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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
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Seroma focused on measuring Quilting suture, seroma, Procedure, Surgery

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept 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.

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

    First Posted
    May 16, 2011
    Last Updated
    May 25, 2011
    Sponsor
    Federal University of São Paulo
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    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

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

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