Trial of Techniques for Umbilical Reconstruction



Status:Recruiting
Healthy:No
Age Range:18 - 65
Updated:12/8/2018
Start Date:January 2016
End Date:March 2021
Contact:Tiffany Drummond
Email:drummt02@nyumc.org

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Trial Summary
Trial Overview
Inclusion Criteria

Umbilicoplasty: A Randomized Controlled Trial of Techniques for Umbilical Reconstruction Following Abdominoplasty and Abdominally-based Free Tissue Transfer

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.

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.

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
We found this trial at
1
site
New York University School of Medicine
550 1st Ave
New York, New York 10016
(212) 263-7300
Principal Investigator: Vishal Thanik, MD
New York University School of Medicine NYU School of Medicine has a proud history that...
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New York, NY
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