Seroma at the Donor Site of the TRAM Flap, With or Without Quilting Suture: A Comparative Study Using Ultrasound (STRAMQUSG)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Seroma |
Procedure: quilting suture |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Caregiver, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Seroma at the Donor Site of the TRAM Flap, With or Without Quilting Suture. |
- Reducing seroma in donor site of the TRAM flap [ Time Frame: 15 days ] [ Designated as safety issue: No ]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.
| Enrollment: | 48 |
| Study Start Date: | April 2009 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| No Intervention: no quilting sutures but drains |
Procedure: quilting suture
Other Name: points
|
| Experimental: quilting sutures and drains |
Procedure: quilting suture
Other Name: points
|
| Experimental: quilting sutures but no drains |
Procedure: quilting suture
Other Name: points
|
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.
Eligibility| Ages Eligible for Study: | 20 Years to 65 Years |
| Genders Eligible for Study: | Female |
| Accepts 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.
Contacts and Locations| Study Director: | luis Rossetto, MD | 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. |
More Information
Additional Information:
No publications provided
| Responsible Party: | Graduate Program in Plastic Surgery, School of Medicine, Luis Antonio Rossetto |
| ClinicalTrials.gov Identifier: | NCT01358786 History of Changes |
| Other Study ID Numbers: | CEP 1995 08, CEP 1995/08 |
| Study First Received: | May 16, 2011 |
| Last Updated: | May 25, 2011 |
| Health Authority: | Brazil: Ministry of Health |
Keywords provided by Federal University of São Paulo:
|
Quilting suture seroma Procedure Surgery |
Additional relevant MeSH terms:
|
Seroma Inflammation Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013