Post-market Surveillance Study to Evaluate the Quality of Life and the Safety and Effectiveness of the TIGR® Matrix After Reconstructive Breast Surgery
This study is checking how a special type of surgical mesh, called the TIGR® Matrix, performs when used in breast reconstruction surgery. Many women have breast reconstruction after breast cancer surgery, often using implants. This study wants to understand how this mesh affects their quality of life. Researchers will use a questionnaire called BREAST-Q to gather this information. They also want to confirm that the TIGR® Matrix, which is designed to be fully absorbed by the body over time, is both safe to use and effective in helping with the reconstruction. It's an observational study, meaning researchers will look at the experiences of patients who are already having this procedure.
At a glance
What is this study about?
This study is all about helping women who have breast reconstruction surgery. Sometimes, after having an operation to remove one or both breasts because of cancer or a high risk of cancer (this is called a mastectomy), women choose to have surgery to rebuild their breast shape. This is often done using breast implants.
In some of these reconstruction surgeries, a special type of mesh material called the TIGR® Matrix is used. This mesh provides support during the healing process and is designed to slowly dissolve in the body over time. The main goals of this study are to see how women who have this mesh feel about their quality of life after surgery and to make sure the TIGR® Matrix is working well and is safe.
The researchers will collect information on patients' experiences using a special questionnaire designed to understand quality of life after breast surgery. They will also keep an eye on how well the mesh works and if there are any issues or side effects. This information helps doctors and patients make informed decisions about breast reconstruction options in the future.
Key takeaways
- Checks how a special mesh (TIGR® Matrix) works in breast reconstruction.
- Aims to understand patients' quality of life after surgery.
- Observational study, meaning no changes to your planned treatment.
- Involves answering questionnaires about your experience.
- Helps improve knowledge for future breast cancer patients.
- Participation is voluntary and you can withdraw at any time.
Who may be eligible?
This study is looking for women who are having breast reconstruction surgery using implants after a mastectomy. This could be due to having breast cancer, a pre-cancerous condition, or a high risk of breast cancer in their family. You must also be 18 years or older and understand what the study involves.
You wouldn't be able to join if you are pregnant or breastfeeding, or if you know you are allergic or intolerant to this type of mesh. Other reasons you might not be able to take part include having advanced breast cancer that has spread, uncontrolled diabetes, or certain blood conditions. You also can't be in this study if you're already taking part in another surgery-related study that could affect the results of this one.
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 over?
- Are you having breast reconstruction with implants after a mastectomy?
- Are you generally in good health?
- Are you NOT pregnant or breastfeeding?
- Do you NOT have advanced breast cancer that has spread?
- Have you NOT had an allergic reaction to surgical mesh before?
What does participation involve?
If you decide to take part, doctors will gather information about your health and your experience with the TIGR® Matrix during your standard breast reconstruction surgery. You will be asked to complete questionnaires, like the BREAST-Q, a few times during your recovery to understand how the surgery and mesh affect your quality of life. The decision to use the TIGR® Matrix in your surgery will have been made by your doctor before you even consider joining this study. Your participation simply means allowing researchers to collect information about your progress over time.
Potential risks and benefits
Locations (5)
- GRN-Klinik WeinheimVerified postcodeWeinheim, Germany· Active not recruiting
- Klinik und Poliklinik für Frauenheilkunde Technische Universität MünchenVerified postcodeMünchen, Germany· Recruiting
- Agaplesion Markus Krankenhaus FrankfurtVerified postcodeFrankfurt am Main, Germany· Recruiting
- Evangelisches Krankenhaus WeselVerified postcodeWesel, Germany· Recruiting
- Krankenhaus St. Elisabeth und St. Barbara Halle (Saale) GmbHVerified postcodeHalle, Germany· Recruiting
Common questions
What is the TIGR® Matrix?
It's a special surgical mesh used in breast reconstruction after mastectomy. It provides support and is designed to dissolve over time.
Will my surgery change if I join this study?
No, your surgery plan will not change. The decision to use the TIGR® Matrix is made by your doctors before you even consider joining the study.
What kind of questions will I be asked?
You'll fill out questionnaires, like BREAST-Q, which ask about your experiences and how you feel about your quality of life after surgery.
How long will I be involved in the study?
The study will collect information about your progress over a period, but the length isn't specified. It involves follow-up appointments and questionnaires after your surgery.
Why is this study important?
It helps medical professionals understand how well the TIGR® Matrix works and how it affects patients' quality of life, which can help others in the future.
How to find out more
Marc Thill, Prof.
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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