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

NCT02076724 | Completed

• 1 other identifier: VEK 1-10-72-10-13
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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

Keywords

Abdominal donor-site; Breast reconstruction; Synthetic mesh; Biological mesh

Outcome Measures

Primary Outcomes (1)

• Abdominal wall function change

  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.

  Change from before surgery to 12 and 24 months after surgery

Secondary Outcomes (4)

• Abdominal donor site morbidity

  24 months

• Aesthetics at the abdominal wall

  24 months

• Costs

  24 months

• Postoperative complications

  Acute <1 month, ≥ 1 month-24 months

Study Arms (2)

Biological mesh (Strattice Firm)

EXPERIMENTAL

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

Device: Biological mesh

Synthetic mesh (Prolene)

EXPERIMENTAL

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

Device: Synthetic mesh

Interventions

Biological mesh DEVICE

Also known as: Strattice Reconstructive Tissue Matrix Firm, LifeCell Corp.

Biological mesh (Strattice Firm)

Synthetic mesh DEVICE

Also known as: Prolene mesh, Ethicon

Synthetic mesh (Prolene)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Current smokers
• Not eligible patients, assessed by surgeon
• High level of co-morbidity, assessed by surgeon or anesthesiologist

Sponsors & Collaborators

• Aarhus University Hospital: lead
• LifeCell: collaborator
• Novo Nordisk A/S: collaborator
• University of Aarhus: collaborator

Study Sites (1)

Department of Plastic and Reconstructive Surgery, Aarhus University Hospital

Aarhus C, Aarhus, 8000, Denmark

Location

Study Officials

• Mette Eline Brunbjerg, MD

  Aarhus University Hospital and Aarhus University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 26, 2014
• First Posted: March 4, 2014
• Study Start: March 1, 2014
• Primary Completion: January 1, 2019
• Study Completion: March 1, 2019
• Last Updated: January 9, 2020

Record last verified: 2020-01

Locations

DK (1)