ICG-POST

Indocyanine Green Fluorescence Angiography for Microvascular Free Flap Monitoring in Head and Neck Reconstruction - ICG-POST

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON58066

Enrollment

Registered

2025-05-21

Start date

2025-11-01

Completion date

Unknown

Last updated

2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Free Flap Thrombosis Free Flap Necrosis Free Flap Compromise Free Flap Ischaemia Free Flap Ischemia Free Flap Congestion Microvascular Free Flap Thrombosis Microvascular Free Flap Necrosis Microvascular Free Flap Compromise Microvascular Free Flap Ischaemia Microvascular Free Flap Ischemia Microvascular Free Flap Congestion Free Microvascular Flap Thrombosis Free Microvascular Flap Necrosis Free Microvascular Flap Compromise Free Microvascular Flap Ischaemia Free Microvascular Flap Ischemia Free

Interventions

First, in ten patients, iterative intra- and postoperative ICG-FA measurements will be performed to obtain reference data.&nbsp

Then, in sixty patients, ICG-FA measurements will be performed once intraoperative, and in case of doubt about the perfusion of the microvascular free flap based on the clinical examination.&nbsp

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: The patient has provided written informed consent before participating in the study. The patient has an oncologic defect and will receive a reconstruction with a microvascular free flap in the head and neck region. The patient is =18 years of age at the time of consent. 

Exclusion criteria

Exclusion criteria: The patient is incapacitated. The patient has had a previous allergic reaction after administration of ICG or iodine.  The patient is pregnant. The patient will have a buried microvascular free flap. The patient is diagnosed with hyperthyroidism or with autonomic thyroid adenomas. The patient is diagnosed with severe renal insufficiency, defined as eGFR <30 mL/min. 

Design outcomes

Primary

Measure	Time frame
The joint use of clinical examination and ICG-FA will be evaluated: sensitivity, specificity and total accuracy to diagnose compromised patency of the free microvascular flaps.  The findings of the clinical examination and ICG-FA parameters of compromised flaps will be compared to 1) the parameters of other non-compromised flaps and 2) the parameters of the intra-operative ICG-FA measurement of the same flap.	—

Measure

Time frame

The joint use of clinical examination and ICG-FA will be evaluated: sensitivity, specificity and total accuracy to diagnose compromised patency of the free microvascular flaps.  The findings of the clinical examination and ICG-FA parameters of compromised flaps will be compared to 1) the parameters of other non-compromised flaps and 2) the parameters of the intra-operative ICG-FA measurement of the same flap. 

—

Secondary

Measure	Time frame
The diagnostic accuracy of the various ICG-FA parameters, as collected via the Stryker software, will be assessed.	—

Countries

Netherlands

Contacts

Public ContactR. Bree

Universitair Medisch Centrum Utrecht

e.kruimer@umcutrecht.nl31 88 75 508 19

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)