The Effect of Wound Edge Eversion on Cosmesis

This study has suspended participant recruitment.
(lack of participation)
Sponsor:
Information provided by (Responsible Party):
Adam Singer, Stony Brook University
ClinicalTrials.gov Identifier:
NCT00872638
First received: March 28, 2009
Last updated: December 22, 2011
Last verified: December 2011
  Purpose

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 Intervention
Surgical Incisions
Procedure: Eversion
Procedure: Approximation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: The Effect of Wound Edge Eversion on Cosmesis

Resource links provided by NLM:


Further study details as provided by Stony Brook University:

Primary Outcome Measures:
  • Cosmetic result of surgical incision as measured by VAS scale [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cosmetic Results as measured by the Stony Brook Scar Scale [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 64
Study Start Date: January 2008
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Adam Singer, research director, Stony Brook University
ClinicalTrials.gov Identifier: NCT00872638     History of Changes
Other Study ID Numbers: 20076828
Study First Received: March 28, 2009
Last Updated: December 22, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 22, 2014