This is a prospective multicentre randomised controlled trial evaluating whether intraoperative indocyanine green (ICG) fluorescence angiography improves outcomes in head and neck free flap reconstruction compared with standard clinical assessment of flap perfusion. Adult patients undergoing microvascular free flap reconstruction for oncologic, trauma, or benign head and neck defects will be randomised to either intraoperative ICG angiography or conventional clinical perfusion assessment. The primary outcome is partial flap loss requiring intervention within 30 days after surgery. Secondary outcomes include total flap loss, flap-related re-exploration, flap salvage, and postoperative complications.
Age ≥18 years at the time of inclusion
Scheduled to undergo microvascular free flap reconstruction as part of oncologic, trauma, or benign surgery in the head and neck area
Ability to understand study information and provide written informed consent
Known allergy to indocyanine green or iodine
Severe hepatic or renal impairment
Confirmed or suspected pregnancy
Breastfeeding
Parallel
Indocyanine Green
DrugIndocyanine green (ICG) is administered intravenously during surgery for intraoperative fluorescence angiography assessment of free flap perfusion in head and neck reconstruction. A 25 mg vial of ICG (Verdye®) is reconstituted with sterile water, and approximately 7.5 mg is administered intravenously followed by saline flush. Perfusion is assessed using near-infrared fluorescence imaging systems and SPY-Q quantitative perfusion analysis.
Standard clinical perfusion assessment
Procedure/SurgeryStandard intraoperative clinical assessment of free flap perfusion including evaluation of flap colour, capillary refill, tissue turgor, bleeding upon needle prick, and Doppler examination as clinically indicated during head and neck free flap reconstruction.
Partial flap loss requiring intervention
Partial flap loss is defined as clinically evident flap necrosis requiring active therapeutic intervention, including operative debridement/revision in the operating room or bedside debridement/trimming performed by a surgeon beyond routine wound care.
Total flap loss
Complete flap failure requiring flap removal, replacement, or abandonment with documentation of flap non-viability.
Flap-related re-exploration under general anaesthesia
Return to the operating room under general anaesthesia due to suspected or confirmed flap vascular compromise or flap viability concern, excluding planned second-look procedures without concern.
Flap salvage
Successful retention of the index flap following flap-related re-exploration for vascular compromise.
Postoperative complications
Incidence of postoperative complications occurring 90 days after index operation. Predefined surgical complications will be captured systematically and include surgical takeback, partial flap loss, total flap loss, infection, hematoma or bleeding requiring intervention, fistula formation, wound dehiscence, seroma, abnormal wound healing, and other surgical complications. The severity of complications will be classified according to the Clavien-Dindo Classification of Surgical Complications (Grade I-V, where Grade I represents the least severe complication and Grade V represents death).
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