Seroma at the Donor Site of the TRAM Flap, With or Without Quilting Suture: A Comparative Study Using Ultrasound (STRAMQUSG)
Primary Purpose
Seroma
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
quilting suture
Sponsored by
About this trial
This is an interventional prevention trial for Seroma focused on measuring Quilting suture, seroma, Procedure, Surgery
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
no quilting sutures but drains
quilting sutures and drains
quilting sutures but no drains
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01358786
First Posted
May 16, 2011
Last Updated
May 25, 2011
Sponsor
Federal University of São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT01358786
Brief Title
Seroma at the Donor Site of the TRAM Flap, With or Without Quilting Suture: A Comparative Study Using Ultrasound
Acronym
STRAMQUSG
Official Title
Seroma at the Donor Site of the TRAM Flap, With or Without Quilting Suture.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Federal University of São Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seroma
Keywords
Quilting suture, seroma, Procedure, Surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
no quilting sutures but drains
Arm Type
No Intervention
Arm Title
quilting sutures and drains
Arm Type
Experimental
Arm Title
quilting sutures but no drains
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
quilting suture
Other Intervention Name(s)
points
Intervention Description
quilting sutures and drains
quilting sutures but no drains
Primary Outcome Measure Information:
Title
Reducing seroma in donor site of the TRAM flap
Description
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.
Time Frame
15 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
luis Rossetto, MD
Organizational Affiliation
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.
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
Citation
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.
Results Reference
background
PubMed Identifier
23407260
Citation
Rossetto LA, Garcia EB, Abla LE, Ferreira LM. Seroma and quilting suture at the donor site of the TRAM flap in breast reconstruction: a prospective randomized double-blind clinical trial. Ann Plast Surg. 2014 Apr;72(4):391-7. doi: 10.1097/SAP.0b013e3182610b11.
Results Reference
derived
Links:
URL
http://www.unifesp.br
Description
Federal University of Saint Paul
Learn more about this trial
Seroma at the Donor Site of the TRAM Flap, With or Without Quilting Suture: A Comparative Study Using Ultrasound
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