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

NCT01942707 | Unknown Results

• 1 other identifier: INFORZATO55
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Seroma

Keywords

Abdominoplasty,Seroma,Bariatric surgery

Outcome Measures

Primary Outcomes (1)

• 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of drainage will be done at the same time (8:00 am) and by the same nurse everyday in all patients until the drain is withdrawn. The drain will be withdrawn when the drained volume is less than 30 ml in 24 hours.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 Outcomes (2)

• Number of Days Required for Drain Withdrawal.

  Number of days required for drain withdrawal (drained volume less than 30 ml in 24 hours) and no later than 10 days

• Volume of Seroma Assessed by Ultrasound of the Abdominal Wall.

  Done after 20 days of surgery

Study Arms (2)

Abdominoplasty without Scarpa´s Facia

ACTIVE COMPARATOR

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

Procedure: Abdominoplasty without Scarpa´s Facia

abdominoplasty with Scarpa's Fascia

EXPERIMENTAL

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

Procedure: abdominoplasty with Scarpa's Fascia

Interventions

abdominoplasty with Scarpa's Fascia PROCEDURE

During surgical detachment of the abdominal flap the Scarpa´s fascia is preserved.

abdominoplasty with Scarpa's Fascia

Abdominoplasty without Scarpa´s Facia PROCEDURE

During surgical detachment of the abdominal flap the Scarpa´s fascia is removed.

Abdominoplasty without Scarpa´s Facia

Eligibility Criteria

• Age: 24 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• BMI between 22 and 30 Kg/m2
• Female post-bariatric patient

You may not qualify if:

• neoplasms
• Diabetes
• lymphatic system diseases
• abdominal scars except C section and bariatric surgery scars
• mental disorders

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Federal University of São Paulo

São Paulo, São Paulo, 04024002, Brazil

Location

Related Publications (29)

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MeSH Terms

Conditions

Seroma

Interventions

Abdominoplasty

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cosmetic Techniques; Therapeutics; Plastic Surgery Procedures; Surgical Procedures, Operative

Results Point of Contact

• Title: Dr. Heraldo Carlos Borges Inforzato
• Organization: Universidade Federal de São Paulo

heraldo@litoral.com.br

55-13-997112644

Study Officials

• Lydia M Ferreira, MD, Phd

  Federal University of São Paulo

  STUDY CHAIR

• Juan C Montano-Pedroso, PhD

  Federal University of São Paulo

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patient will not know if the Scarpa´s fascia has been removed or preserved.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M D - Professor

Study Record Dates

• First Submitted: September 11, 2013
• First Posted: September 16, 2013
• Study Start: March 1, 2013
• Primary Completion: April 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 29, 2018
• Results First Posted: August 3, 2017

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)