Biological Matrices Versus Synthetic Meshes
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.
Conditions studied
Breast Cancer
About this study
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.
Interventions
- Procedure: One-stage immediate breast reconstruction — One-stage mesh assisted implant breast reconstruction
Primary outcomes
- Clinician acceptance (2 years)
- Patient acceptance (2 years)
- Recruitment rate (2 years)
- Compliance with allocated intervention (2 years)
Eligibility information
Study locations
- University Hospitals of Derby and Burton NHS Foundation Trust, Derby, DE22 3NE 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
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.