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

February 26, 2014
March 13, 2014
March 2014
October 2017   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT02076724 on ClinicalTrials.gov Archive Site
  • 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)

Same as current
Not Provided
Not Provided
 
Reinforcement of the Abdominal Wall After Breast Reconstruction With the Pedicled TRAM-flap
Reinforcement of the Abdominal Wall With Acellular Dermal Matrix (Strattice™) After Breast Reconstruction With the Pedicled TRAM-flap

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Abdominal Donor-site
  • Device: Biological mesh
    Other Name: Strattice Reconstructive Tissue Matrix Firm, LifeCell Corp.
  • Device: Synthetic mesh
    Other Name: Prolene mesh, Ethicon
  • 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.
    Intervention: Device: Biological mesh
  • 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.
    Intervention: Device: Synthetic mesh
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
October 2017
October 2017   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact: Mette Eline Brunbjerg, MD +45 78466880 mebrun@rm.dk
Contact: Tine E. Damsgaard, MD, PhD +45 78466880 tinedams@rm.dk
Denmark
 
NCT02076724
VEK 1-10-72-10-13
No
Mette Eline Brunbjerg, MD, Aarhus University Hospital
Aarhus University Hospital
  • LifeCell
  • Novo Nordisk A/S
  • University of Aarhus
Principal Investigator: Mette Eline Brunbjerg, MD Aarhus University Hospital and Aarhus University
Aarhus University Hospital
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP