Cancer Clinical Trial
Official title:
Objective Flap Assessment During Reconstructive Surgery
The main purpose of this study is to test the ergonomics of an investigational imaging system that can take pictures of blood vessels under the skin. In plastic and reconstructive surgery, blood flow to tissue determines whether the tissue can be transplanted from one location to another. This new imaging device uses invisible near-infrared fluorescent light to see blood vessels that otherwise could not be seen by eye. This study will test the system's basic operation and ergonomics in the operating room.
To perform a pilot study of the FLARE™ NIR fluorescence imaging system in conjunction with
indocyanine green (ICG) during breast reconstructive surgery utilizing deep inferior
epigastric perforator (DIEP) flaps.
Due to patient-to-patient anatomic variation, the vascular perfusion to the cutaneous
elements in flaps is unpredictable and of great concern to the surgeon planning the design
of the flap. We propose a method of imaging the flap based on the use of invisible
near-infrared fluorescent light that has significant advantages for both patient and
surgeon.
Specific Aims:
A pilot optimization study of the imaging system in combination with ICG to determine
optimal dose, light excitation fluence rate, and camera exposure time.
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Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label
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