ICG fluorescence imaging to show bone blood flow in open fractures and infections
Prospective Observational Study of ICG Fluorescence Imaging in Open Fracture and Infection Patients: Early Comparison With a Novel Imaging Device
Dartmouth-Hitchcock Medical Center · NCT06793644
This will test whether a dye-based fluorescence camera can show bone blood flow in adults with open fractures or bone infections so surgeons can choose the best treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Dartmouth-Hitchcock Medical Center (other) |
| Locations | 1 site (Lebanon, New Hampshire) |
| Trial ID | NCT06793644 on ClinicalTrials.gov |
What this trial studies
This observational study uses indocyanine green (ICG) fluorescence imaging (cBPI system) during planned surgical care to visualize bone perfusion in adults with open extremity fractures or fracture-related infections. Participants 18 and older who are undergoing external or internal fixation, joint fusion, or debridement will receive the imaging during their routine operative procedures without changing standard treatment. Patients with hand fractures, iodine allergy, or burns at the fracture site are excluded. The goal is to correlate the imaging findings with bone health and healing potential to inform future surgical decision-making.
Who should consider this trial
Good fit: Adults aged 18 or older with open extremity fractures or fracture-related bone infections who are scheduled for surgical fixation, fusion, or debridement and can give informed consent are ideal candidates.
Not a fit: Patients with hand fractures, iodine allergy, burns at the fracture site, or those unable to provide consent — as well as patients not undergoing planned surgical care at the site — are unlikely to benefit from this imaging approach.
Why it matters
Potential benefit: If successful, surgeons could use real-time images of bone blood flow to pick treatments that lower complication risk and improve healing.
How similar studies have performed: ICG fluorescence is well established for soft-tissue perfusion imaging, but its application to bone blood flow is relatively novel and supported mainly by limited pilot and feasibility data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients 18 years of age or older. * Open extremity fracture, planning for management with external fixation, internal fixation or joint fusion. * Fracture Related Infection, planning for management with debridement and possible removal of hardware. * 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. * Burns at the fracture site.
Where this trial is running
Lebanon, New Hampshire
- Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States (RECRUITING)
Study contacts
- Principal investigator: Ida L Gitajn, MD — Dartmouth-Hitchcock Medical Center
- Study coordinator: Jon Mikael Anderson
- Email: jon.mikael.anderson@hitchcock.org
- Phone: 603-653-3306
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Fractures, Bone, Trauma Injury, Immunofluorescence, Orthopaedic Trauma, Infection