NCT02985073

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

The Gothenburg TIGR/Veritas® Study - A Comparison Between Biological (Veritas®) vs Non Biological Mesh (TIGR®) in Immediate Breast Reconstruction

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Vastra Gotaland Region · Other Government
• Sex: Female
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DEVICE	Veritas®	Biologic mesh
DEVICE	TIGR®	Non biologic mesh

Timeline

• Start date: 2016-11-01
• Primary completion: 2020-01-01
• Completion: 2022-09-01
• First posted: 2016-12-07
• Last updated: 2022-10-17

Locations

1 site across 1 country: Sweden