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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Free Tissue Flaps; Indocyanine Green; Microsurgery; Indocyanine Green (ICG); Free Flap; Randomised Controlled Trial; Free Flap Evaluation; Head and Neck Cancer (H&N)
• Intervention / Treatment: Procedure: Standard clinical perfusion assessment; Drug: Indocyanine Green

Detailed Description

The VISION Trial is a prospective, multicentre, open-label, parallel-group randomised controlled trial comparing intraoperative indocyanine green (ICG) fluorescence angiography with standard clinical assessment for flap perfusion in head and neck free flap reconstruction.

Free flap reconstruction is an essential component of complex head and neck reconstruction, but flap survival depends on adequate microvascular perfusion. Conventional intraoperative assessment methods, including inspection of flap colour, capillary refill, tissue turgor, bleeding upon needle prick, and Doppler examination, provide indirect assessment of perfusion and may be unreliable in some situations.

ICG fluorescence angiography enables real-time visualisation of arterial inflow and venous outflow using near-infrared fluorescence imaging. Retrospective studies have suggested that ICG angiography may reduce rates of partial flap loss and flap-related re-exploration, but high-quality prospective randomised evidence remains limited.

A total of 244 adult patients undergoing microvascular free flap reconstruction for oncologic, trauma, or benign head and neck defects at participating Swedish centres will be included. Participants will be randomised to either standard clinical assessment alone or standard clinical assessment supplemented with intraoperative ICG fluorescence angiography.

In the intervention group, ICG angiography will be performed intraoperatively using near-infrared fluorescence imaging systems after administration of intravenous indocyanine green (Verdye®). Quantitative perfusion analysis will also be performed using SPY-Q software.

The primary endpoint is partial flap loss requiring intervention within 30 days after surgery. Secondary endpoints include total flap loss, flap-related re-exploration under general anaesthesia, flap salvage, postoperative complications graded according to Clavien-Dindo classification, and the association between intraoperative SPY-Q perfusion values and flap outcomes.

No additional trial-specific postoperative visits are required. Outcomes will be assessed through structured chart review at 30 and 90 days postoperatively.

• Study Type: Interventional
• Enrollment (Estimated): 244
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Pooya Rajabaleyan, MD, PhD; Phone Number: +4640331000; Email: Pooya.r@hotmail.com

Study Locations

• Sweden
  • Malmö, Sweden
    • Dept. of Plastic and Reconstructive Surgery and Dept. of Health Sciences, Skåne University Hospital, Malmö, Sweden.
    • Contact: Pooya Rajabaleyan, MD, PhD; Phone Number: +4640331000; Email: Pooya.r@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard clinical assessment; 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.	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.
Experimental: Indocyanine Green Fluorescence Angiography; 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.	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.; 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.; Other Names: ICG; Verdye

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Partial flap loss requiring intervention	Partial flap loss is defined as clinically evident flap necrosis requiring active therapeutic intervention, including operative debridement/revision in the operating room or bedside debridement/trimming performed by a surgeon beyond routine wound care.	From index surgery to 30 days postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total flap loss	Complete flap failure requiring flap removal, replacement, or abandonment with documentation of flap non-viability.	From index surgery to 30 days postoperatively
Flap-related re-exploration under general anaesthesia	Return to the operating room under general anaesthesia due to suspected or confirmed flap vascular compromise or flap viability concern, excluding planned second-look procedures without concern.	From index surgery to 30 days postoperatively
Flap salvage	Successful retention of the index flap following flap-related re-exploration for vascular compromise.	From index surgery to 30 days postoperatively
Postoperative complications	Incidence of postoperative complications occurring 90 days after index operation. Predefined surgical complications will be captured systematically and include surgical takeback, partial flap loss, total flap loss, infection, hematoma or bleeding requiring intervention, fistula formation, wound dehiscence, seroma, abnormal wound healing, and other surgical complications. The severity of complications will be classified according to the Clavien-Dindo Classification of Surgical Complications (Grade I-V, where Grade I represents the least severe complication and Grade V represents death).	From index surgery to 90 days postoperatively
Correlation between intraoperative SPY-Q Relative Perfusion Value (%) and partial flap loss	Correlation between intraoperative tissue perfusion measured using SPY-Q quantitative analysis software following indocyanine green fluorescence angiography and postoperative partial flap loss within 30 days after surgery. SPY-Q Relative Perfusion Value is reported as a percentage ranging from 0% to 100%, where higher values indicate greater tissue perfusion. Partial flap loss is assessed clinically and recorded as a binary outcome (present or absent). The outcome measure is the correlation coefficient between SPY-Q Relative Perfusion Value and partial flap loss.	From index surgery to 30 days postoperatively

Collaborators and Investigators

• Sponsor: Region Skane
• Investigators: Principal Investigator: Pooya Rajabaleyan, MD, PhD, Region Skåne, Skånes universitetssjukhus, Sektion Plastikkirurgi, Malmö, Sverige

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): August 1, 2029

Study Registration Dates

• First Submitted: May 28, 2026
• First Submitted That Met QC Criteria: June 8, 2026
• First Posted (Actual): June 9, 2026

Study Record Updates

• Last Update Posted (Actual): June 9, 2026
• Last Update Submitted That Met QC Criteria: June 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indoles; Indocyanine Green
• Other Study ID Numbers: 2025-524710-29-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No