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Acellular Dermal Matrix Investigation in Breast Reconstruction
RecruitingHealthy volunteers welcome
Who can join
Ages 22 and older · Women · Healthy volunteers welcome
Full 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 conflict with the treatment, follow-up, or objectives of this study * Prior history of neoadjuvant radiotherapy to the reconstruction site or chest wall * Active abscess or infection in the intended reconstruction site * Residual gross tumor at the intended reconstruction site * Active use of any tobacco/nicotine products * Has body mass index (BMI) \>35 * Uncontrolled diabetes defined as HbA1c ≥7 within 3 months prior to stage 1 procedure * Is currently taking medications including systemic steroids
About the study
Prospective, multi-center, dual-arm non-randomized clinical study in females undergoing a two-stage breast reconstruction using a pre-pectoral technique.
What is being tested
- Acellular Dermal Matrix (Cortiva Tissue Matrix) (device)
Sponsor: RTI Surgical · Participants: 467 · Started: Nov 22, 2024
Contact the study team
- Ana Villagomez · Phone: 202-552-6013
Official record on ClinicalTrials.gov — NCT06456554
Locations in the U.S.
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.