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

Aarhus University Hospital

Status: Completed

Conditions: Abdominal Donor-site

Treatments: Device: Biological mesh; Device: Synthetic mesh

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02076724

VEK 1-10-72-10-13

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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29 participants in 2 patient groups

Biological mesh (Strattice Firm)

Experimental group

Description:

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

Treatment:

Device: Biological mesh

Synthetic mesh (Prolene)

Experimental group

Description:

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

Treatment:

Device: Synthetic mesh