ICG Fluorescence Imaging in Open Fracture Trauma Patients

Optimizing Surgical Debridement Following High-energy Open Trauma With Dynamic Contrast-enhanced Fluorescence Imaging

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.

Study Overview

• Status: Recruiting
• Conditions: Trauma Injury
• Intervention / Treatment: Other: Immunofluorescence Imaging

Detailed Description

This is a prospective observational study that will evaluate the association between bone and tissue perfusion, as measured using indocyanine green (ICG) fluorescence imaging, and complications. This will be used to develop ICG fluorescence imaging as a diagnostic tool to objectively and quantitatively guide operative debridement. The study population includes all open fracture patients regardless of race, ethnicity, or sex/gender. Primary outcome measure is all-cause re-operation and secondary outcome measure is surgical site infection. All patients will be followed for a total of 12 months.

• Study Type: Observational
• Enrollment (Estimated): 180

Contacts and Locations

• Study Contact: Name: Jon Mikael Anderson; Phone Number: 603-653-3306; Email: jon.mikael.anderson@hitchcock.org

Study Locations

• United States
  • California
    • Irvine, California, United States, 92614
      • Recruiting
      • University of California, Irvine
      • Contact: Susan Demas; Phone Number: 714-456-7710; Email: sdemas@hs.uci.edu
      • Principal Investigator: John Scolaro
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Recruiting
      • University of Maryland, Baltimore R. Cowley Shock Trauma
      • Contact: Heather Phipps; Phone Number: 410-706-7180; Email: hphipps@som.umaryland.edu
      • Principal Investigator: Gerard Slobogean, MD
  • Massachusetts
    • Boston, Massachusetts, United States, 021115
      • Completed
      • Brigham and Women's Hospital
  • 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
      • Contact: Jon Mikael Anderson; Phone Number: 603-653-3306; Email: jon.mikael.anderson@hitchcock.org
      • Principal Investigator: Ida L. Gitajn, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (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 will be considered for the open fracture cohort.

Description

Inclusion Criteria:

1. Patients 18 years of age or older.
2. Open extremity fracture.
3. Planned definitive fracture management with external fixation, internal fixation, or joint fusion.
4. Open fracture wound management that includes formal surgical debridement within 72 hours of their injury.
5. Will have all planned fracture care surgeries performed by a participating surgeon or delegate.
6. Provision of informed consent.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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: University of Maryland, Baltimore; United States Department of Defense; Brigham and Women's Hospital; University of California, Irvine; Dartmouth College
• Investigators: Principal Investigator: Ida L Gitajn, MD, Dartmouth-Hitchcock Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Estimated): January 31, 2025
• Study Completion (Estimated): January 31, 2026

Study Registration Dates

• First Submitted: May 21, 2020
• First Submitted That Met QC Criteria: June 3, 2020
• First Posted (Actual): June 4, 2020

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Trauma; Open Fracture; Immunofluorescence; Orthopaedic
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: D20058; OR190062 (Other Grant/Funding Number: Department of Defense)

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