Polyurethan Versus Non-polyurethan Covered Implants in Combination With Radiotherapy (NCT06747065) | Clinical Trial Compass
CompletedNot Applicable
Polyurethan Versus Non-polyurethan Covered Implants in Combination With Radiotherapy
Switzerland1,000 participantsStarted 2024-12-10
Plain-language summary
The purpose of this multicenter retrospective cohort study is to determine the effect of radiotherapy on capsular contraction and implant loss rates in patients undergoing prepectoral immediate implant-based breast reconstruction (IBBR) comparing Polyurethan (PU) and non-PU covered implants.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patients with signed General consent or study specific consent form
* Patients with confirmed diagnosis of primary or recurrent breast cancer
* Patients undergoing nipple - or skin-sparing mastectomy with prepectoral IBBR (all types of implants, with or without mesh, all types of biologic and synthetic mesh, one- or two- stage) in the setting of PMRT (or any type or RT before reconstruction) between 2016 and 2022.
* Patients undergoing two-stage IBBR with radiotherapy to the expander before reconstruction with implant.
* Patients with recurrent breast cancer after breast conserving surgery and radiotherapy.
* Follow up must be at least 2 years after IBBR.
* Patients aged 18 and above will be eligible for inclusion.
Exclusion Criteria:
* Patients who have explicitly refused the further use of their data through a consent declaration.
* Patients undergoing subpectoral IBBR or autologous reconstruction as initial type of reconstruction.
* No radiotherapy.