Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2016-01-31
2023-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Round Procedure
umbilicoplasty technique
Round Procedure Umbilicoplasty
Umbilicoplasty surgery (belly button reshaping) is performed using the "Round Procedure"
"Scarless" round procedure
umbilicoplasty technique
Scarless" round procedure
Umbilicoplasty surgery (belly button reshaping) is performed using the "Scarless" round procedure
"Inverted U" procedure
umbilicoplasty technique
"Inverted U" Procedure
Umbilicoplasty surgery (belly button reshaping) is performed using the "Inverted U" Procedure
"Inverted V" procedure
umbilicoplasty technique
"Inverted V"Procedure
Umbilicoplasty surgery (belly button reshaping) is performed using the "Inverted V" Procedure
Y deepithelialized" procedure
umbilicoplasty technique
"Y deepithelialized" Procedure
Umbilicoplasty surgery (belly button reshaping) is performed using the "Y deepithelialized" procedure
Interventions
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Round Procedure Umbilicoplasty
Umbilicoplasty surgery (belly button reshaping) is performed using the "Round Procedure"
Scarless" round procedure
Umbilicoplasty surgery (belly button reshaping) is performed using the "Scarless" round procedure
"Inverted U" Procedure
Umbilicoplasty surgery (belly button reshaping) is performed using the "Inverted U" Procedure
"Inverted V"Procedure
Umbilicoplasty surgery (belly button reshaping) is performed using the "Inverted V" Procedure
"Y deepithelialized" Procedure
Umbilicoplasty surgery (belly button reshaping) is performed using the "Y deepithelialized" procedure
Eligibility Criteria
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Inclusion Criteria
* Female patients undergoing abdominoplasty or abdominally-based free tissue transfer (TRAM/DIEP flaps)
Exclusion Criteria
* History of keloid formation
* Active smokers
* Body Mass Index (BMI) over 40
18 Years
65 Years
FEMALE
No
Sponsors
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NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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VIshal Thanik, MD
Role: PRINCIPAL_INVESTIGATOR
New York University Medical School
Locations
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New York University School of Medicine
New York, New York, United States
Countries
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Other Identifiers
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15-00480
Identifier Type: -
Identifier Source: org_study_id
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