Acellular Dermal Matrix Investigation in Breast Reconstruction
RTI Surgical
Summary
Prospective, multi-center, dual-arm non-randomized clinical study in females undergoing a two-stage breast reconstruction using a pre-pectoral technique.
Eligibility
- Age range
- 22+ years
- Sex
- Female
- Healthy volunteers
- Yes
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 surg…
Interventions
- DeviceAcellular Dermal Matrix (Cortiva Tissue Matrix)
non-crosslinked dermis
Locations (13)
- University of ArkansasLittle Rock, Arkansas
- City of Hope National Medical CenterDuarte, California
- University of ColoradoAurora, Colorado
- University of KansasLawrence, Kansas
- Washington UniversitySt Louis, Missouri
- Mercy HospitalSt Louis, Missouri