The Effect of Wound Edge Eversion on Cosmesis

Surgical Incisions Clinical Trial

Official title:

The Effect of Wound Edge Eversion on Cosmesis

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00872638
• Other study ID #: 20076828
• Status: Withdrawn
• Phase: N/A
• First received: March 28, 2009
• Last updated: May 28, 2015
• Start date: January 2008
• Est. completion date: April 2016

Study information

• Verified date: May 2015
• Source: Stony Brook University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Surgical Incisions

Intervention

Procedure:
• Eversion
Surgical incisions will be closed in such a manner so as to evert the wound edges.
• Approximation
Surgical incisions will be closed in such a manner so that wound edges are approximated exactly, i.e. without eversion.

Locations

Country	Name	City	State
United States	Stony Brook University Medical Center	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Stony Brook University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cosmetic result of surgical incision as measured by VAS scale		1 year	No
Secondary	Cosmetic Results as measured by the Stony Brook Scar Scale		1 year	No