ICG Fluorescence Imaging in Post-traumatic Infection
United States104 participantsStarted 2020-09-14
Plain-language summary
The focus of this prospective observational study is to (1) establish the range and variation associated with bone/soft tissue perfusion in fracture patients, using ICG fluorescence imaging; (2) examine the relationship between perfusion and complications such as surgical site infection (SSI), persistent SSI, and fracture nonunion; (3) to determine whether the quantitative ICG fluorescence can be used to guide bony debridement in the setting of infected fracture to minimize complications.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients 18 years of age or older.
✓. Extremity fracture.
✓. Prior definitive fracture management with external fixation, internal fixation, or joint fusion.
✓. Superficial, deep, or organ space SSI (as per CDC criteria) at the fracture site that requires operative management.
✓. Will have all fracture care surgeries performed by a participating surgeon or delegate.
✓. Provision of informed consent.
✓. Patients 18 years of age or older.
✓. Closed extremity fracture.
Exclusion criteria
✕. Fracture of the hand.
✕. Iodine allergy.
✕. Received previous surgical debridement to manage the SSI.
✕. Incarceration.
✕. Problems, in the judgment of study personnel, with maintaining follow-up with the patient.
✕. the presence of an electronic implant, such as a pacemaker
✕. the presence of a metal implant, such as an aneurysm clip
What they're measuring
1
Number of patients experiencing post procedure surgical site infections
Timeframe: 1 year
2
Number of patients requiring unplanned fracture-related reoperations