Clinical Trial

Biological Matrices Versus Synthetic Meshes

Study acronym: BIOSYM
Recruiting
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Record status
This record was last updated September 10, 2025 (before its estimated April 30, 2026 completion). Its status may not reflect the trial's current state.
Summary
In this feasibility study, 60 women undergoing reconstruction will be randomly allocated to receive biological or synthetic mesh and followed for 6 months. The findings will tell us if patients and surgeons are comfortable with not being able to choose which mesh is used for the operation. In the larger surgical study, the investigators plan to measure patients' satisfaction with the reconstruction, patients' quality of life, complications from the operation and costs over 5 years.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2022-07-04; most recent amendment 2025-09-03.
Status change: Not Yet Recruiting → Recruiting 2023-11-09
Trial Details
NCT Number NCT05449691
Lead Sponsor University Hospitals of Derby and Burton NHS Foundation Trust
Conditions Breast Cancer
Enrollment 60 participants
Start Date 2023-11-02
Primary Completion 2026-04-30 (estimated)
Study Completion 2026-04-30 (estimated)
Updated on ClinicalTrials.gov 2025-09-10