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

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

Detailed Description
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: Veritas®
* Device: TIGR®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Veritas® mesh<br>Use of Veritas mesh in conjunction with immediate breast reconstruction on one side | Device: Veritas®<br>* Biologic mesh<br>|
| Experimental: TIGR® mesh<br>Use of TIGR® mesh in conjunction with immediate breast reconstruction on one side | Device: TIGR®<br>* Non biologic mesh<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total complication rate | Total complication rate within one year from surgery | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total infection rate | Total infection rate within 30 days from surgery | 30 days | 
| Total implant loss rate | Total implant loss rate within one year from surgery | 12 months | 
| Aesthetic outcome | 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 | 12 months | 
| HQOL | Three validated questionaries will be used to assess HQOL: EQ-5D,HAD30 and BreastQ. The patient fills in these preoperatively and one year postop | 12 months |