Reconstructive Surgery Clinical Trial
Official title:
Fluorescence Angiography With Fluobeamâ„¢ Camera (Fluoptics Company): Planning and Monitoring of Perforator Flaps
The purpose of this study is to determine whether fluorescence angiography is an effectiveness technique for the localization of vascular perforators and their area of perfusion and for the postoperative monitoring of flap perfusion.
Reconstructive surgery is intended to replace amputated anatomical regions by autologous
tissue taken from distant locations: flaps. The goal is to restitute ad integrum with minimal
sequelae. Among the flaps available, perforator flaps have the advantage of being highly
plastic, large and can be taken from accessory vessels the loss of wich does not compromise
the vitality of the sampling site. However their more variable anatomy requires irradiating
preoperative morphological assessment (CT angiography) or a doppler ultrasonography that is
not always performed by the surgeon himself and does not distinguish between muscle
perforator and skin perforator.
Fluorescence angiography is a superficial exploration technique of vascularization. After
intravenous injection of a tracer (indocyanine green ICG), fluorescence angiography provides
useful surface angiographic imaging in real-time. It can also help in monitoring
intraoperative and postoperative quality of vascular anastomoses. Although fluorescence
angiography has numerous applications (ophthalmology, neurosurgery, liver
transplantation...), its usefulness in surgical flaps is only supported by a few
publications. None really validate its clinical value by comparing it to reference
investigations (CT angiography or doppler ultrasonography).
40 candidate for reconstructive surgery will be included in this study. The day before
surgery, in addition to the usual technique used to locate perforator flaps, the patient will
receive an injection of 0.025 mg / kg Infracyanine® (indocyanine green) and the area of
interest of the flap will be explored with the Fluobeamâ„¢ camera.
Two hours after the surgery, during the usual clinical monitoring of the vitality of the
flap, a new injection of Infracyanine® will test perfusion of the flap by measuring
fluorescence intensity of the target area. These measurement will then be repeated every 6
hours for 4 days.
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