Trial of Techniques for Umbilical Reconstruction

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Umbilicoplasty

Intervention / Treatment
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* Procedure: Round Procedure Umbilicoplasty
* Procedure: Scarless round procedure
* Procedure: Inverted U Procedure
* Procedure: Inverted VProcedure
* Procedure: Y deepithelialized Procedure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |  | Baseline, 12 Weeks | 
| Assessment of inter-rater reliability among physicians in the assessment of the aesthetic outcomes of umbilical reconstruction. |  | 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). |  | 12 Weeks |