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NCT Number: NCT06793644

Study of ICG Fluorescence Imaging in Open Fracture and Infection Patients

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.

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Key information

Conditions

Fractures, Bone Accidental Injuries Infections Trauma Injury Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location status: Recruiting

Location contact

Ida L Gitajn, MD

CONTACT

[email protected]

603-650-5000

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Number of participants who undergo an unplanned fracture-related reoperation

    Time frame: 12 Months

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

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

    Time frame: 12 Months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Ida L Gitajn, MD

CONTACT

[email protected]

603-650-5000

Jon Mikael Anderson

CONTACT

[email protected]

603-653-3306

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Collaborators

  • Dartmouth College

Registry information

Official study title

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

Acronym: cBPI

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jan 27, 2025
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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