Absorbable Antibacterial Soft Tissue Support in Breast Reconstruction - ARIA - Clinical Trial
What is the Purpose of this Study?
This study lasts about twelve months and includes around twelve to eighteen visits, most of which are regular visits you would have even if you were not in a study. The study is testing a device called the Melodi Matrix. It is a special mesh that has medicine to fight bacteria. The mesh is placed around tissue expanders before they are put into the body. After about nine weeks, the mesh dissolves and is absorbed by the body.
Women who are undergoing two-stage post- mastectomy breast reconstruction
Who Can Participate in the Study?
People can join this study if they are women who are older than 22 years and are scheduled to have one or both breasts removed. This can include surgery to prevent breast cancer. They must also be planning to have a type of breast reconstruction that uses tissue expanders placed above the chest muscle right after the mastectomy.
What is Involved?
This study is being done to learn if the Melodi Matrix is safe and works well. The Melodi Matrix is a special mesh that has medicine in it to fight bacteria. It is placed around tissue expanders before they are put into the body. The mesh dissolves on its own after several weeks.
Study Details
