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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2010-10-31

Brief Summary

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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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Appendix

COMPLETED

Detailed Description

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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

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Seroma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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no quilting sutures but drains

Group Type NO_INTERVENTION

quilting suture

Intervention Type PROCEDURE

* quilting sutures and drains
* quilting sutures but no drains

quilting sutures and drains

Group Type EXPERIMENTAL

quilting suture

Intervention Type PROCEDURE

* quilting sutures and drains
* quilting sutures but no drains

quilting sutures but no drains

Group Type EXPERIMENTAL

quilting suture

Intervention Type PROCEDURE

* quilting sutures and drains
* quilting sutures but no drains

Interventions

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quilting suture

* quilting sutures and drains
* quilting sutures but no drains

Intervention Type PROCEDURE

Other Intervention Names

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points

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Luis Antonio Rossetto

Principal Investigators

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luis Rossetto, MD

Role: STUDY_DIRECTOR

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.