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

Seroma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01942707
• Other study ID #: INFORZATO55
• Status: Active, not recruiting
• Phase: N/A
• First received: September 11, 2013
• Last updated: March 1, 2018
• Start date: March 2013
• Est. completion date: December 2018

Study information

• Verified date: March 2018
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 46
• Est. completion date: December 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 24 Years to 55 Years

Eligibility

Inclusion Criteria:

• BMI between 22 and 30 Kg/m2

• Female post-bariatric patient

Exclusion Criteria:

• neoplasms

• Diabetes

• lymphatic system diseases

• abdominal scars except C section and bariatric surgery scars

• mental disorders

Related Conditions & MeSH terms

• Seroma

Intervention

Procedure:
• abdominoplasty with Scarpa`s Fascia
During surgical detachment of the abdominal flap the Scarpa´s fascia is preserved.
• Abdominoplasty without Scarpa´s Facia
During surgical detachment of the abdominal flap the Scarpa´s fascia is removed.

Locations

Country	Name	City	State
Brazil	Federal University of São Paulo	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (29)

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* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Volume of Drainage in ml.	We will measure the total volume of drainage, in ml, obtained by the drains in the abdominal region. The measure of drainage will be done at the same time (8:00 am) and by the same nurse everyday in all patients until the drain is withdrawn. The drain will be withdrawn when the drained volume is less than 30 ml in 24 hours. Total volume of drainage will be calculated as the sum of the volumes obtained daily.	number of days required for drain withdrawal (drained volume less than 30 ml in 24 hours) and no later than 10 days
Secondary	Number of Days Required for Drain Withdrawal.	Number of days required for drain withdrawal. The measure of drainage will be done at the same time (8:00 am) and by the same nurse everyday in all patients until the drain is withdrawn. The drain will be withdrawn when the drained volume is less than 30 ml in 24 hours.	Number of days required for drain withdrawal (drained volume less than 30 ml in 24 hours) and no later than 10 days
Secondary	Volume of Seroma Assessed by Ultrasound of the Abdominal Wall.	An ultrasound of the abdominal wall will be realized to check the volume of any residual seroma.	Done after 20 days of surgery