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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Device: Veritas®; Device: TIGR®

• Registration Number: NCT02985073
• Lead Sponsor: Vastra Gotaland Region

Brief 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.

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2016-11-30
• Study First Submitted QC: 2016-12-02
• Study First Posted: 2016-12-07
• Primary Completion: 2020-01
• Study Completion: 2022-09
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-13
• Last Update Posted: 2022-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Veritas® mesh	Veritas®	Use of Veritas mesh in conjunction with immediate breast reconstruction on one side
TIGR® mesh	TIGR®	Use of TIGR® mesh in conjunction with immediate breast reconstruction on one side

Primary Outcome Measures

Name	Time	Method
Total complication rate	12 months	Total complication rate within one year from surgery

Secondary Outcome Measures

Name	Time	Method
Total infection rate	30 days	Total infection rate within 30 days from surgery
Aesthetic outcome	12 months	Aesthetic outcome at one year followup will be assessed by analysis of 3-dimensional pre- and post-op pictures in combination with a panel evaluating different aesthetical units of the breast
Total implant loss rate	12 months	Total implant loss rate within one year from surgery
HQOL	12 months	Three validated questionaries will be used to assess HQOL: EQ-5D,HAD30 and BreastQ. The patient fills in these preoperatively and one year postop

Trial Locations

Locations (1)

Dept . of plastic surgery; 🇸🇪 Goteborg, Västra Götaland, Sweden