Breast Cancer, Hereditary Breast and Ovarian Cancer Syndrome
Conditions
Keywords
breast, reconstruction, mesh, acellular dermal matrix
Brief summary
Randomized controlled trial to look at early complications, cosmetic outcome, patient satisfaction and thickness of the tissue overlying the implant at the lower pole in immediate implant based breast reconstruction after Skin or Nipple Sparing Mastectomy with either a mesh (TiLOOP Bra) or an ADM (Protexa). Multicenter austrian trial with four breast cancer centers, 50 patients randomized 1:1 in the TiLoop or Protexa group.
Interventions
DEVICETiLoop Bra
DEVICEProtexa
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* breast cancer patients with indication for skin or nipple sparing mastectomy * BRCA1/2 mutation carriers with indication for skin or nipple sparing mastectomy
Exclusion criteria
* prior local radiotherapy * inflammatory breast cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| complications | up to two weeks after surgery | hematoma, seroma, infection, skin necrosis, capsular contracture, implant loss |
| change of baseline patient quality of life after 3 and 6 months | up to two weeks after surgery (=baseline), 3 and 6 months after surgery | questionnaire |
| change of baseline cosmetic outcome after 3 and 6 months | up to two weeks after surgery (=baseline), 3 and 6 months after surgery | four point Harris Scale (1=poor, 4=excellent) |
| change of baseline thickness of the tissue overlying the implant at the lower pole after 3 and 6 months | up to two weeks after surgery (=baseline), 3 and 6 months after surgery | The thickness of the tissue covering the implant in the lower pole im mm measured by ultrasound |
Countries
Austria
Outcome results
None listed