTrials.gov Identifier: NCT00872638     History of Changes
Other Study ID Numbers: 20076828
First Posted: March 31, 2009    Key Record Dates
Last Update Posted: June 1, 2015
Last Verified: May 2015

Keywords provided by Adam Singer, Stony Brook University:
wound edge eversion
cosmetic outcomes
surgical incisions

Additional relevant MeSH terms:
Surgical Wound
Wounds and Injuries