The Effect of Wound Edge Eversion on Cosmesis

NCT ID: NCT00872638

Last Updated: 2015-06-01

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2016-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Surgical Incisions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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1

Group Type ACTIVE_COMPARATOR

Eversion

Intervention Type PROCEDURE

Surgical incisions will be closed in such a manner so as to evert the wound edges.

2

Group Type ACTIVE_COMPARATOR

Approximation

Intervention Type PROCEDURE

Surgical incisions will be closed in such a manner so that wound edges are approximated exactly, i.e. without eversion.

Interventions

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Eversion

Surgical incisions will be closed in such a manner so as to evert the wound edges.

Intervention Type PROCEDURE

Approximation

Surgical incisions will be closed in such a manner so that wound edges are approximated exactly, i.e. without eversion.

Intervention Type PROCEDURE

Other Intervention Names

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mattress sutures simple suture

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stony Brook University

OTHER

Sponsor Role lead

Responsible Party

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Adam Singer

research director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Adam Singer, MD

Role: PRINCIPAL_INVESTIGATOR

Stony Brook University

Locations

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Stony Brook University Medical Center

Stony Brook, New York, United States

Site Status

Countries

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United States

Other Identifiers

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20076828

Identifier Type: -

Identifier Source: org_study_id

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