Tissue Oxygenation Measurements During Plastic Surgery Using Spatially Modulated Light (S-FLARE)
This pilot study will enroll three patients who have chosen to proceed with deep inferior
epigastric perforator (DIEP) flap breast reconstruction. This type of reconstruction uses
skin and fat from the abdomen to reconstruct a new breast shape. The construct is
vascularized through perforating arteries and veins that provide a blood supply to this
Current techniques to evaluate vessel selection rely on a handheld Doppler used for
confirmation of blood flow and perfusion; however, this modality is limited as it only
assesses a specific point within the flap.
The S-FLARE imaging system will be used to visualize vascularization in the DIEP flaps, and
this study will compare measurements by the S-FLARE imaging system and the standard-of-care
ViOptix point probe.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Optimization of Ergonomics and Functioning of the S-FLARE Imaging System during Breast Reconstructive Surgery
Due to patient-to-patient anatomic variation, the vascular perfusion to the skin in DIEP flaps is unpredictable and of great concern to the surgeon planning the flap design. We propose a method of imaging tissue oxygenation within a DIEP flap base on the use of invisible near-infrared light. This pilot study is a comparison study of oxygenation measurements taken by the ViOptix optical probe as the standard of care and the S-FLARE imaging system, with the intention of optimizing the ergonomics and functionality of the S-FLARE imaging system for use during breast reconstructive surgery.
10 minute imaging procedure
John V. Frangioni, MD, PhD
Beth Israel Deaconess Medical Center
United States: Institutional Review Board
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