ICG Fluorescence Imaging in Open Fracture Trauma Patients

This is a prospective observational study that will evaluate the association between bone and tissue perfusion, as measured by indocyanine green (ICG) fluorescence imaging, and complications, in an effort to develop ICG fluorescence imaging as a diagnostic tool to quantitatively guide operative debridement.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Trauma Injury Accidental Injuries Fractures, Bone Fractures, Open Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California, Irvine, Irvine, California, United States

About this study

This is a prospective observational study that will evaluate the association between bone and tissue perfusion, as measured using indocyanine green (ICG) fluorescence imaging, and complications. This will be used to develop ICG fluorescence imaging as a diagnostic tool to objectively and quantitatively guide operative debridement. The study population includes all open fracture patients regardless of race, ethnicity, or sex/gender. Primary outcome measure is all-cause re-operation and secondary outcome measure is surgical site infection. All patients will be followed for a total of 12 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients 18 years of age or older.
Open extremity fracture.
Planned definitive fracture management with external fixation, internal fixation, or joint fusion.
Open fracture wound management that includes formal surgical debridement within 72 hours of their injury.
Will have all planned fracture care surgeries performed by a participating surgeon or delegate.
Provision of informed consent.

Exclusion criteria

Inability of patient to provide informed consent
Fracture of the hand.
Iodine allergy.
Received previous surgical debridement or management of their fracture at a non-participating hospital or clinic.
Open fracture managed outside of the participating orthopaedic service.
Chronic or acute infection at or near the fracture site at the time of initial fracture surgery.
Burns at the fracture site.

Treatment and study plan

Immunofluorescence Imaging

Other

Patients will be administered FDA approved ICG through intravenous injection and imaged by a FDA approved surgical microscope (Spy Elite) which is 0.5 meter away from the subject. Both ICG fluorescence and the two imaging systems have been used for routine clinical practice for many years. Figure (a) shows the Schematic sketch of the imaging systems. ICG fluorescence imaging utilizes intravenously injected ICG, which is a fluorescent dye that is FDA-approved for clinical use, illuminated with near-infrared light. The ICG dye is indirectly activated and the dynamic fluorescence due to bone perfusion can be captured by a video rate imaging system.

Primary outcomes

Number of participants who undergo an unplanned fracture-related reoperation

Time frame: 12 months

All unplanned reoperations will be documented using a specific case report form
Number of participants who experience a post-procedure surgical site infection

Time frame: 12 months

Post-procedure surgical site infection using Centers for Disease Control criteria will be documented at each follow-up

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Collaborators

Brigham and Women's Hospital
Dartmouth College
United States Department of Defense
University of California, Irvine
University of Maryland, Baltimore

Registry information

Official study title

Optimizing Surgical Debridement Following High-energy Open Trauma With Dynamic Contrast-enhanced Fluorescence Imaging

Important dates

Study start: 2020
Primary completion: 2026
Study completion: 2026
First posted: Jun 4, 2020
Registry last updated: May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting