Biological Matrices Versus Synthetic Meshes
BIOSYM - A Feasibility Randomised Controlled Trial Comparing Biological Matrices With Synthetic Meshes in Women Undergoing One Stage Implant Based Breast Reconstruction
University Hospitals of Derby and Burton NHS Foundation Trust
60 participants
Nov 2, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria1
- Female age ≥ 18 Women undergoing mastectomy and immediate one-stage mesh assisted implant breast reconstruction as standard treatment
Exclusion Criteria1
- Revision reconstruction surgery Delayed reconstruction surgery
Interventions
One-stage mesh assisted implant breast reconstruction
Locations(5)
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NCT05449691