Clinical Trials Directory

Trials / Unknown

UnknownNCT01942707

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

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
46 (actual)
Sponsor
Federal University of São Paulo · Academic / Other
Sex
Female
Age
24 Years – 55 Years
Healthy volunteers
Not accepted

Summary

46 female postbariatric patients will be submitted to anchor-line abdominoplasty with drains insertion. Patients will be randomized 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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREabdominoplasty with Scarpa's FasciaDuring surgical detachment of the abdominal flap the Scarpa´s fascia is preserved.
PROCEDUREAbdominoplasty without Scarpa´s FaciaDuring surgical detachment of the abdominal flap the Scarpa´s fascia is removed.

Timeline

Start date
2013-03-01
Primary completion
2018-04-01
Completion
2018-12-01
First posted
2013-09-16
Last updated
2018-03-29
Results posted
2017-08-03

Locations

1 site across 1 country: Brazil

Source: ClinicalTrials.gov record NCT01942707. Inclusion in this directory is not an endorsement.