Comparing intraoperative indocyanine green fluorescence imaging with standard clinical assessment for flap perfusion in head and neck reconstruction: A randomised controlled Trial (VISION Trial)

INTERVENTION: Product Name: Verdye 5 mg/ml pulver till injektionsvätska, lösning, Product Code:PRD10910178, Pharmaceutical Form: SOLUTION FOR INJECTION, Other descriptive name: , Strength: CONDITION: Head and neck cancer Therapeutic area: Diseases [C] ‐ Neoplasms [C04] Therapeutic area: Diseases [C] ‐ Otorhinolaryngologic Diseases [C09] Therapeutic area: Diseases [C] ‐ Skin and Connective Tissue Diseases [C17] PRIMARY OUTCOME: Main Objective: The primary objective is to compare the incidence of partial flap loss requiring surgical intervention within 1 month between patients undergoing intraoperative ICG angiography and those assessed using standard clinical methods. Primary end point(s): The primary endpoint is incidence of partial flap loss requiring surgical intervention within 1 month. Secondary Objective: Flap loss within one month., Flap related re‐exploration rate in general anaesthesia within one month., Flap salvage rate within one month., Postoperative complications (graded according to the Clavien‐Dindo classification) within three months., Association between intraoperative SPY‐Q perfusion values and partial flap loss within 30 days, assessed using quantitative perfusion measurements derived from intraoperative indocyanine green fluorescence angiography. SECONDARY OUTCOME: Secondary end point(s):The secondary endpoints of this trial are total flap loss, flap related re‐exploration rate in general anaesthesia and flap salvage rate within one month, and postoperative complications (graded according to the Clavien‐Dindo classification) within three months. INCLUSION CRITERIA: To be included in the trial, subjects must meet all of the following criteria: 1) The subject is able to provide informed consent to the trial. 2) The subject is above 18 years of age. 3) The subject will undergo microvascular free flap reconstruction for oncologic or traumatic head and neck defects.