Overview

Prospective, multicenter, randomized, controlled trial evaluating the safety and effectiveness of an absorbable antibacterial matrix device in two stage prepectoral alloplastic breast reconstruction.

Eligibility

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 expectancy or co-morbid conditions, social/psychological problems, or cognitive impairments that precludes participation.
• Has a medical condition or is taking medications that would result in elevated risk and/or affect the validity of the study.
• Intraoperative assessment demonstrates unfavorable conditions (i.e., poor mastectomy skin flap thickness or viability) for immediate, two-stage post-mastectomy alloplastic prepectoral reconstruction in any breast.