Trial of Techniques for Umbilical Reconstruction

NYU Langone Health

Status: Completed

Conditions: Umbilicoplasty

Treatments: Procedure: Round Procedure Umbilicoplasty; Procedure: Scarless" round procedure; Procedure: "Inverted U" Procedure; Procedure: "Y deepithelialized" Procedure; Procedure: "Inverted V"Procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT02723409

15-00480

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 5 patient groups

Round Procedure

Active Comparator group

Description:

umbilicoplasty technique

Treatment:

Procedure: Round Procedure Umbilicoplasty

"Scarless" round procedure

Active Comparator group

Description:

umbilicoplasty technique

Treatment:

Procedure: Scarless" round procedure

"Inverted U" procedure

Active Comparator group

Description:

umbilicoplasty technique

Treatment:

Procedure: "Inverted U" Procedure

"Inverted V" procedure

Active Comparator group

Description:

umbilicoplasty technique

Treatment:

Procedure: "Inverted V"Procedure

Y deepithelialized" procedure

Active Comparator group

Description:

umbilicoplasty technique

Treatment:

Procedure: "Y deepithelialized" Procedure