The Effect of Wound Edge Eversion on Cosmesis | NCT00872638

Studies
The Effect of Wound Edge Eversion on Cosmesis

NCT00872638

Sponsor

Stony Brook University

Status

Withdrawn

Last Update Posted

Jun 1, 2015Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Surgical Incisions

Interventions

Eversion
Approximation

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

lack of participation

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Jan 2016Estimated

Completion Date

Apr 2016Estimated

First Submitted Date

Mar 28, 2009

First Submission Date that Met QC Criteria

Mar 30, 2009

First Posted Date

Mar 31, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 28, 2015

Last Update Posted Date

Jun 1, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator		Procedure: Eversion
2	Active Comparator		Procedure: Approximation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Eversion	Procedure	Surgical incisions will be closed in such a manner so as to evert the wound edges.	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cosmetic result of surgical incision as measured by VAS scale		1 year

Secondary Outcomes

Measure	Description	Time Frame
Cosmetic Results as measured by the Stony Brook Scar Scale		1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Adam Singer, MD	Stony Brook University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stony Brook University Medical Center		Stony Brook	New York	11794	United States

ID	Term
D000072836	Surgical Wound

ID	Term
D014947	Wounds and Injuries

Intervention Browse Module

MeSH Terms

ID	Term
D000086762	Automated Facial Recognition

Ancestor Terms

ID	Term
D056667	Biometric Identification
D001699	Biometry
D013223	Statistics as Topic
D004812	Epidemiologic Methods

Browse Leaves

Not provided

Browse Branches

Not provided