Suspended

Study of Scarpa´s Fascia in the Formation of Seroma Post Abdominoplasty After Bariatric Surgery

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What is being tested

abdominoplasty with Scarpa's Fascia

+ Abdominoplasty without Scarpa´s Facia

Procedure
Who is being recruted

Inflammation+1

+ Pathologic Processes

+ Pathological Conditions, Signs and Symptoms

From 24 to 55 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: March 2013
See protocol details

Summary

Principal SponsorFederal University of São Paulo
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2013

Actual date on which the first participant was enrolled.

Morbid obesity has been increasing in Brazil and the world and bariatric surgery is the most effective and long-lasting treatment. This leads to large weight losses leading to large body deformities due to excess skin and subcutaneous tissue. The most common post-bariatric plastic surgery is post-bariatric abdominoplasty which main complication is seroma. PURPOSE: To evaluate the effect of Scarpa fascia preservation in seroma reduction. METHODS: A total of 46 patients were randomly assigned to two groups. One group will have the Fascia Scarpa removed and in the other the Fascia Scarpa will be preserved. The drains will be removed when the volume is less than 30 ml in 24 hours. The primary outcome will be the volume of total drainage obtained in the drains of the abdominal region. Secondary outcomes will be the length of time the drains remain and the presence of seroma assessed by ultrasound on the twentieth postoperative day.

Official TitleStudy of Scarpa´s Fascia in the Formation of Seroma Post Abdominoplasty After Bariatric Surgery
NCT01942707
Principal SponsorFederal University of São Paulo
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

46 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 24 to 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

InflammationPathologic ProcessesPathological Conditions, Signs and SymptomsSeroma

Criteria

2 inclusion criteria required to participate
BMI between 22 and 30 Kg/m2

Female post-bariatric patient

5 exclusion criteria prevent from participating
neoplasms

Diabetes

lymphatic system diseases

abdominal scars except C section and bariatric surgery scars

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Anchor-line abdominoplasty where the Scarpa's Fascia will be preserved.

Group II

Active Comparator
Anchor-line abdominoplasty where the Scarpa's Fascia will be removed.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Federal University of São Paulo

São Paulo, BrazilOpen Federal University of São Paulo in Google Maps
SuspendedOne Study Center