Polyurethan Versus Non-polyurethan Covered Implants in Combination With Radiotherapy

NCT06747065 | Completed

• 1 other identifier: 2024-02438; bb24weber3
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mastectomy; Lymphedema; Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• capsular contracture

  capsular contracture rate in women with IBBR in combination with RT comparing the use of PU with non-PU implants

  2-6 years post-surgery

Secondary Outcomes (5)

• implant loss rate

  2-6 years post-surgery

• re-surgery rate

  2-6 years post-surgery

• hematoma rate

  2-6 years post-surgery

• infection rate

  2-6 years post-surgery

• implant exchange rate

  2-6 years post-surgery

Study Arms (2)

PU covered implants

prepectoral IBBR with a PU covered implant followed by radiotherapy

Procedure: Radiotherapy

non-PU covered implants

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

Procedure: Radiotherapy

Interventions

Radiotherapy PROCEDURE

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

PU covered implants; non-PU covered implants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

data will be collected from patient hospital records, including approximately 30 international sites

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Lymphedema; Breast Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Walter Weber, Prof. Dr.

  Universitätsspital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: December 24, 2024
• Study Start: December 10, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 14, 2026

Record last verified: 2026-01

Locations

CH (1)