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

Seroma Clinical Trial

— STRAMQUSG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01358786
• Other study ID #: CEP 1995 08
• Secondary ID: CEP 1995/08
• Status: Completed
• Phase: Phase 1
• First received: May 16, 2011
• Last updated: May 25, 2011
• Start date: April 2009
• Est. completion date: October 2010

Study information

• Verified date: June 2009
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Seroma

Intervention

Procedure:
• quilting suture
quilting sutures and drains quilting sutures but no drains

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

References & Publications (1)

1. Hartrampf CR, Jr, Scheflan M, Black PW. Breast reconstruction with a transverse abdominal island flap. Plast Reconstr Surg. 1982;69:216-225. 2. Andrades P, Prado A, Danilla S, et al. Progressive tension sutures in the prevention of postabdominoplasty seroma: a prospective, randomized, double-blind clinical trial. Plast Reconstr Surg. 2007;120:935-946. 3. Baroudi R, Ferreira CA. Contouring the hip and the abdomen. Clin Plast Surg. 1996;23:551-572. 4. Rossetto LA, Garcia EB, Abla LF, Neto MS, Ferreira LM. Quilting suture in the donor site of the transverse rectus abdominis musculocutaneous flap in breast reconstruction. Ann Plast Surg. 2009;62:240-243. %. Di Martino M, Nahas FX, Barbosa MV, et al. Seroma in lipoabdominoplasty and abdominoplasty: a comparative study using ultrasound. Plast Reconstr Surg. 2010;126:1742-1751.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reducing seroma in donor site of the TRAM flap	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.	15 days	No

External Links

•   Federal University of Saint Paul