ICG Fluorescence Imaging in Trauma Patients

NCT ID: NCT04245111

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-05-16
• Study Completion Date: 2022-11-18

Brief Summary

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.

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 38 post-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 and 6 months 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, method of treatment(s), and date of resolution will be documented.

4/23/2020: Study recruitment temporarily halted due to COVID-19

Conditions

Trauma Injury

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Immunofluorescence Imaging

Intervention Type: OTHER

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.

Complication 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

Immunofluorescence Imaging

Intervention Type: OTHER

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.

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

Immunofluorescence Imaging

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Open Fracture Cohort (Cohort 1)

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.

Established SSI Fracture Cohort (Cohort 2)

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.

Closed Fracture Cohort (Cohort 3)

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

Open Fracture Cohort (Cohort 1)

1. Fracture of the hand.

2. Iodine allergy.

3. Received previous surgical debridement or management of their fracture at a non-participating hospital or clinic.

4. Open fracture managed outside of the participating orthopaedic service.

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

6. Burns at the fracture site.

7. Incarceration.

8. Expected survival of less than 90 days.

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

Established SSI Fracture Cohort (Cohort 2)

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 2-1)

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 3)

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dartmouth College

OTHER

Sponsor Role: collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Ida Leah Gitajn

Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ida L Gitajn, MD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Locations

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

D20027

Identifier Type: -

Identifier Source: org_study_id