The ARIA Research Study

STUDY BASICS

Are you planning to undergo two-stage post-mastectomy breast reconstruction? You may be eligible for a research study testing the safety and effectiveness of the Melodi Matrix, an investigational device made of an absorbable suture material with antibiotic coating. Participation involves 8 study visits over approximately 12 months. Compensation is provided.

STUDY PURPOSE

This research study is testing the safety and effectiveness of the Melodi Matrix, an investigational device made of an absorbable suture material with antibiotic coating. The goal of this research study is to evaluate the safety and effectiveness of the Melodi Matrix during immediate, two-stage post mastectomy prepectoral breast reconstruction.  

COULD THIS STUDY BE RIGHT FOR YOU?

You may be eligible if you:

• are scheduled to undergo a mastectomy followed by immediate breast reconstruction with a tissue expander placed over the muscle.
• do not have a history of breast cancer surgery or radiation.
• are not pregnant or nursing and do not plan to get pregnant during the study.
• do not have an active infection.
• do not have a BMI of less than 14 or greater than 40.
• do not have allergies to vicryl sutures or antibiotics present on the Melodi Matrix.
• do not have any connective tissue disorders managed by medication.

WHAT PARTICIPANTS CAN EXPECT

• Participants will be randomly assigned to one of two study groups: tissue expander implant with the Melodi Matrix or tissue expander implant without the Melodi Matrix. Participants are more likely (~70% chance) to be assigned to the Melodi Matrix study group.
• Participants will need to participate in the study for approximately 12 months and includes approximately 8 study visits to the study center. Most of these visits are routine visits and would occur whether or not they take part in the study, such as surgery for placing a tissue expander, tissue expander fill visits, exchange of their tissue expander, and final follow up visits. 
• Participants will need to fill out a patient diary for the first 30 days after their tissue expander surgery. At three different study visits, they will need to fill out a Breast Questionnaire, which asks approximately 15 questions.