Active — Not RecruitingNot Applicable

ICG Fluorescence Imaging in Open Fracture Trauma Patients

United States180 participantsStarted 2020-10-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

Number of participants who undergo an unplanned fracture-related reoperation

Timeframe: 12 months

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

Timeframe: 12 months

Trial details

NCT IDNCT04416412

SponsorDartmouth-Hitchcock Medical Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-01-31

View on ClinicalTrials.gov More Trauma Injury trials