MAP-BRA -1
Research type
Research Study
Full title
A Mesh SAfety Platform for Immediate Implant based BReAst Reconstruction (MAP-BRA) - Project 1. A multicentre prospective cohort study to evaluate the safety and effectiveness of Fortiva porcine acellular dermal matrix in immediate implant based breast reconstruction
IRAS ID
261822
Contact name
Julia Henderson
Contact email
Sponsor organisation
Royal Liverpool & Broadgreen University Hospitals Trust
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Breast reconstruction is offered to patients having a mastectomy and can be done at the same operation (an immediate reconstruction) or at a later date (delayed reconstruction). Silicone implants are the most common way of reconstructing breasts in patients having immediate reconstruction. This is commonly done using a mesh. Meshes can be made from man-made material (synthetic mesh) or from human or animal tissue that has been treated (biological mesh). A pocket is created to hold the implant in place underneath the skin. The upper part of the pocket is often formed by lifting the pectoral (chest wall) muscle. The lower part of the implant is supported by a mesh. This is called sub-pectoral reconstruction. Another alternative is to make the whole pocket from mesh and place this on top of the muscle, known as pre-pectoral reconstruction. This is a newer technique and is also being assessed in this study.
Many new mesh products continue to be developed to try and improve the results of implant reconstructions. These products need to be assessed to ensure that they are safe and effective.
The purpose of this study is to monitor and collect information about a new mesh designed for breast reconstruction with implants. Information about complications that occur as a result of the surgery will be collected. The main way of measuring the safety of the mesh will be the number of patients who need to have their implant removed because of a complication from the surgery. Details of complications after the surgery will be collected at 3 months and 18 months. This will be compared with results from a group of 2000 patients who have had breast reconstruction with mesh and implants. Patients and surgeons will be asked for their feedback on the result of the operation.
This study design could then be used to test new meshes that are produced for implant reconstruction to ensure that every new product has reliable safety information before it is widely used.Lay summary of study results: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fwww.isrctn.com%252FISRCTN16902075%253Fq%253Dmap%252520bra%2526filters%253D%2526sort%253D%2526offset%253D1%2526totalResults%253D1%2526page%253D1%2526pageSize%253D10%2FNBTI%2Fs7q-AQ%2FAQ%2Feb34e6f8-ca95-4bdf-9906-1354d857a757%2F1%2F9kp56VjTnq&data=05%7C02%7Cliverpoolcentral.rec%40hra.nhs.uk%7C65c02f1422fb43c4d03d08dde8a586bb%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638922519806465694%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=6rwLMP4t2KshEC%2Bk%2Fg%2Fey%2FNqBRtgnK1k%2FmFMwQXIUzI%3D&reserved=0
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
19/NW/0352
Date of REC Opinion
23 Jul 2019
REC opinion
Further Information Favourable Opinion