Study of ICG Fluorescence Imaging in Open Fracture and Infection Patients

Part of paid clinical trials in Lebanon, New Hampshire.

Sponsor
Dartmouth-Hitchcock Medical Center
Study ID
NCT06793644
Status
Recruiting
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Conditions

  • Fractures, Bone
  • Trauma Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Immunofluorescence Imaging — DRUG
    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.

Study Details

The purpose of this study is to determine whether an indocyanine green (ICG) fluorescence imaging system (cBPI) can be used to provide surgeons with information about bone health or bone blood flow. This will help surgeons better understand the healing potential of bone and relative risk of complication. This is important to help surgeons select the most appropriate treatment for severe traumatic injuries and infections.

Key Dates

Start date
Jun 10, 2025
Status verified
Mar 2026
Primary completion
Oct 31, 2026
Completion
Oct 31, 2027

Study Design

Enrollment
10 participants (estimated)

Arms

  • Arm: Established SSI Fracture Cohort
    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
  • Arm: Open Fracture Cohort
    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.

Primary Outcome Measure

Number of participants who undergo an unplanned fracture-related reoperation [ Time Frame: 12 Months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Dartmouth-Hitchcock Medical CenterLebanonNew Hampshire03756
Ida L Gitajn, MD
[email protected]
603-650-5000

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By research site
Dartmouth-Hitchcock Medical Center· Lebanon, NH

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