Clinical trial NCT01358786: Seroma at the Donor Site of the TRAM Flap, With or Without Quilting Suture: A Comparative Study Using Ultrasound
Official title: Seroma at the Donor Site of the TRAM Flap, With or Without Quilting Suture.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Seroma
Keywords: Quilting suture
seroma
Procedure
Surgery
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2011-05-24
Enrollment: 48
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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 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.

Primary outcomes:
measure: Reducing seroma in donor site of the TRAM flap
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: 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.
name: luis Rossetto, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Rossetto LA, Garcia EB, Abla LE, Ferreira LM. Seroma and quilting suture at the donor site of the TRAM flap in breast reconstruction: a prospective randomized double-blind clinical trial. Ann Plast Surg. 2014 Apr;72(4):391-7. doi: 10.1097/SAP.0b013e3182610b11.