Umbilicoplasty
Conditions
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.
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.
Interventions
PROCEDURERound Procedure Umbilicoplasty
Umbilicoplasty surgery (belly button reshaping) is performed using the Round Procedure
PROCEDUREScarless round procedure
Umbilicoplasty surgery (belly button reshaping) is performed using the Scarless round procedure
PROCEDUREInverted U Procedure
Umbilicoplasty surgery (belly button reshaping) is performed using the Inverted U Procedure
PROCEDUREInverted VProcedure
Umbilicoplasty surgery (belly button reshaping) is performed using the Inverted V Procedure
PROCEDUREY deepithelialized Procedure
Umbilicoplasty surgery (belly button reshaping) is performed using the Y deepithelialized procedure
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | 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 |
Countries
United States
Outcome results
None listed