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

RecruitingPhase 4Ages 18 Years - anyAllRegion Skane
NCT07635420 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * Known allergy to indocyanine green or iodine * Severe hepatic or renal impairment * Confirmed or suspected pregnancy * Breastfeeding
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What it tests

  • Indocyanine Green
  • Standard clinical perfusion assessment
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Where

1 site
Dept. of Plastic and Reconstructive Surgery and Dept. of Health Sciences, Skåne University Hospital, Malmö, Sweden.
Malmö, Sweden
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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