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Polyurethan Versus Non-polyurethan Covered Implants in Combination With Radiotherapy

NCT ID: NCT06747065

Last Updated: 2024-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-10

Study Completion Date

2029-12-31

Brief Summary

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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

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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

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Mastectomy; Lymphedema Breast Cancer

Keywords

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immediate implant-based breast reconstruction (IBBR) postmastectomy radiotherapy (PMRT) Polyurethan covered implant

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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PU covered implants

prepectoral IBBR with a PU covered implant followed by radiotherapy

Radiotherapy

Intervention Type PROCEDURE

Radiotherapy post-mastectomy prepectoral implant-based breast reconstruction (IBBR)

non-PU covered implants

prepectoral IBBR with a non-PU covered implant followed by radiotherapy

Radiotherapy

Intervention Type PROCEDURE

Radiotherapy post-mastectomy prepectoral implant-based breast reconstruction (IBBR)

Interventions

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Radiotherapy

Radiotherapy post-mastectomy prepectoral implant-based breast reconstruction (IBBR)

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Walter Weber, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Universitätsspital Basel

Locations

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University Hospital Basel

Basel, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2024-02438; bb24weber3

Identifier Type: -

Identifier Source: org_study_id