Trial Information

The Use of Laser-Assisted Indocyanine Green Dye Angiography to Predict Intraoperative Mastectomy Skin Flap Viability During Breast Reconstruction

The investigators current rate of the development of all-inclusive mastectomy skin necrosis
was approximately 41%. This means that current methods of clinical assessment fail to
identify regions of mastectomy skin with poor blood flow that lead to necrosis in 41% of
patients. The investigators know that using the SPY imaging system is more sensitive for
necrosis than clinical assessment. With SPY Q analysis the investigators hope to obtain 90%
sensitivity, 100% specificity at absolute perfusion unit values identified in the previous
study. The investigators do not anticipate obtaining a 0% all-inclusive necrosis rate but
do believe they can eliminate all clinically significant necrosis that would result in
operative debridement or removal of implant. The less severe forms of necrosis including
epidermolysis and incisional necrosis are self-limiting and usually do not require invasive
interventions.