Reconstruction Outcomes in Immediate Post-mastectomy Breast Reconstruction With ADM

This is a level one, prospective, randomized, controlled multi-center clinical study
comparing two types of acellular dermal matrices (ADMs) currently used in immediate
post-mastectomy prosthetic breast reconstruction. Comparison of these two ADMs will be made
in the areas of reconstructive clinical outcomes and aesthetic outcomes. Patients will be
randomized into one of two ADM groups as part of their immediate post-mastectomy breast
reconstruction. Patients in both groups will be followed for twelve months after their
reconstructive surgery. Clinical outcomes will be documented at 1 month, 3 months, 6 months
and 12 months following breast reconstructive surgery. For one-stage breast reconstruction,
aesthetic outcomes will be assessed and documented at 6 and 12 months following implant
placement. For two-stage reconstruction, patients will be evaluated for aesthetic outcomes at
a time point 6-12 months following expander-to-implant exchange if it does not coincide with
the 12 month post-mastectomy visit.

Inclusion Criteria:

1. Scheduled to undergo immediate, post-mastectomy, tissue assisted breast
reconstruction, Reconstruction shall be either one-stage (direct-to-implant) or
two-stage, unilateral or bilateral, prophylactic or therapeutic

2. Females at least 18 years of age

3. Non-smokers, former smokers and/or smokers who have not smoked within 1 month before
surgery, and who agree to not smoke or utilize e-cigarettes during the post-operative
period

4. Have signed a written informed consent

5. Have the ability to understand and comply with the requirements and follow-up time
points of the study

Exclusion Criteria:

1. Previous breast surgery with the exception of biopsy

2. Previous radiation treatment in either breast at any time

3. Undergoing autologous breast reconstruction

4. Pre-pectoral implant placement

5. Undergoing delayed reconstruction

6. Requiring Wise pattern reduction of mastectomy skin flap

7. History of chronic steroid use within the past 6 months

8. History of HIV positive

9. Previous organ transplant

10. Pregnant or lactating females

11. Clinically significant systemic disease, as determined by the investigator, which
could affect study participation or study results