ICG Fluorescence Imaging in Open Fracture Trauma Patients

N/AActive Not RecruitingNCT04416412

Dartmouth-Hitchcock Medical Center180 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

180

Conditions

Trauma Injury

Interventions

Immunofluorescence ImagingOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients 18 years of age or older. 2. Open extremity fracture. 3. Planned definitive fracture management with external fixation, internal fixation, or joint fusion. 4. Open fracture wound management that includes formal surgical debridement within 72 hours of their injury. 5. Will have all planned fracture care surgeries performed by a participating surgeon or delegate. 6. Provision of informed consent. Exclusion Criteria: 1. Inability of patient to provide informed consent 2. Fracture of the hand. 3. Iodine allergy. 4. Received previous surgical debridement or management of their fracture at a non-participating hospital or clinic. 5. Open fracture managed outside of the participating orthopaedic service. 6. Chronic or acute infection at or near the fracture site at the time of initial fracture surgery. 7. Burns at the fracture site.

Locations (4)

University of California, Irvine

Irvine, California, United States

University of Maryland, Baltimore R. Cowley Shock Trauma

Baltimore, Maryland, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Outcomes

Primary Outcomes

Number of participants who undergo an unplanned fracture-related reoperation

All unplanned reoperations will be documented using a specific case report form

Time frame: 12 months

Number of participants who experience a post-procedure surgical site infection

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

Time frame: 12 months

Data from ClinicalTrials.gov

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