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

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.

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Key information

Conditions

Seroma Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

quilting suture

Procedure

quilting sutures and drains
quilting sutures but no drains

Other names: points

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

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

Acronym: STRAMQUSG

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: May 24, 2011
Registry last updated: May 26, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed