NCT06747065

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (actual)
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Breast cancer affects 2.6 million women worldwide annually, with surgery as the standard treatment for 95% of cases. Rising mastectomy rates, due to advanced diagnostic tools and patient preferences, make immediate breast reconstruction crucial for improving quality of life for around 650,000 women each year. Prepectoral implant-based breast reconstruction (IBBR) has become a preferred approach due to advancements like synthetic meshes, acellular dermal matrices (ADM), and polyurethane (PU) covered implants, which show promise in reducing complications such as capsular contracture, implant loss, and breast animation deformities. Radiotherapy (RT), however, increases these risks, especially for capsular contracture, underscoring the need for strategies to mitigate such outcomes. This multicenter retrospective cohort study will investigate the impact of radiotherapy on complications such as capsular contracture and implant loss in patients with breast cancer who underwent mastectomy and prepectoral IBBR. The study will compare outcomes between PU and non-PU covered implants using data from approximately 30 international sites. Patient information will be extracted from hospital records, coded for confidentiality, and analyzed statistically to achieve the study's objectives of improving post-reconstruction outcomes and quality of life for patients.

Conditions

• Mastectomy; Lymphedema
• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	Radiotherapy	Radiotherapy post-mastectomy prepectoral implant-based breast reconstruction (IBBR)

Timeline

• Start date: 2024-12-10
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2024-12-24
• Last updated: 2026-01-14

Locations

1 site across 1 country: Switzerland