Biological Matrices Versus Synthetic Meshes
This study is comparing two types of mesh used in breast reconstruction surgery after breast cancer: natural, animal-based meshes and man-made, synthetic meshes. The main purpose is to find out if it's acceptable for patients and surgeons not to choose which type of mesh is used. Researchers want to ensure that both types of mesh are safe and effective in the long run. They will also look at how satisfied patients are with their reconstruction, their overall quality of life, any problems that might arise, and the costs involved. This initial, smaller study will help decide if a larger study comparing these meshes in more detail would be possible and helpful.
At a glance
What is this study about?
When women have surgery to remove their whole breast (a mastectomy) due to cancer or to prevent it, they often have immediate breast reconstruction. This many times involves using a breast implant. Surgeons usually place a sheet of mesh around the implant. Think of this mesh like an internal bra. It helps to support the implant and create a natural-looking breast shape.
There are two main types of meshes used: natural (biological) ones and man-made (synthetic) ones. Biological meshes are made from animal tissue, like pigs or cows, but don't worry, they are specially treated to be safe for human use. These tend to be more expensive. Synthetic meshes are like a fine, net-like fabric and are generally cheaper. Currently, the choice of which mesh to use can depend on a surgeon's personal experience or how much money the hospital has. However, patients might also have their own preferences based on personal values, religious beliefs, ethnic background, or views on animal welfare.
Previous studies have looked at these meshes, and they seemed equally safe in the short-term (up to 3 months). But we don't know much about their long-term safety or how they affect patients' health and well-being over time, as some problems only appear much later. This study aims to help us understand if both types of mesh are equally good and safe in the long run. Before doing a big study, we are running a smaller one to check if patients and surgeons are comfortable with the idea of not being able to choose which mesh is used. This will help us plan a bigger study in the future.
Key takeaways
- Compares two types of mesh for breast reconstruction: natural or man-made.
- Aims to see if patients and doctors are comfortable with not choosing the mesh type.
- Will follow patients for 6 months after surgery.
- Focuses on patient comfort, safety, and results.
- This is a smaller study to help plan a larger one in the future.
Who may be eligible?
To be part of this study, you need to be a woman aged 18 or older. You should be planning to have surgery to remove your whole breast (a mastectomy) and then, in the same operation, have an immediate breast reconstruction using a mesh and an implant. This means the reconstruction is done right after the mastectomy, in one go, as part of your standard treatment.
This study is not for you if you've already had breast reconstruction surgery and are looking to have it redone. It's also not for you if your reconstruction surgery is planned for a later date, rather than immediately after the mastectomy.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you a woman aged 18 or older?
- Are you having a mastectomy for cancer or risk reduction?
- Are you planning to have immediate breast reconstruction (at the same time as your mastectomy)?
- Will your reconstruction use a mesh and an implant?
- Are you NOT having a revision (redo) reconstruction surgery?
- Are you NOT having delayed reconstruction (reconstruction at a later date)?
What does participation involve?
If you take part in this study, you'll be randomly assigned by a computer to receive either a biological (animal-based) or a synthetic (man-made) mesh during your immediate breast reconstruction surgery. You and your surgeon won't be able to choose which type of mesh you get. After your surgery, the researchers will follow your progress for 6 months. During this time, they will check how you are recovering, if you are comfortable with the outcome, and record any side effects. This will involve regular check-ups and answering questions about your recovery and how you feel. The aim is to understand how you and your surgeon feel about not having a choice of mesh.
Potential risks and benefits
Locations (5)
- University Hospitals of Derby and Burton NHS Foundation TrustVerified postcodeDerby, United Kingdom· Recruiting
- Wycombe HospitalVerified postcodeHigh Wycombe, United Kingdom· Recruiting
- Castle Hill HospitalVerified postcodeHull, United Kingdom· Recruiting
- University Hospitals of Leicester NHS TrustVerified postcodeLeicester, United Kingdom· Recruiting
- Nottingham City HospitalVerified postcodeNottingham, United Kingdom· Recruiting
Common questions
What is breast reconstruction?
Breast reconstruction is surgery to rebuild the shape of your breast after a mastectomy (surgery to remove the whole breast).
What are biological and synthetic meshes?
Biological meshes are made from animal tissue, treated to be safe. Synthetic meshes are man-made, like a strong net material.
Will I get to choose my mesh type?
No, if you join this study, a computer will randomly choose whether you receive a biological or synthetic mesh.
How long will I be followed in the study?
You will be followed for 6 months after your surgery to see how you are doing.
Why is this study important?
This study helps researchers understand if both mesh types are equally safe and effective long-term, and if not choosing a mesh type is acceptable to patients and surgeons.
How to find out more
Amit Goyal, MS, MD, FRCS
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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