ICG Fluorescence Imaging to Guide Head and Neck Free Flap Surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, open-label randomized trial compares intraoperative ICG fluorescence angiography plus standard perfusion assessment to standard clinical assessment alone in adult head and neck free flap reconstruction. Primary outcome is partial flap loss requiring intervention within 30 days post-surgery; secondary outcomes include total flap loss, flap-related re-exploration, flap salvage, and postoperative complications. The study aims to determine if real-time ICG visualization can improve perfusion assessment and reduce complications. Eligible participants are adults undergoing microvascular free flap reconstruction for oncologic, trauma, or benign head and neck defects at Swedish centers. The trial plans to enroll 244 participants across sites led by Region Skane, Skåne University Hospital, Malmö.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Principal investigator: Pooya Rajabaleyan, MD, PhD — Region Skåne, Skånes universitetssjukhus, Sektion Plastikkirurgi, Malmö, Sverige
• Study coordinator: Pooya Rajabaleyan, MD, PhD
• Email: Pooya.r@hotmail.com
• Phone: +4640331000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.