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

NCT07635420 | Not Yet Recruiting Phase 4

• 1 other identifier: 2025-524710-29-00
• Study Type: interventional
• Target: 244
• Locations: 1 country
• Sites: 1

Brief 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

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Total flap loss

  From index surgery to 30 days postoperatively

• Flap-related re-exploration under general anaesthesia

  From index surgery to 30 days postoperatively

• Flap salvage

  From index surgery to 30 days postoperatively

• Postoperative complications

  From index surgery to 90 days postoperatively

• Correlation between intraoperative SPY-Q Relative Perfusion Value (%) and partial flap loss

  From index surgery to 30 days postoperatively

Study Arms (2)

Standard clinical assessment

ACTIVE COMPARATOR

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

Indocyanine Green Fluorescence Angiography

EXPERIMENTAL

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.

Drug: Indocyanine Green; Procedure: Standard clinical perfusion assessment

Interventions

Indocyanine Green DRUG

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.

Also known as: ICG, Verdye

Indocyanine Green Fluorescence Angiography

Standard clinical perfusion assessment PROCEDURE

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.

Indocyanine Green Fluorescence Angiography; Standard clinical assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Known allergy to indocyanine green or iodine
• Severe hepatic or renal impairment
• Confirmed or suspected pregnancy
• Breastfeeding

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

Dept. of Plastic and Reconstructive Surgery and Dept. of Health Sciences, Skåne University Hospital, Malmö, Sweden.

Malmö, Sweden

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Pooya Rajabaleyan, MD, PhD

  Region Skåne, Skånes universitetssjukhus, Sektion Plastikkirurgi, Malmö, Sverige

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pooya Rajabaleyan, MD, PhD

CONTACT

+4640331000; Pooya.r@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective multicentre open-label parallel-group randomised controlled trial comparing intraoperative indocyanine green fluorescence angiography with standard clinical assessment for flap perfusion in head and neck free flap reconstruction.

Study Record Dates

• First Submitted: May 28, 2026
• First Posted: June 9, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: June 9, 2026

Record last verified: 2026-05

Locations

SE (1)