ICG Fluorescence Imaging in Post-traumatic Infection

Completed

Conditions studied: Trauma Injury

In brief

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.

Key facts

Study ID

NCT04403204

Run by

Dartmouth-Hitchcock Medical Center

People needed

104

Starts

2020-09-14

Expected to finish

2025-10-08

Last updated by the study team

2026-02-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Established SSI Fracture (Cohort Cohort 1, Group 1)
• 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.
• Subset: DCE-MRI (Cohort 1-1, Group 2)
• Patients 18 years of age or older.
• Closed extremity fracture.
• Planned definitive fracture management with external fixation, internal fixation, or joint fusion.
• Will have all planned fracture care surgeries performed by a participating surgeon or delegate.
• Provision of informed consent.

You may not qualify if…

• Established SSI Fracture Cohort (Cohort 1, Group 1)
• 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.
• Subset: DCE-MRI (Cohort 1-1, Group2)
• the presence of an electronic implant, such as a pacemaker
• the presence of a metal implant, such as an aneurysm clip
• the presence of other contraindication(s), as determined by the MRI technologists and radiologists.
• A history of allergy to iodides
• A GFR < 30 ml/min as determined by blood test on the day of NIR/MR imaging, or from lab results within 3 months of DCE-MRI for this study

Where it is running

• University of California, Irvine — Irvine, California, United States
• University of Maryland, Baltimore R. Adams 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

Full record on ClinicalTrials.gov

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