NCT07635420RecruitingPhase 4
Comparing Intraoperative Indocyanine Green Fluorescence Imaging With Standard Clinical Assessment for Flap Perfusion in Head and Neck Reconstruction (VISION Trial)
Comparing Intraoperative Indocyanine Green Fluorescence Imaging With Standard Clinical Assessment for Flap Perfusion in Head and Neck Reconstruction: A Randomised Controlled Trial (VISION Trial)
Source: ClinicalTrials.gov · Last updated 29 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 244 (estimated)
- First submitted
- 28 May 2026
- Start date
- 28 Sept 2026
- Primary completion date
- 1 Jan 2029
- Lead sponsor
- Region Skane
- Diseases
- Head and neck cancer
- NCT number
- NCT07635420
- EU CT number
- 2025-524710-29-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 244
- From 28 Sept 2026 to the primary completion date, 1 Jan 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Known allergy to indocyanine green or iodine
- Severe hepatic or renal impairment
Other
- Confirmed or suspected pregnancy
- Breastfeeding
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Region Skane Skanes Universitetssjukhus Coordinator of this site? Confirm its status | Malmo | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.