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

F

Federal University of São Paulo

Status and phase

Completed
Phase 1

Conditions

Seroma

Treatments

Procedure: quilting suture

Study type

Interventional

Funder types

Other

Identifiers

NCT01358786
CEP 1995/08 (Other Identifier)
CEP 1995 08

Details and patient eligibility

About

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.

Full 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.

Enrollment

48 patients

Sex

Female

Ages

20 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

48 participants in 3 patient groups

no quilting sutures but drains
No Intervention group
Treatment:
Procedure: quilting suture
quilting sutures and drains
Experimental group
Treatment:
Procedure: quilting suture
quilting sutures but no drains
Experimental group
Treatment:
Procedure: quilting suture

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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