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ACTIVE NOT RECRUITING
NCT04416412

ICG Fluorescence Imaging in Open Fracture Trauma Patients

Sponsor: Dartmouth-Hitchcock Medical Center

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

180

Start Date

2020-10-01

Completion Date

2026-01-31

Last Updated

2025-05-01

Healthy Volunteers

No

Conditions

Interventions

OTHER

Immunofluorescence 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.

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