Trial of Techniques for Umbilical Reconstruction

NCT ID: NCT02723409

Last Updated: 2023-09-13

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

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2023-08-31

Brief Summary

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The primary objective of the study will be to determine which of five traditionally used umbilical reconstructive techniques offers superior aesthetic results. Additionally, secondary objectives of post-operative complications such as hypertrophic scar formation will also be measured.

Detailed Description

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This is a five arm, prospective, randomized, trial. Patients undergoing abdominoplasty or abdominally-based free tissue transfer (TRAM/DIEP flaps) at NYU Medical Center will be randomly assigned to receive one of five conventionally used umbilicoplasty techniques during the course of their surgery:

1. Round procedure
2. "Scarless" round procedure
3. "Inverted u" procedure
4. "Inverted v" procedure, and
5. "Y deepithelialized" procedure

As there has not yet been a superiority or inferiority comparison of these five methods, no patient will be receiving substandard care by randomization to one of the five procedures.

Conditions

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Umbilicoplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Round Procedure

umbilicoplasty technique

Group Type ACTIVE_COMPARATOR

Round Procedure Umbilicoplasty

Intervention Type PROCEDURE

Umbilicoplasty surgery (belly button reshaping) is performed using the "Round Procedure"

"Scarless" round procedure

umbilicoplasty technique

Group Type ACTIVE_COMPARATOR

Scarless" round procedure

Intervention Type PROCEDURE

Umbilicoplasty surgery (belly button reshaping) is performed using the "Scarless" round procedure

"Inverted U" procedure

umbilicoplasty technique

Group Type ACTIVE_COMPARATOR

"Inverted U" Procedure

Intervention Type PROCEDURE

Umbilicoplasty surgery (belly button reshaping) is performed using the "Inverted U" Procedure

"Inverted V" procedure

umbilicoplasty technique

Group Type ACTIVE_COMPARATOR

"Inverted V"Procedure

Intervention Type PROCEDURE

Umbilicoplasty surgery (belly button reshaping) is performed using the "Inverted V" Procedure

Y deepithelialized" procedure

umbilicoplasty technique

Group Type ACTIVE_COMPARATOR

"Y deepithelialized" Procedure

Intervention Type PROCEDURE

Umbilicoplasty surgery (belly button reshaping) is performed using the "Y deepithelialized" procedure

Interventions

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Round Procedure Umbilicoplasty

Umbilicoplasty surgery (belly button reshaping) is performed using the "Round Procedure"

Intervention Type PROCEDURE

Scarless" round procedure

Umbilicoplasty surgery (belly button reshaping) is performed using the "Scarless" round procedure

Intervention Type PROCEDURE

"Inverted U" Procedure

Umbilicoplasty surgery (belly button reshaping) is performed using the "Inverted U" Procedure

Intervention Type PROCEDURE

"Inverted V"Procedure

Umbilicoplasty surgery (belly button reshaping) is performed using the "Inverted V" Procedure

Intervention Type PROCEDURE

"Y deepithelialized" Procedure

Umbilicoplasty surgery (belly button reshaping) is performed using the "Y deepithelialized" procedure

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Signed Informed Consent Form
* Female patients undergoing abdominoplasty or abdominally-based free tissue transfer (TRAM/DIEP flaps)

Exclusion Criteria

* Patients with prior history of umbilicoplasty
* History of keloid formation
* Active smokers
* Body Mass Index (BMI) over 40
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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VIshal Thanik, MD

Role: PRINCIPAL_INVESTIGATOR

New York University Medical School

Locations

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New York University School of Medicine

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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15-00480

Identifier Type: -

Identifier Source: org_study_id

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