Clincosm LogoSign in Get a demo

Trial of Techniques for Umbilical Reconstruction

Sponsor
NYU Langone Health (Other)
Overall Status
Recruiting
CT.gov ID
NCT02723409
Collaborator
(none)
175
Enrollment
1
Location
5
Arms
84
Anticipated Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

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
  • Procedure: Round Procedure Umbilicoplasty
  • Procedure: Scarless" round procedure
  • Procedure: "Inverted U" Procedure
  • Procedure: "Inverted V"Procedure
  • Procedure: "Y deepithelialized" Procedure
 N/A

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

Study Type:
Interventional
Anticipated 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 :
Jan 1, 2016
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

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

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 [Baseline, 12 Weeks]

  2. Assessment of inter-rater reliability among physicians in the assessment of the aesthetic outcomes of umbilical reconstruction. [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). [12 Weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 New York University School of Medicine New York New York United States 10016

Sponsors and Collaborators

  • NYU Langone Health

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
NYU Langone Health
ClinicalTrials.gov Identifier:
NCT02723409
Other Study ID Numbers:
  • 15-00480
First Posted:
Mar 30, 2016
Last Update Posted:
Jan 21, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jan 21, 2022