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

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ClinicalTrials.gov Identifier: NCT01358786
Recruitment Status : Completed
First Posted : May 24, 2011
Last Update Posted : May 26, 2011
Sponsor:
Information provided by:
Federal University of São Paulo

Brief Summary:
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 or disease Intervention/treatment Phase
Seroma Procedure: quilting suture Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Seroma at the Donor Site of the TRAM Flap, With or Without Quilting Suture.
Study Start Date : April 2009
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Reducing seroma in donor site of the TRAM flap [ Time Frame: 15 days ]
    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.



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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.

Additional Information:
Publications:
1. Hartrampf CR, Jr, Scheflan M, Black PW. Breast reconstruction with a transverse abdominal island flap. Plast Reconstr Surg. 1982;69:216-225. 2. Andrades P, Prado A, Danilla S, et al. Progressive tension sutures in the prevention of postabdominoplasty seroma: a prospective, randomized, double-blind clinical trial. Plast Reconstr Surg. 2007;120:935-946. 3. Baroudi R, Ferreira CA. Contouring the hip and the abdomen. Clin Plast Surg. 1996;23:551-572. 4. Rossetto LA, Garcia EB, Abla LF, Neto MS, Ferreira LM. Quilting suture in the donor site of the transverse rectus abdominis musculocutaneous flap in breast reconstruction. Ann Plast Surg. 2009;62:240-243. %. Di Martino M, Nahas FX, Barbosa MV, et al. Seroma in lipoabdominoplasty and abdominoplasty: a comparative study using ultrasound. Plast Reconstr Surg. 2010;126:1742-1751.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 ( Other Identifier: Comisão de Ética Médica do Hospital São Paulo )
First Posted: May 24, 2011    Key Record Dates
Last Update Posted: May 26, 2011
Last Verified: June 2009

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

Additional relevant MeSH terms:
Seroma
Inflammation
Pathologic Processes