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

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.

NCT Number	NCT07635420
Lead Sponsor	Region Skane
Conditions	Head and Neck Cancer (H&N), Free Tissue Flaps, Free Flap, Free Flap Evaluation, Indocyanine Green, Indocyanine Green (ICG), Microsurgery, Randomised Controlled Trial
Enrollment	244 participants
Start Date	2026-10-01
Primary Completion	2029-01-01 (estimated)
Study Completion	2029-08-01 (estimated)
Updated on ClinicalTrials.gov	2026-06-09