Study of ICG Fluorescence Imaging in Open Fracture and Infection Patients

NCT06793644 | Recruiting

• 1 other identifier: STUDY02002551
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

Immunofluorescence; Orthopaedic Trauma; Infection

Outcome Measures

Primary Outcomes (2)

• Number of participants who undergo an unplanned fracture-related reoperation

  All unplanned reoperations will be documented using a specific case report form

  12 Months

• Number of participants who experience a post-procedure surgical site infection

  Post-procedure surgical site infection using Centers for Disease Control criteria will be documented at each follow-up

  12 Months

Study Arms (2)

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

Drug: Immunofluorescence Imaging

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.

Drug: Immunofluorescence Imaging

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.

Established SSI Fracture Cohort; Open Fracture Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients 18 years of age or older who present with an open fracture or fracture related infection.

You may qualify if:

• 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.

You may not qualify if:

• Inability of patient to provide informed consent
• Fracture of the hand.
• Iodine allergy.
• Burns at the fracture site.

Sponsors & Collaborators

• Dartmouth College: collaborator
• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

RECRUITING

MeSH Terms

Conditions

Fractures, Bone; Accidental Injuries; Infections

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Ida L Gitajn, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jon Mikael Anderson

CONTACT

603-653-3306; jon.mikael.anderson@hitchcock.org

Ida L Gitajn, MD

CONTACT

603-650-5000; ida.l.gitajn@hitchcock.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Section Chief Orthopaedics

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: January 27, 2025
• Study Start: June 10, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)