Mastectomy; LymphedemaPRExRTNCT06747065
Polyurethan Versus Non-polyurethan Covered Implants in Combination With Radiotherapy
An observational study of Mastectomy; Lymphedema and Breast Cancer, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mastectomy; Lymphedema, Breast Cancer
- What is being tested?
- Radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteSwitzerland
- Study dates
- 10 Dec 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: data will be collected from patient hospital records, including approximately 30 international sites
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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
- Being tested
- Radiotherapy
- Keywords
- immediate implant-based breast reconstruction (IBBR), postmastectomy radiotherapy (PMRT), Polyurethan covered implant
- Medical subject headings
- Lymphedema, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyProcedure or surgery
Radiotherapy post-mastectomy prepectoral implant-based breast reconstruction (IBBR)
| Study group | Role | What they receive |
|---|---|---|
| PU covered implants | prepectoral IBBR with a PU covered implant followed by radiotherapy Receives: Procedure: Radiotherapy | |
| non-PU covered implants | prepectoral IBBR with a non-PU covered implant followed by radiotherapy Receives: Procedure: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
capsular contracture
capsular contracture rate in women with IBBR in combination with RT comparing the use of PU with non-PU implants
Measured: 2-6 years post-surgery
Secondary outcomes (5)
implant loss rate
To determine the implant loss rate in women with IBBR in combination with RT comparing the use of PU with non-PU implants
Measured: 2-6 years post-surgery
re-surgery rate
To determine the re-surgery rate in women with IBBR in combination with RT comparing the use of PU with non-PU implants
Measured: 2-6 years post-surgery
hematoma rate
To determine the hematoma rate in women with IBBR in combination with RT comparing the use of PU with non-PU implants
Measured: 2-6 years post-surgery
infection rate
To determine the infection rate in women with IBBR in combination with RT comparing the use of PU with non-PU implants
Measured: 2-6 years post-surgery
implant exchange rate
To determine the implant exchange rate in women with IBBR in combination with RT comparing the use of PU with non-PU implants
Measured: 2-6 years post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start10 Dec 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mastectomy; LymphedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Walter Weber, Prof. Dr., Principal investigator, Universitätsspital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06747065
- Sponsor's protocol ID
- 2024-02438; bb24weber3
- Acronym
- PRExRT
- Status last verified
- Jan 2026
- First submitted
- 18 Dec 2024
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06747065
- Acronym / sponsor ID
- PRExRT / 2024-02438; bb24weber3
- Conditions
- Mastectomy; Lymphedema, Breast Cancer
- Keywords
- immediate implant-based breast reconstruction (IBBR), postmastectomy radiotherapy (PMRT), Polyurethan covered implant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 24 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PU covered implants | – | Procedure: Radiotherapyprepectoral IBBR with a PU covered implant followed by radiotherapy |
| non-PU covered implants | – | Procedure: Radiotherapyprepectoral IBBR with a non-PU covered implant followed by radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- data will be collected from patient hospital records, including approximately 30 international sites
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiotherapyRadiotherapy post-mastectomy prepectoral implant-based breast reconstruction (IBBR) | Procedure or surgery | PU covered implants, non-PU covered implants |
Primary outcome
capsular contracture
Time frame: 2-6 years post-surgery
capsular contracture rate in women with IBBR in combination with RT comparing the use of PU with non-PU implants
5 secondary outcomes
implant loss rate
Time frame: 2-6 years post-surgery
re-surgery rate
Time frame: 2-6 years post-surgery
hematoma rate
Time frame: 2-6 years post-surgery
infection rate
Time frame: 2-6 years post-surgery
implant exchange rate
Time frame: 2-6 years post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Walter Weber, Prof. Dr. principal investigator
Universitätsspital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mastectomy; Lymphedema and Breast Cancer, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
capsular contracture (time frame: 2-6 years post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.