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

Starting soon · Phase 4

Conditions studied: Head and Neck Cancer (H&N), Free Tissue Flaps, Free Flap, Free Flap Evaluation, Indocyanine Green, Indocyanine Green (ICG), Microsurgery, Randomised Controlled Trial

In brief

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.

Key facts

Study ID

NCT07635420

Run by

Region Skane

People needed

244

Starts

2026-10-01

Expected to finish

2029-08-01

Last updated by the study team

2026-06-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Known allergy to indocyanine green or iodine
• Severe hepatic or renal impairment
• Confirmed or suspected pregnancy
• Breastfeeding

Where it is running

• Dept. of Plastic and Reconstructive Surgery and Dept. of Health Sciences, Skåne University Hospital, Malmö, Sweden. — Malmö, Sweden

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.