ICG Fluorescence Imaging in Post-traumatic Infecton

Overview

The focus of this prospective observational study is to (1) establish the range and variation associated with bone/soft tissue perfusion in fracture patients, using ICG fluorescence imaging; (2) examine the relationship between perfusion and complications such as surgical site infection (SSI), persistent SSI, and fracture nonunion; (3) to determine whether the quantitative ICG fluorescence can be used to guide bony debridement in the setting of infected fracture to minimize complications.

Full Title of Study: “Real-time Fluorescence-based Measurement of Bone Perfusion in Post-traumatic Infection”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: May 31, 2024

Detailed Description

This will be a prospective observational trial to better understand the range and variation associated with bone/soft tissue perfusion in fracture patients and examine the relationship between perfusion, measured using quantitative Indocyanine green (ICG) fluorescence and complications such as surgical site infection (SSI), persistent SSI, and fracture nonunion. Primary outcome measure is complication (either infection, recurrent infection or nonunion).

Eligible consenting patients will receive standard of care treatment for their fracture or infection including irrigation and debridement of their operative site and/or fracture fixation. After exposure, 0.1 mg/Kg ICG will be injected intravenously and video rate ICG fluorescence images will be acquired 20 seconds before and 4 minutes after the injection, each before and after debridement.

A subset of 30post-fracture complication patients will undergo surgical treatment for their infection in Center of Innovation Surgery (CIS) and have either an intraoperative Dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) after exposure but before the ICG injection or a preoperative DCE-MRI. Patients receiving surgery in the CIS will be required to sign an additional CIS-specific consent document. The need for repeat surgical procedure will be left up to the treating surgeon. If repeat procedure is needed, pre- and post-debridement quantitative ICG fluorescence images will be obtained at each procedure.

Study participants will be followed at 2 weeks, 6 weeks, 3 months, 6 months, and one year from their index study surgery. Complication including index infection, recurrent infection or delaying union/nonunion will be identified at the time of diagnosis and/or during each participants assessment that occurs during routine outpatient clinic visit. Detailed information on the infection including date of diagnosis, participant signs and symptoms, culture test results, methodof treatment(s), and date of resolution will be documented.

Interventions

  • Other: Immunofluorescence Imaging
    • Patients will be administered FDA approved ICG through intravenous injection and imaged by a FDA approved surgical microscope (Pentero or 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.
  • Other: DCE-MRI
    • Characterize the relationship between bone perfusion as quantified by ICG based DCE-FI and DCE-MRI in human patients to develop an accurate depth-sensitive fluorescence imaging model that will correct for the surface-weighted feature of fluorescence imaging

Arms, Groups and Cohorts

  • 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
  • Closed Fracture Cohort
    • Patients 18 years of age or older Closed extremity fracture Planned definitive fracture management with external fixation, internal fixation, or joint fusion. Provision of informed consent
  • Established SSI Fracture Cohort Subset (DCE-MRI)
    • 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

Clinical Trial Outcome Measures

Primary Measures

  • Number of patients experiencing post procedure surgical site infections
    • Time Frame: 1 year
    • Post-procedure surgical site infection using CDC criteria will be documented at each follow-up appointment up to one year
  • Number of patients requiring unplanned fracture-related reoperations
    • Time Frame: 1 year
    • All unplanned reoperations will be documented

Participating in This Clinical Trial

Inclusion Criteria

Established SSI Fracture Cohort Cohort 1)

1. Patients 18 years of age or older.

2. Extremity fracture.

3. Prior definitive fracture management with external fixation, internal fixation, or joint fusion.

4. Superficial, deep, or organ space SSI (as per CDC criteria) at the fracture site that requires operative management.

5. Will have all fracture care surgeries performed by a participating surgeon or delegate.

6. Provision of informed consent.

Subset: DCE-MRI (Cohort 1-1)

1. Patients 18 years of age or older.

2. Closed extremity fracture.

3. Planned definitive fracture management with external fixation, internal fixation, or joint fusion.

4. Will have all planned fracture care surgeries performed by a participating surgeon or delegate.

5. Provision of informed consent.

Closed Fracture Cohort (Cohort 2)

1. Patients 18 years of age or older.

2. Closed extremity fracture.

3. Planned definitive fracture management with external fixation, internal fixation, or joint fusion.

4. Will have all planned fracture care surgeries performed by a participating surgeon or delegate.

5. Provision of informed consent.

Exclusion Criteria

Established SSI Fracture Cohort (Cohort 1)

1. Fracture of the hand.

2. Iodine allergy.

3. Received previous surgical debridement to manage the SSI.

4. Incarceration.

5. Problems, in the judgment of study personnel, with maintaining follow-up with the patient.

Subset: DCE-MRI (Cohort 1-1)

6. the presence of an electronic implant, such as a pacemaker

7. the presence of a metal implant, such as an aneurysm clip

8. the presence of other contraindication(s), as determined by the MRI technologists and radiologists.

9. A history of allergy to iodides

10. A GFR < 30 ml/min as determined by blood test on the day of NIR/MR imaging, or from lab results within 3 months of DCE-MRI for this study

Closed Fracture Cohort (Cohort 2)

1. Fracture of the hand.

2. Iodine allergy.

3. Chronic or acute infection at or near the fracture site at the time of initial fracture surgery.

4. Burns at the fracture site.

5. Incarceration.

6. Expected survival of less than 90 days.

7. Problems, in the judgment of study personnel, with maintaining follow-up with the patient.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Dartmouth-Hitchcock Medical Center
  • Collaborator
    • Dartmouth College
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ida Leah Gitajn, Physician – Dartmouth-Hitchcock Medical Center
  • Overall Official(s)
    • Ida L Gitajn, MD, Principal Investigator, Dartmouth-Hitchcock Medical Center
  • Overall Contact(s)
    • Amy Hall, MS, 603-653-3306, amy.e.hall@hitchcock.org

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