Seroma at the Donor Site of the TRAM Flap, With or Without Quilting Suture: A Comparative Study Using Ultrasound (STRAMQUSG)

This study has been completed.
Sponsor:
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01358786
First received: May 16, 2011
Last updated: May 25, 2011
Last verified: June 2009
  Purpose

Patient undergoing breast reconstruction with lower abdominal flap, benefit when points are used for membership (between the aponeurosis of the abdominal flap and underlying muscles) for closing the donor area, where there is reduced incidence of complications.


Condition Intervention Phase
Seroma
Procedure: quilting suture
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Seroma at the Donor Site of the TRAM Flap, With or Without Quilting Suture.

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Reducing seroma in donor site of the TRAM flap [ Time Frame: 15 days ] [ Designated as safety issue: No ]
    Seroma formation was identified clinically and confirmed by ultrasound examination. Clinical examination consisted of evaluation of early symptoms (bulging and distension of the skin, signs of fluid accumulation), palpation, and percussion. Ultrasound examination was performed on postoperative days 7 and 14 to detect the presence of seroma at the TRAM flap donor site. The patients were placed in the supine position during the examination. Upon detection of seroma, ultrasound-guided puncture was performed, and the number of punctures and volume of seroma aspirated were recorded.


Enrollment: 48
Study Start Date: April 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: no quilting sutures but drains Procedure: quilting suture
  • quilting sutures and drains
  • quilting sutures but no drains
Other Name: points
Experimental: quilting sutures and drains Procedure: quilting suture
  • quilting sutures and drains
  • quilting sutures but no drains
Other Name: points
Experimental: quilting sutures but no drains Procedure: quilting suture
  • quilting sutures and drains
  • quilting sutures but no drains
Other Name: points

Detailed Description:

This study evaluated seroma formation at the donor site of the TRAM patients who underwent breast reconstruction. Forty-eight breast reconstructions were performed using the bipedicled TRAM flap. The patients were randomly allocated into three groups of 16 participants each: DN group, use of suction drains but no quilting sutures between the remaining abdominal flap and musculoaponeurotic layer of the anterior abdominal wall; QS+DN group, use of quilting sutures and suction drains; and QS group, use of quilting sutures but no suction drains. In order to determine seroma formation, ultrasound examinations were performed on postoperative days 7 and 14 in 5 regions of the abdominal wall: epigastric, umbilical, hypogastric, right iliac, and left iliac regions.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • were age between 20 and 65 years
  • body mass index (BMI) ≤ 30 kg/m2
  • non-smokers.

Exclusion criteria:

  • no skin excess in the infraumbilical region
  • previous abdominoplasty
  • uncontrolled systemic disease
  • such as diabetes mellitus and arterial hypertension
  • collagen diseases
  • psychiatric disorders
  • large weight loss
  • and/or postoperative abdominal scars that could hinder flap vascularization.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01358786

Sponsors and Collaborators
Federal University of São Paulo
Investigators
Study Director: luis Rossetto, MD Graduate Program in Plastic Surgery, School of Medicine, Universidade Federal de São PaConception and design of the study, drafting the article, revising it critically for important intellectual content, and final approval of the version to be submitted.
  More Information

Additional Information:
No publications provided

Responsible Party: Graduate Program in Plastic Surgery, School of Medicine, Luis Antonio Rossetto
ClinicalTrials.gov Identifier: NCT01358786     History of Changes
Other Study ID Numbers: CEP 1995 08, CEP 1995/08
Study First Received: May 16, 2011
Last Updated: May 25, 2011
Health Authority: Brazil: Ministry of Health

Keywords provided by Federal University of São Paulo:
Quilting suture
seroma
Procedure
Surgery

Additional relevant MeSH terms:
Seroma
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on October 21, 2014