A Comparison Between Biological (Veritas®) vs Non Biological Mesh (TIGR®) in Immediate Breast Reconstruction

Vastra Gotaland Region

Status: Completed

Conditions: Breast Cancer

Treatments: Device: Veritas®; Device: TIGR®

Study type: Interventional

Funder types: Other

Identifiers

NCT02985073

189-16

Details and patient eligibility

About

This study compares the outcome using a biological mesh (Veritas®) compared to a non biological mesh (TIGR®) in immediate breast reconstruction.

Full description

The scientific evidence using different types of mesh in breast reconstruction is low at present with very few randomized controlled studies.

This study aims to compare a biological mesh (Veritas®) compared to a non biological mesh (TIGR®) in patients with hereditary increased risk of developing breast cancer operated with bilateral immediate breast reconstruction regarding implant loss rate,infections,total complication rate,aesthetic outcome, HQOL (health related quality of Life) and economics.

The patients will be enrolled to the study and sign an informed consent. At the operating theater the patient is randomized either to be reconstructed with Veritas® in one breast and TIGR® in the other breast..

The patients will be followed up according to a specified schedule until one year postoperatively as above.

Enrollment: 24 patients

Sex: Female

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with a confirmed breast cancer gene mutation or a calculated increased risk > 20% of developing a breast cancer during her lifetime.

Exclusion criteria

• All patients that don't fulfill criteria above
• Previous breast surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 2 patient groups

Veritas® mesh

Experimental group

Description:

Use of Veritas mesh in conjunction with immediate breast reconstruction on one side

Treatment:

Device: Veritas®

TIGR® mesh

Experimental group

Description:

Use of TIGR® mesh in conjunction with immediate breast reconstruction on one side

Treatment:

Device: TIGR®