Breast Cancer
Conditions
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.
Interventions
DEVICEVeritas®
Biologic mesh
DEVICETIGR®
Non biologic mesh
Sponsors
Vastra Gotaland Region
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total complication rate | 12 months | Total complication rate within one year from surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total infection rate | 30 days | Total infection rate within 30 days from surgery |
| Total implant loss rate | 12 months | Total implant loss rate within one year 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 |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cost evaluation | 12 months | Cost evaluation at one year followup will be evaluated in cooperation with hospital Economists,calculating the total post per patient with or without a mesh. |
Countries
Sweden
Outcome results
None listed