Acellular Dermal Matrix Investigation in Breast Reconstruction
ConditionBreast Reconstruction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age22+
SponsorRTI Surgical
About this trial
Prospective, multi-center, dual-arm non-randomized clinical study in females undergoing a two-stage breast reconstruction using a pre-pectoral technique.
Eligibility criteria
Qualifiers
Genetic female
Age 22 or older at time of consent
Undergoing immediate breast reconstruction
2 stage breast reconstruction using pre pectoral technique
Disqualifiers
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
Trial design
Treatments tested in this trial
- Acellular Dermal Matrix (Cortiva Tissue Matrix)
Treatment groups
467 Participants
are divided into 2 treatment groupsSponsors and collaborators
RTI Surgical
Lead sponsor
MCRA
Collaborator
Source ClinicalTrials.gov