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

Seroma at the Donor Site of the TRAM Flap, With or Without Quilting Suture.

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.

Study Overview

• Status: Completed
• Conditions: Seroma
• Intervention / Treatment: Procedure: quilting suture

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
• Enrollment (Actual): 48
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: no quilting sutures but drains	Procedure: quilting suture; quilting sutures and drains; quilting sutures but no drains; Other Names: points
EXPERIMENTAL: quilting sutures and drains	Procedure: quilting suture; quilting sutures and drains; quilting sutures but no drains; Other Names: points
EXPERIMENTAL: quilting sutures but no drains	Procedure: quilting suture; quilting sutures and drains; quilting sutures but no drains; Other Names: points

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reducing seroma in donor site of the TRAM flap	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.	15 days

Collaborators and Investigators

• Sponsor: 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.

Publications and helpful links

General 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.
• 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.

Helpful Links

• Federal University of Saint Paul

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (ACTUAL): October 1, 2010
• Study Completion (ACTUAL): October 1, 2010

Study Registration Dates

• First Submitted: May 16, 2011
• First Submitted That Met QC Criteria: May 20, 2011
• First Posted (ESTIMATE): May 24, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): May 26, 2011
• Last Update Submitted That Met QC Criteria: May 25, 2011
• Last Verified: June 1, 2009

More Information

Terms related to this study

• Keywords: Surgery; seroma; Procedure; Quilting suture
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Seroma
• Other Study ID Numbers: CEP 1995 08; CEP 1995/08 (OTHER: Comisão de Ética Médica do Hospital São Paulo)