Clinical Trials Directory

Trials / Completed

CompletedNCT01358786

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

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

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
48 (actual)
Sponsor
Federal University of São Paulo · Academic / Other
Sex
Female
Age
20 Years – 65 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREquilting suture* quilting sutures and drains * quilting sutures but no drains

Timeline

Start date
2009-04-01
Primary completion
2010-10-01
Completion
2010-10-01
First posted
2011-05-24
Last updated
2011-05-26

Source: ClinicalTrials.gov record NCT01358786. Inclusion in this directory is not an endorsement.