RecruitingNCT06793644

Study of ICG Fluorescence Imaging in Open Fracture and Infection Patients

Prospective Observational Study of ICG Fluorescence Imaging in Open Fracture and Infection Patients: Early Comparison With a Novel Imaging Device

Sponsor

Dartmouth-Hitchcock Medical Center

Enrollment

10 participants

Start Date

Jun 10, 2025

Study Type

OBSERVATIONAL

Conditions

Fractures, Bone Trauma Injury

Summary

The purpose of this study is to determine whether an indocyanine green (ICG) fluorescence imaging system (cBPI) can be used to provide surgeons with information about bone health or bone blood flow. This will help surgeons better understand the healing potential of bone and relative risk of complication. This is important to help surgeons select the most appropriate treatment for severe traumatic injuries and infections.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

Patients 18 years of age or older.
Open extremity fracture, planning for management with external fixation, internal fixation or joint fusion.
Fracture Related Infection, planning for management with debridement and possible removal of hardware.
Will have all planned fracture care surgeries performed by a participating surgeon or delegate.
Provision of informed consent.

Exclusion Criteria4

Inability of patient to provide informed consent
Fracture of the hand.
Iodine allergy.
Burns at the fracture site.

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Interventions

DRUGImmunofluorescence Imaging

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.