Acellular Dermal Matrix Investigation in Breast Reconstruction

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 surgicalprocedure and the prosthesis

• Any serious and/or unstable pre-existing medical disorder or other conditions thatcould interfere with the subject's safety, the informed consent process, orcompliance with the study protocol, in the opinion of the investigator

• Vulnerable subject populations

• Currently participating in another clinical trial that would have the potential tointerfere 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

• Is scheduled to undergo post-operative radiation therapy