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

NCT01942707 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2018-03-29

Study results available
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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

Interventions

PROCEDURE

abdominoplasty with Scarpa's Fascia

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

PROCEDURE

Abdominoplasty without Scarpa´s Facia

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

Sponsors & Collaborators

  • Federal University of São Paulo

    lead OTHER

Principal Investigators

  • Lydia M Ferreira, MD, Phd · Federal University of São Paulo

  • Juan C Montano-Pedroso, PhD · Federal University of São Paulo

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
24 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2018-04-30
Completion
2018-12-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01942707 on ClinicalTrials.gov