ICG Fluorescence Imaging in Open Fracture Trauma Patients

NCT04416412 | Active Not Recruiting DMC

• 2 other identifiers: D20058OR190062
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 4

Brief Summary

This is a prospective observational study that will evaluate the association between bone and tissue perfusion, as measured by indocyanine green (ICG) fluorescence imaging, and complications, in an effort to develop ICG fluorescence imaging as a diagnostic tool to quantitatively guide operative debridement.

Conditions

Trauma Injury

Keywords

Immunofluorescence; Orthopaedic; Trauma; Open Fracture

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 (1)

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.

Other: Immunofluorescence Imaging

Interventions

Immunofluorescence Imaging OTHER

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

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 will be considered for the open fracture cohort.

You may qualify if:

• 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.

You may not qualify if:

• Inability of patient to provide informed consent
• Fracture of the hand.
• Iodine allergy.
• Received previous surgical debridement or management of their fracture at a non-participating hospital or clinic.
• Open fracture managed outside of the participating orthopaedic service.
• Chronic or acute infection at or near the fracture site at the time of initial fracture surgery.
• Burns at the fracture site.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• Dartmouth College: collaborator
• United States Department of Defense: collaborator
• Brigham and Women's Hospital: collaborator
• University of California, Irvine: collaborator
• University of Maryland, Baltimore: collaborator

Study Sites (4)

University of California, Irvine

Irvine, California, 92614, United States

Location

University of Maryland, Baltimore R. Cowley Shock Trauma

Baltimore, Maryland, 21201, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 021115, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Accidental Injuries; Wounds and Injuries; Fractures, Open

Condition Hierarchy (Ancestors)

Fractures, Bone

Study Officials

• Ida L Gitajn, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: May 21, 2020
• First Posted: June 4, 2020
• Study Start: October 1, 2020
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: May 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)