Trial of Techniques for Umbilical Reconstruction

September 8, 2023 updated by: NYU Langone Health

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • New York University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Round Procedure
umbilicoplasty technique
Procedure: Round Procedure Umbilicoplasty
Umbilicoplasty surgery (belly button reshaping) is performed using the "Round Procedure"
Active Comparator: "Scarless" round procedure
umbilicoplasty technique
Procedure: Scarless" round procedure
Umbilicoplasty surgery (belly button reshaping) is performed using the "Scarless" round procedure
Active Comparator: "Inverted U" procedure
umbilicoplasty technique
Procedure: "Inverted U" Procedure
Umbilicoplasty surgery (belly button reshaping) is performed using the "Inverted U" Procedure
Active Comparator: "Inverted V" procedure
umbilicoplasty technique
Procedure: "Inverted V"Procedure
Umbilicoplasty surgery (belly button reshaping) is performed using the "Inverted V" Procedure
Active Comparator: Y deepithelialized" procedure
umbilicoplasty technique
Procedure: "Y deepithelialized" Procedure
Umbilicoplasty surgery (belly button reshaping) is performed using the "Y deepithelialized" procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in measurement of patient assessment post-operative and pre-operative, using a VAS survey results with a positive result indicating a favorable outcome
Time Frame: Baseline, 12 Weeks
Baseline, 12 Weeks
Assessment of inter-rater reliability among physicians in the assessment of the aesthetic outcomes of umbilical reconstruction.
Time Frame: 12 Weeks
12 Weeks
Comparison of aesthetic outcomes of umbilical reconstruction using five accepted techniques for umbilicoplasty following abdominoplasty or abdominally-based free tissue transfer (TRAM/DIEP flaps).
Time Frame: 12 Weeks
12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Investigators

  • Principal Investigator: VIshal Thanik, MD, New York University Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

August 1, 2023

Study Completion (Actual)

August 1, 2023

Study Registration Dates

First Submitted

March 8, 2016

First Submitted That Met QC Criteria

March 23, 2016

First Posted (Estimated)

March 30, 2016

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 8, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 15-00480

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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