Clinical trial · Observational
Polyurethan Versus Non-polyurethan Covered Implants in Combination With Radiotherapy
Retrospective International Multicenter Study Comparing Polyurethan Versus Non-polyurethan Covered Implants in Immediate Prepectoral Implant-based Breast Reconstruction in the Setting of Postmastectomy Radiotherapy: the PRExRT Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Mastectomy; Lymphedema | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiotherapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- PU covered implants
- description
- prepectoral IBBR with a PU covered implant followed by radiotherapy
- interventionNames
- Procedure: Radiotherapy
- label
- non-PU covered implants
- description
- prepectoral IBBR with a non-PU covered implant followed by radiotherapy
- interventionNames
- Procedure: Radiotherapy
Primary outcomes (1)
- measure
- capsular contracture
- timeFrame
- 2-6 years post-surgery
- description
- capsular contracture rate in women with IBBR in combination with RT comparing the use of PU with non-PU implants
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available