Randomised trial comparing Biological Matrices with Synthetic Meshes
Research type
Research Study
Full title
BIOSYM - A Feasibility Randomised Controlled Trial Comparing Biological Matrices with Synthetic Meshes in Women Undergoing One Stage Implant Based Breast Reconstruction
IRAS ID
315581
Contact name
Amit Goyal
Contact email
Sponsor organisation
University Hospitals of Derby and Burton NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 11 months, 31 days
Research summary
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.
We do not have long-term data on the two types of meshes. This is important as some side-effects only appear later after surgery. We also 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. The proposed main randomised study will measure how patients feel, how their health is, and record if they have any side-effects from the reconstructive surgery.
Before starting such a study, we would like to run this smaller feasibility study to understand if patients and surgeons would be comfortable taking part. In the smaller 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.
REC name
London - Camberwell St Giles Research Ethics Committee
REC reference
22/LO/0554
Date of REC Opinion
19 Oct 2022
REC opinion
Further Information Favourable Opinion