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OpenTrials
Completed

NCT Number: NCT02723409

Trial of Techniques for Umbilical Reconstruction

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.

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Key information

Conditions

Umbilicoplasty

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

New York, 10016, United States

About this study

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:

  • Round procedure
  • "Scarless" round procedure
  • "Inverted u" procedure
  • "Inverted v" procedure, and
  • "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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Round Procedure Umbilicoplasty

Procedure

Umbilicoplasty surgery (belly button reshaping) is performed using the "Round Procedure"

Scarless" round procedure

Procedure

Umbilicoplasty surgery (belly button reshaping) is performed using the "Scarless" round procedure

"Inverted U" Procedure

Procedure

Umbilicoplasty surgery (belly button reshaping) is performed using the "Inverted U" Procedure

"Inverted V"Procedure

Procedure

Umbilicoplasty surgery (belly button reshaping) is performed using the "Inverted V" Procedure

"Y deepithelialized" Procedure

Procedure

Umbilicoplasty surgery (belly button reshaping) is performed using the "Y deepithelialized" procedure

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Mar 30, 2016
Registry last updated
Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.