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

NCT02076724 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2020-01-09

No results posted yet for this study

Summary

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.

Conditions

  • Abdominal Donor-site

Interventions

DEVICE

Biological mesh

DEVICE

Synthetic mesh

Sponsors & Collaborators

  • LifeCell

    collaborator INDUSTRY

  • Novo Nordisk A/S

    collaborator INDUSTRY

  • University of Aarhus

    collaborator OTHER

  • Aarhus University Hospital

    lead OTHER

Principal Investigators

  • Mette Eline Brunbjerg, MD · Aarhus University Hospital and Aarhus University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2019-01-31
Completion
2019-03-31

Countries

  • Denmark

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02076724 on ClinicalTrials.gov