Clinical trial · Interventional
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
- Retrieved
- Sep 30, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260930-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Free Flap | — | UNRESOLVED | — |
| Free Flap Evaluation | — | UNRESOLVED | — |
| Free Tissue Flaps | — | UNRESOLVED | — |
| Head and Neck Cancer (H&N) | Malignant Head and Neck Neoplasm | ALIAS | 0.85 |
| Indocyanine Green | — | UNRESOLVED | — |
| Indocyanine Green (ICG) | — | UNRESOLVED | — |
| Microsurgery | — | UNRESOLVED | — |
| Randomised Controlled Trial | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Indocyanine Green | Drug | — | UNRESOLVED |
| Standard clinical perfusion assessment | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard clinical assessment
- description
- Participants undergo intraoperative assessment of free flap perfusion using standard clinical assessment methods, including inspection of flap colour, capillary refill, tissue turgor, bleeding upon needle prick, and Doppler examination as clinically indicated. Surgical revision is performed according to standard clinical practice if inadequate perfusion is suspected.
- interventionNames
- Procedure: Standard clinical perfusion assessment
- type
- EXPERIMENTAL
- label
- Indocyanine Green Fluorescence Angiography
- description
- Participants undergo intraoperative assessment of free flap perfusion using indocyanine green (ICG) fluorescence angiography in addition to standard clinical assessment. ICG is administered intravenously and perfusion is evaluated using near-infrared fluorescence imaging and SPY-Q quantitative perfusion analysis during head and neck free flap reconstruction.
- interventionNames
- Drug: Indocyanine Green
- Procedure: Standard clinical perfusion assessment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available