Study to Assess Perfusion and Patient Satisfaction in Nipple-Areola Mastectomy With Immediate Reconstruction

The primary hypothesis of this study is to determine which of two incision sites
(inframammary fold incision or the lateral radial incision) provides a more robust blood
supply to the skin envelope during nipple-sparing mastectomy with immediate reconstruction.

Following education about the trial and informed consent, patients will be randomized to one
of the two incisions. If their surgeon recommends a particular incision, there is also a
non-randomized cohort. Patients will complete the Breast Q, a questionnaire prior to surgery
and three months after surgery to capture quality of life data. During the surgery,
laser-assisted fluorescent angiography will be performed three times to look at blood
perfusion with the Spy Elite imaging device.

Patients will be required to return for postoperative follow up visits. All patients will be
seen approximately one week, three weeks, and six weeks after surgery. Patients with a
direct implant will finish the study at their three month post-operative visit. Patients
with an expander will finish the study three months after their final implant is placed.