Trial Parameters
Brief 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 Criteria
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 their body within 30 days. * Has a Body Mass Index (BMI) \< 14 or \> 40. * Is pregnant or is nursing; or plans to become pregnant during the course of the study. * Has any connective tissue/autoimmune disorder or rheumatoid disease. * Has known allergies to study device materials. * Is participating in another interventional research study that may interfere with study endpoints. * Has limited life exp