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Completed

NCT Number: NCT02076724

Reinforcement of the Abdominal Wall 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.

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Key information

Conditions

Abdominal Donor-site

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Plastic and Reconstructive Surgery, Aarhus University Hospital

Aarhus C, Aarhus, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biological mesh

Device

Other names: Strattice Reconstructive Tissue Matrix Firm, LifeCell Corp.

Synthetic Mesh

Device

Other names: Prolene mesh, Ethicon

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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.

  4. 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)

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Collaborators

  • LifeCell
  • Novo Nordisk A/S
  • University of Aarhus

Registry information

Official study title

Reinforcement of the Abdominal Wall With Acellular Dermal Matrix (Strattice™) After Breast Reconstruction With the Pedicled TRAM-flap

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Mar 4, 2014
Registry last updated
Jan 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.