Trial of Techniques for Umbilical Reconstruction

Not Applicable

Completed

• Conditions: Umbilicoplasty
• Interventions: Procedure: Round Procedure Umbilicoplasty; Procedure: Scarless" round procedure; Procedure: "Inverted V"Procedure; Procedure: "Y deepithelialized" Procedure; Procedure: "Inverted U" Procedure

• Registration Number: NCT02723409
• Lead Sponsor: NYU Langone Health

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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-03-08
• Study First Submitted QC: 2016-03-23
• Study First Posted: 2016-03-30
• Primary Completion: 2023-08
• Study Completion: 2023-08
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-08
• Last Update Posted: 2023-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

• Signed Informed Consent Form
• Female patients undergoing abdominoplasty or abdominally-based free tissue transfer (TRAM/DIEP flaps)

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Exclusion Criteria

• Patients with prior history of umbilicoplasty
• History of keloid formation
• Active smokers
• Body Mass Index (BMI) over 40

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Round Procedure	Round Procedure Umbilicoplasty	umbilicoplasty technique
"Scarless" round procedure	Scarless" round procedure	umbilicoplasty technique
"Inverted V" procedure	"Inverted V"Procedure	umbilicoplasty technique
Y deepithelialized" procedure	"Y deepithelialized" Procedure	umbilicoplasty technique
"Inverted U" procedure	"Inverted U" Procedure	umbilicoplasty technique

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States