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

NCT07635420 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 244

Last updated 2026-06-09

No results posted yet for this study

Summary

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

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

Interventions

DRUG

Indocyanine Green

Indocyanine green (ICG) is administered intravenously during surgery for intraoperative fluorescence angiography assessment of free flap perfusion in head and neck reconstruction. A 25 mg vial of ICG (Verdye®) is reconstituted with sterile water, and approximately 7.5 mg is administered intravenously followed by saline flush. Perfusion is assessed using near-infrared fluorescence imaging systems and SPY-Q quantitative perfusion analysis.

PROCEDURE

Standard clinical perfusion assessment

Standard intraoperative clinical assessment of free flap perfusion including evaluation of flap colour, capillary refill, tissue turgor, bleeding upon needle prick, and Doppler examination as clinically indicated during head and neck free flap reconstruction.

Sponsors & Collaborators

  • Region Skane

    lead OTHER

Principal Investigators

  • Pooya Rajabaleyan, MD, PhD · Region Skåne, Skånes universitetssjukhus, Sektion Plastikkirurgi, Malmö, Sverige

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-01
Primary Completion
2029-01-01
Completion
2029-08-01

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07635420 on ClinicalTrials.gov