Umbilicoplasty: A Randomized Controlled Trial of Techniques for Umbilical Reconstruction Following Abdominoplasty and Abdominally-based Free Tissue Transfer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Umbilicoplasty
- Sponsor
- NYU Langone Health
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Change in measurement of patient assessment post-operative and pre-operative, using a VAS survey results with a positive result indicating a favorable outcome
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
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
Assessment of inter-rater reliability among physicians in the assessment of the aesthetic outcomes of umbilical reconstruction.
Time Frame: 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).
Time Frame: 12 Weeks