Study of ICG Fluorescence Imaging in Open Fracture and Infection Patients (cBPI)

Prospective Observational Study of ICG Fluorescence Imaging in Open Fracture and Infection Patients: Early Comparison With a Novel Imaging Device

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.

Study Overview

• Status: Recruiting
• Conditions: Fractures, Bone; Trauma Injury
• Intervention / Treatment: Drug: Immunofluorescence Imaging

• Study Type: Observational
• Enrollment (Estimated): 10

Contacts and Locations

• Study Contact: Name: Ida L Gitajn, MD; Phone Number: 603-650-5000; Email: ida.l.gitajn@hitchcock.org
• Study Contact Backup: Name: Jon Mikael Anderson; Phone Number: 603-653-3306; Email: jon.mikael.anderson@hitchcock.org

Study Locations

• United States
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Recruiting
      • Dartmouth-Hitchcock Medical Center
      • Contact: Ida L Gitajn, MD; Phone Number: 603-650-5000; Email: ida.l.gitajn@hitchcock.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborators: Dartmouth College
• Investigators: Principal Investigator: Ida L Gitajn, MD, Dartmouth-Hitchcock Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: January 21, 2025
• First Submitted That Met QC Criteria: January 21, 2025
• First Posted (Actual): January 27, 2025

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Infection; Immunofluorescence; Orthopaedic Trauma
• Additional Relevant MeSH Terms: Wounds and Injuries; Accidental Injuries; Fractures, Bone; Infections
• Other Study ID Numbers: STUDY02002551

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No