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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 : January 21, 2022
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Study Description
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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.

Study Design
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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
Actual Study Start Date : January 2016
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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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 ]

Eligibility Criteria
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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
Contacts and Locations
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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: Thomas Calahan 929-455-5826 thomas.calahan@nyulangone.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: Thomas Calahan    929-455-5826    thomas.calahan@nyulangone.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
More Information
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02723409    
Other Study ID Numbers: 15-00480
First Posted: March 30, 2016    Key Record Dates
Last Update Posted: January 21, 2022
Last Verified: January 2022

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