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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
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01358786
Acronym
STRAMQUSG
Enrollment
48
Registered
2011-05-24
Start date
2009-04-30
Completion date
2010-10-31
Last updated
2011-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Seroma

Keywords

Quilting suture, seroma, Procedure, Surgery

Brief 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.

Interventions

PROCEDUREquilting suture

* quilting sutures and drains * quilting sutures but no drains

Sponsors

Federal University of São Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Reducing seroma in donor site of the TRAM flap15 daysSeroma 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026