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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Aarhus University Hospital
Sponsor:
Collaborators:
LifeCell
Novo Nordisk A/S
University of Aarhus
Information provided by (Responsible Party):
Mette Eline Brunbjerg, MD, Aarhus University Hospital
ClinicalTrials.gov Identifier:
NCT02076724
First received: February 26, 2014
Last updated: March 13, 2014
Last verified: March 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Aarhus University Hospital:

Primary Outcome Measures:
  • Abdominal wall function change [ Time Frame: Change from before surgery to 12 and 24 months after surgery ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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)



Estimated Enrollment: 40
Study Start Date: March 2014
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (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

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02076724

Contacts
Contact: Mette Eline Brunbjerg, MD +45 78466880 mebrun@rm.dk
Contact: Tine E. Damsgaard, MD, PhD +45 78466880 tinedams@rm.dk

Locations
Denmark
Department of Plastic and Reconstructive Surgery, Aarhus University Hospital Recruiting
Aarhus C., Aarhus, Denmark, 8000
Contact: Mette Eline Brunbjerg, MD       mebrun@rm.dk   
Sub-Investigator: Tine E. Damsgaard, MD, PhD         
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

No publications provided

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
Study First Received: February 26, 2014
Last Updated: March 13, 2014
Health Authority: Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

Keywords provided by Aarhus University Hospital:
Abdominal donor-site
Breast reconstruction
Synthetic mesh
Biological mesh

ClinicalTrials.gov processed this record on October 19, 2014