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

NCT ID: NCT02076724

Last Updated: 2020-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2019-03-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Biological mesh

Intervention Type: DEVICE

Synthetic mesh (Prolene)

Prolene mesh is inserted using inlay technique as reinforcement of the abdominal wall where the anterior rectus fascia has been excised.

Group Type: EXPERIMENTAL

Synthetic mesh

Intervention Type: DEVICE

Interventions

Biological mesh

Intervention Type: DEVICE

Synthetic mesh

Intervention Type: DEVICE

Other Intervention Names

Strattice Reconstructive Tissue Matrix Firm, LifeCell Corp.; Prolene mesh, Ethicon

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

LifeCell

INDUSTRY

Sponsor Role: collaborator

Novo Nordisk A/S

INDUSTRY

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: collaborator

Aarhus University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mette Eline Brunbjerg, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mette Eline Brunbjerg, MD

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital and Aarhus University

Locations

Department of Plastic and Reconstructive Surgery, Aarhus University Hospital

Aarhus C, Aarhus, Denmark

Countries

Denmark

Other Identifiers

VEK 1-10-72-10-13

Identifier Type: -

Identifier Source: org_study_id