prophylactic mastectomy because of a BRCA1 and BRCA2 mutation and capsular contracture after insertion of a breast implant C50.9
Conditions
Interventions
Group 1: Two independent groups of patients will be observed within the study:
Group A: patients with a planned skin sparing mastectomy and immediate reconstruction with an implant and Epiflex without
Sponsors
Nord-Ostdeutsche Gesellschaft für Gynäkologische Onkologie e.V. (NOGGO e.V.)
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: signed permission form, age over 18 years, group A: Women who are suitable to obtain a skin and nipple-sparing mastectomy and immediate reconstruction with an implant and an acellular dermal matrix (Epiflex) group B Patients with planned revision surgery for capsular contracture
Exclusion criteria
Exclusion criteria: for group A and B: autoimmune diseases, patients with known contraindications to net supported- or plastic reconstructive breast surgery, pregnant or nursing women, participation in another clinical study for group A: patients with previous breast reconstruction, preceding radiotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of severe complications (loss of the implant) immediately after surgery, after 1 week, after 1 month, after 3 months, after 6 months and after 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Directly after the surgery, 1 week, 1 month, 3 months, 6 months and 12 months after the surgery the following data will be recorded in two groups : rate of seroma, skin redness over the net, patient satisfaction (scale 1 to 6 in the case report form and EORTC BR23 questionnaire), satisfaction of the surgeon (scale 1 to 6 in the case report form), capsular contracture rate, other complications | — |
Countries
Germany
Contacts
Public ContactMaren Keller
Nord-Ostdeutsche Gesellschaft für Gynäkologische Onkologie e.V. (NOGGO e.V.)
Outcome results
None listed