NCT05449691

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University Hospitals of Derby and Burton NHS Foundation Trust · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Immediate breast reconstruction in women undergoing removal of the whole breast for cancer or risk reduction is most commonly done using breast implants. Surgeons often use a sheet of mesh to cover the implant as standard treatment. It acts like an internal bra and supports the implant and re-creates a natural looking breast. Natural(biological) or man-made (synthetic) meshes are used routinely in the NHS. Biological ones are made from animal tissue (pig, cow) that have been made safe to use in people and are costly. Synthetic meshes are made from net-like fabric and cost less. The choice about which mesh to use depends on surgeons' personal experience and how much money the hospital has for these operations. The two meshes may have different acceptability issues for patients because of their personal values, religious beliefs, ethnic background or views on animal welfare. A large UK review of breast reconstruction with implants gathered information up to 3 months after surgery on the use and outcomes of the two meshes. This suggests that both may be equally safe in the short-term. However, this information can be improved by comparing the meshes side-by-side and looking at how safe they are long-term. This is important as some side-effects only appear later after surgery. Clinicians do not know how outcomes impact on patients' health and well-being. The best proof would come from a randomised surgical study, where a computer allocates patients to receive either the biological or synthetic mesh. Investigators will measure how patients feel, how their health is, and record if they have any side-effects from the reconstructive surgery. This type of study would tell us how good each mesh is and if they are safe long-term. Before starting such a study, investigators will run a smaller one that will help us understand if patients and surgeons would be comfortable taking part.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	One-stage immediate breast reconstruction	One-stage mesh assisted implant breast reconstruction

Timeline

• Start date: 2023-11-02
• Primary completion: 2026-04-30
• Completion: 2026-04-30
• First posted: 2022-07-08
• Last updated: 2025-09-10

Locations

5 sites across 1 country: United Kingdom