Absorbable Antibacterial Soft Tissue Support in Breast Reconstruction With Infection Outcomes Assessment (ARIA)
Melodi Health, Inc.
Summary
Prospective, multicenter, randomized, controlled trial evaluating the safety and effectiveness of an absorbable antibacterial matrix device in two stage prepectoral alloplastic breast reconstruction.
Eligibility
- Age range
- 22+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Female. * Age 22 or older at the time of enrollment. * Is scheduled to undergo unilateral or bilateral mastectomy (including prophylactic) with immediate two-stage post-mastectomy alloplastic prepectoral breast reconstruction. * Is able to and willing to comply with the study requirements and providing informed consent. Exclusion Criteria: * Has prior history of neoadjuvant radiotherapy. * Has had prior history of failed tissue expansion or breast implantation at the intended reconstruction site. * Has an active abscess or infection requiring antibiotics anywhere in th…
Interventions
- DeviceAbsorbable Antibacterial Matrix
Soft tissue support coated with antibiotics
Locations (10)
- Stanford UniversityPalo Alto, California
- University of Michigan HealthAnn Arbor, Michigan
- Mayo ClinicRochester, Minnesota
- Northwell HealthStaten Island, New York
- The Ohio State UniversityColumbus, Ohio
- UPMCPittsburgh, Pennsylvania