NCT00872638

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 28, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 31, 2009

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

June 1, 2015

Status Verified

May 1, 2015

Enrollment Period

8 years

First QC Date

March 28, 2009

Last Update Submit

May 28, 2015

Conditions

Surgical Incisions

Keywords

wound edge eversioncosmetic outcomessurgical incisions

Outcome Measures

Primary Outcomes (1)

  • Cosmetic result of surgical incision as measured by VAS scale

    1 year

Secondary Outcomes (1)

  • Cosmetic Results as measured by the Stony Brook Scar Scale

    1 year

Study Arms (2)

1

ACTIVE COMPARATOR
Procedure: Eversion

2

ACTIVE COMPARATOR
Procedure: Approximation

Interventions

EversionPROCEDURE

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

Also known as: mattress sutures
1
ApproximationPROCEDURE

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

Also known as: simple suture
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stony Brook University Medical Center

Stony Brook, New York, 11794, United States

Location

MeSH Terms

Conditions

Surgical Wound

Interventions

Automated Facial Recognition

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Biometric IdentificationBiometryStatistics as TopicEpidemiologic MethodsInvestigative TechniquesSecurity MeasuresOrganization and AdministrationHealth Services Administration

Study Officials

  • Adam Singer, MD

    Stony Brook University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
research director

Study Record Dates

First Submitted

March 28, 2009

First Posted

March 31, 2009

Study Start

January 1, 2008

Primary Completion

January 1, 2016

Study Completion

April 1, 2016

Last Updated

June 1, 2015

Record last verified: 2015-05

Locations

US(1)