Acellular Dermal Matrix Investigation in Breast Reconstruction

Acellular Dermal Matrix Investigation in Breast Reconstruction

Prospective, multi-center, dual-arm non-randomized clinical study in females undergoing a two-stage breast reconstruction using a pre-pectoral technique.

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