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
You may not be if
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
Clareo Health | Acellular Dermal Matrix Investigation in Breast Reconstruction
