Clinical Research Directory
Browse clinical research sites, groups, and studies.
Biological Matrices Versus Synthetic Meshes
Sponsor: University Hospitals of Derby and Burton NHS Foundation Trust
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.
Official title: BIOSYM - A Feasibility Randomised Controlled Trial Comparing Biological Matrices With Synthetic Meshes in Women Undergoing One Stage Implant Based Breast Reconstruction
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2023-11-02
Completion Date
2026-04-30
Last Updated
2025-09-10
Healthy Volunteers
No
Conditions
Interventions
One-stage immediate breast reconstruction
One-stage mesh assisted implant breast reconstruction
Locations (5)
University Hospitals of Derby and Burton NHS Foundation Trust
Derby, United Kingdom
Wycombe Hospital
High Wycombe, United Kingdom
Castle Hill Hospital
Hull, United Kingdom
University Hospitals of Leicester NHS Trust
Leicester, United Kingdom
Nottingham City Hospital
Nottingham, United Kingdom