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NCT06216106: IBR-PPBR

Data Collection of Prepectoral Breast Reconstruction With Polyurethane Implantes

Completed Last updated 22 January 2024
What this trial tests

trial testing Prepectoral breast reconstruction with polyurethane implants in Prepectoral Breast Reconstruction in 237 participants. Completed in 5 October 2023.

Timeline
18 March 2020
Primary endpoint
22 December 2022
5 October 2023

Quick facts

Lead sponsorEuropean Institute of Oncology
StatusCompleted
Study typeOBSERVATIONAL
Enrollment237
Start date18 March 2020
Primary completion22 December 2022
Estimated completion5 October 2023
Sites1 location across Italy

Drugs / interventions tested

Conditions studied

Sponsor

European Institute of Oncology

Who can join

Eligibility, female only, with Prepectoral Breast Reconstruction or Breast Reconstruction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this observational study is to learn about correct surgical indications and long-term complications in patient with immediate prepectoral breast reconstruction with polyurethane implants. The main question it aims to answer are: what are the correct indications for this type of reconstruction? what is the complications rates? are the complications affected by pre and post operative radiotherapy? It's a retrospective study of all the patients that received prepectoral breast reconstruction with polyurethane implants without any exclusion factors. Researchers will compare the non-irradiated group with the patients with pre and post radiation therapy.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Outcomes, indications and predictive factors for complications in postmastectomy prepectoral reconstructions with polyurethane foam-coated implants.
    Lisa A, Riccardi F, Alessandri-Bonetti M, Mazzocconi L, et al · · 2025 · cited 1× · PMID 40695028 · DOI 10.1016/j.breast.2025.104520

Verify or expand the search:

Other recruiting trials for Prepectoral Breast Reconstruction

Currently open trials in the same condition.

Other European Institute of Oncology trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06216106.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing