Breast reconstruction
Conditions
Interventions
Patients in both cohorts will receive a two-stage implant-based breast reconstruction after mastectomy. In the second stage, the intervention cohort will receive a polyurethane covered silicone implan
Sponsors
Erasmus MC
Eligibility
Inclusion criteria
Inclusion criteria: • Female • Age of 18 years or older • Mastectomy is performed • Eligible for two-stage implant-based breast reconstruction in accordance with the Dutch national breast reconstruction guideline • First step of two-stage implant-based breast reconstruction (placement of tissue expander) is successfully completed • Able to understand the patient information sheet, to complete questionnaires and to provide written informed consent
Exclusion criteria
Exclusion criteria: • Additional use of autologous tissues for the breast reconstruction • The use of acellular dermal matrix or synthetic mesh • Prior irradiation of the breast or an indication for postoperative radiotherapy • Revision surgery or tertiary breast reconstruction • Inflammatory carcinoma • Evidence of distant metastases • Active infection at the surgical field or distant locations
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| capsular contracture rate | — |
Secondary
| Measure | Time frame |
|---|---|
| revision surgery rates, complication rates, patient satisfaction and quality of life, user friendliness | — |
Contacts
Public ContactXavier Harmeling
Postbus 2040, 3000 CA Rotterdam, intern postadres Ee-15.89
Outcome results
None listed