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

Phase 1

Completed

• Conditions: Seroma
• Interventions: Procedure: quilting suture

• Registration Number: NCT01358786
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2009-04
• Status Verified: 2009-06
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Study First Submitted: 2011-05-16
• Study First Submitted QC: 2011-05-20
• Study First Posted: 2011-05-24
• Last Update Submitted: 2011-05-25
• Last Update Posted: 2011-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 48

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
no quilting sutures but drains	quilting suture	-
quilting sutures and drains	quilting suture	-
quilting sutures but no drains	quilting suture	-

Primary Outcome Measures

Name	Time	Method
Reducing seroma in donor site of the TRAM flap	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.