Acellular Dermal Matrix Investigation in Breast Reconstruction
Trial Parameters
Brief Summary
Prospective, multi-center, dual-arm non-randomized clinical study in females undergoing a two-stage breast reconstruction using a pre-pectoral technique.
Eligibility Criteria
Inclusion Criteria: * Genetic female * Age 22 or older at time of consent * Undergoing immediate breast reconstruction * 2 stage breast reconstruction using pre pectoral technique * Nipple or skin sparing mastectomy * Willing and capable of providing informed consent * Able to comply with study requirements Exclusion Criteria: * Planned concurrent reconstruction with pedicled flaps or free tissue * Pregnant or breast feeding * Investigator has determined tissue is unsuitable for two-stage breast reconstruction * History of psychological characteristics that may be incompatible with the surgical procedure and the prosthesis * Any serious and/or unstable pre-existing medical disorder or other conditions that could interfere with the subject's safety, the informed consent process, or compliance with the study protocol, in the opinion of the investigator * Vulnerable subject populations * Currently participating in another clinical trial that would have the potential to interfere or confli