Recruiting

ICG Fluorescence Imaging

Sponsor:

Dartmouth-Hitchcock Medical Center

Code:

NCT06793644

Conditions

Fractures, Bone

Trauma Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Immunofluorescence Imaging

Study Details

Brief summary:

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.

Conditions

Fractures, Bone

Trauma Injury

Study ID

NCT06793644

Start date

Jun 10, 2025

Status verified date

Mar, 2026

Completion date

Oct, 2027

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

10 participants

Anticipated

Interventions and Outcome Measures

Arms

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

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.

Interventions

Immunofluorescence Imaging

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.

Primary outcome measure

  • Number of participants who undergo an unplanned fracture-related reoperation [ Time Frame: 12 Months ]
  • Number of participants who experience a post-procedure surgical site infection [ Time Frame: 12 Months ]

Central Contacts and Locations

Locations

Dartmouth-Hitchcock Medical Center

Recruiting

Lebanon, New Hampshire, United States, 03756

Contacts

More Information

Sponsor

Dartmouth-Hitchcock Medical Center

Last update posted

Mar 19, 2026

Last verified

Mar, 2026

Keywords

  • Immunofluorescence
  • Orthopaedic Trauma
  • Infection

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dartmouth-Hitchcock Medical Center on 2026-03-19.