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Reinforcement of the Abdominal Wall After Breast Reconstruction With the Pedicled TRAM-flap

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02076724
First Posted: March 4, 2014
Last Update Posted: March 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
LifeCell
Novo Nordisk A/S
University of Aarhus
Information provided by (Responsible Party):
Mette Eline Brunbjerg, MD, Aarhus University Hospital
  Purpose

The purpose of this study is to compare two methods for reinforcement of the abdominal donor-site after breast reconstruction with the pedicled TRAM-flap. Reinforcement of the abdominal donor-site is performed, after randomization, with either a porcine derived biological mesh or a synthetic mesh. The patient and the investigator is blinded.

The aim is to identify the most optimal method for reinforcement of the abdominal donor-site and thereby contribute to fast and complete rehabilitation of women undergoing breast reconstruction with the pedicled TRAM-flap after surgical removal of the breast tissue due to breast cancer, precursors to breast cancer or an increased risk of developing breast cancer and thereby following preventive removal of the breast tissue.

The patients visit the outpatient clinic 4, 12 and 24 months after operation and abdominal wall function, the donor site morbidity, the frequency of postoperative complications, the aesthetic appearance of the reconstructed breast and the abdominal wall and costs are evaluated.


Condition Intervention
Abdominal Donor-site Device: Biological mesh Device: Synthetic mesh

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Reinforcement of the Abdominal Wall With Acellular Dermal Matrix (Strattice™) After Breast Reconstruction With the Pedicled TRAM-flap

Resource links provided by NLM:


Further study details as provided by Mette Eline Brunbjerg, MD, Aarhus University Hospital:

Primary Outcome Measures:
  • Abdominal wall function change [ Time Frame: Change from before surgery to 12 and 24 months after surgery ]
    Strength of abdominal wall is assessed by a standardized physical examination developed in collaboration with physiotherapists. A dynamometer is used to get an exact value of muscle strength.


Secondary Outcome Measures:
  • Abdominal donor site morbidity [ Time Frame: 24 months ]

    Bulge

    • Definition: visible abdominal contour abnormality, without the presence of a fascial defect, with or without the need for surgical correction.
    • Assessed after 3-4, 12 and 24 months by clinical examination and after 12 and 24 months by CT scanning including the Valsalva maneuver

    Hernia

    • Definition: abdominal wall bulge with the presence of a palpable fascial defect and/or a fascial defect found during an additional correcting surgical procedure or by CT scanning.
    • Assessed after 3-4, 12 and 24 months by clinical examination and after 12 and 24 months by CT scanning including the Valsalva maneuver

    Abdominal donor site correction procedure (within 24 months)

    Pain/ discomfort

    • Assessed after 3-4, 12 and 24 months by
    • DoloTest®
    • Study specific questionnaire regarding postoperative assessment of abdominal pain/ discomfort including effect on daily life activities and ability to perform sport

  • Aesthetics at the abdominal wall [ Time Frame: 24 months ]

    Study specific questionnaire regarding postoperative assessment of the outcome including:

    • Overall satisfaction with the appearance of the abdominal donor site
    • Satisfaction regarding placement and the appearance of the umbilicus

    Investigators assessment of the abdominal donor site including:

    • Visual bulging of the lower abdomen
    • Placement and appearance of the umbilicus
    • Appearance of the scar

  • Costs [ Time Frame: 24 months ]
    National health insurance rate Cost of Strattice (LifeCell), Prolene mesh (Ethicon) Operation time Hospitalization Time to return to work / Duration of sick leave Post-reconstruction procedures to address complications at the abdominal donor site.

  • Postoperative complications [ Time Frame: Acute <1 month, ≥ 1 month-24 months ]

    Hematoma requiring surgical intervention. Cellulitis/ wound infection not requiring surgical intervention but treatment with antibiotics.

    Infection requiring surgical intervention. Seroma requiring intervention Donor site necrosis (present necrosis - excluding epidermolysis, in the umbilical area or in the remaining abdominal skin and subcutaneous tissue requiring surgical intervention)



Enrollment: 30
Study Start Date: March 2014
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Biological mesh (Strattice Firm)
Strattice Firm is inserted using inlay technique as reinforcement of the abdominal wall where the anterior rectus fascia has been excised.
Device: Biological mesh
Other Name: Strattice Reconstructive Tissue Matrix Firm, LifeCell Corp.
Experimental: Synthetic mesh (Prolene)
Prolene mesh is inserted using inlay technique as reinforcement of the abdominal wall where the anterior rectus fascia has been excised.
Device: Synthetic mesh
Other Name: Prolene mesh, Ethicon

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Immediate or delayed breast reconstruction using the pedicled TRAM-flap
  • Older than 18 years of age
  • Understand enough Danish to comprehend the given information and to complete the study questionnaire
  • Verbal and written informed consent

Exclusion Criteria:

  • Current smokers
  • Not eligible patients, assessed by surgeon
  • High level of co-morbidity, assessed by surgeon or anesthesiologist
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02076724


Locations
Denmark
Department of Plastic and Reconstructive Surgery, Aarhus University Hospital
Aarhus C., Aarhus, Denmark, 8000
Sponsors and Collaborators
Aarhus University Hospital
LifeCell
Novo Nordisk A/S
University of Aarhus
Investigators
Principal Investigator: Mette Eline Brunbjerg, MD Aarhus University Hospital and Aarhus University
  More Information

Responsible Party: Mette Eline Brunbjerg, MD, MD, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT02076724     History of Changes
Other Study ID Numbers: VEK 1-10-72-10-13
First Submitted: February 26, 2014
First Posted: March 4, 2014
Last Update Posted: March 20, 2017
Last Verified: March 2017

Keywords provided by Mette Eline Brunbjerg, MD, Aarhus University Hospital:
Abdominal donor-site
Breast reconstruction
Synthetic mesh
Biological mesh