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Trial of Techniques for Umbilical Reconstruction

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ClinicalTrials.gov Identifier: NCT02723409
Recruitment Status : Recruiting
First Posted : March 30, 2016
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Umbilicoplasty Procedure: Round Procedure Umbilicoplasty Procedure: Scarless" round procedure Procedure: "Inverted U" Procedure Procedure: "Inverted V"Procedure Procedure: "Y deepithelialized" Procedure Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 175 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Umbilicoplasty: A Randomized Controlled Trial of Techniques for Umbilical Reconstruction Following Abdominoplasty and Abdominally-based Free Tissue Transfer
Study Start Date : January 2016
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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 ]
  2. Assessment of inter-rater reliability among physicians in the assessment of the aesthetic outcomes of umbilical reconstruction. [ Time Frame: 12 Weeks ]
  3. 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 ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02723409


Contacts
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Contact: Tiffany Drummond drummt02@nyumc.org
Contact: Mihye Choi choim01@nyumc.org

Locations
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United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Tiffany Drummond       drummt02@nyumc.org   
Contact: Mihye Choi       choim01@nyumc.org   
Principal Investigator: Vishal Thanik, MD         
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Vishal` Thanik, MD New York University Medical School

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02723409     History of Changes
Other Study ID Numbers: 15-00480
First Posted: March 30, 2016    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No