This study compares the outcome using a biological mesh (Veritas®) compared to a non biological mesh (TIGR®) in immediate breast reconstruction.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
24
Dept . of plastic surgery
Gothenburg, Västra Götaland County, Sweden
Total complication rate
Total complication rate within one year from surgery
Time frame: 12 months
Total infection rate
Total infection rate within 30 days from surgery
Time frame: 30 days
Total implant loss rate
Total implant loss rate within one year from surgery
Time frame: 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
Time frame: 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
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.