Comparing Intraoperative Indocyanine Green Fluorescence Imaging With Standard Clinical Assessment for Flap Perfusion in Head and Neck Reconstruction (VISION Trial)

The VISION Trial is a prospective, multicentre, open‐label, parallel‐group randomisedcontrolled trial comparing intraoperative indocyanine green (ICG) fluorescenceangiography with standard clinical assessment for flap perfusion in head and neck freeflap reconstruction.Free flap reconstruction is an essential component of complex head and neckreconstruction, but flap survival depends on adequate microvascular perfusion.Conventional intraoperative assessment methods, including inspection of flap colour,capillary refill, tissue turgor, bleeding upon needle prick, and Doppler examination,provide indirect assessment of perfusion and may be unreliable in some situations.ICG fluorescence angiography enables real‐time visualisation of arterial inflow andvenous outflow using near‐infrared fluorescence imaging. Retrospective studies havesuggested that ICG angiography may reduce rates of partial flap loss and flap‐relatedre‐exploration, but high‐quality prospective randomised evidence remains limited.A total of 244 adult patients undergoing microvascular free flap reconstruction foroncologic, trauma, or benign head and neck defects at participating Swedish centres willbe included. Participants will be randomised to either standard clinical assessment aloneor standard clinical assessment supplemented with intraoperative ICG fluorescenceangiography.In the intervention group, ICG angiography will be performed intraoperatively usingnear‐infrared fluorescence imaging systems after administration of intravenousindocyanine green (Verdye®). Quantitative perfusion analysis will also be performed usingSPY‐Q software.The primary endpoint is partial flap loss requiring intervention within 30 days aftersurgery. Secondary endpoints include total flap loss, flap‐related re‐exploration undergeneral anaesthesia, flap salvage, postoperative complications graded according toClavien‐Dindo classification, and the association between intraoperative SPY‐Q perfusionvalues and flap outcomes.No additional trial‐specific postoperative visits are required. Outcomes will be assessedthrough structured chart review at 30 and 90 days postoperatively.