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ICG Fluorescence Imaging in Trauma Patients

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ClinicalTrials.gov Identifier: NCT04245111
Recruitment Status : Recruiting
First Posted : January 28, 2020
Last Update Posted : June 30, 2020
Sponsor:
Collaborator:
Dartmouth College
Information provided by (Responsible Party):
Ida Leah Gitajn, Dartmouth-Hitchcock Medical Center

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.

Condition or disease Intervention/treatment
Trauma Injury Other: Immunofluorescence Imaging

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

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 358 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: ICG Fluorescence Imaging in Trauma Patients
Actual Study Start Date : May 5, 2020
Estimated Primary Completion Date : June 30, 2025
Estimated Study Completion Date : January 31, 2026

Resource links provided by the National Library of Medicine


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 (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
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.

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

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.




Primary Outcome Measures :
  1. Post procedure surgical site infection [ Time Frame: six months ]
    Post-procedure surgical site infection using CDC criteria will be documented at each follow-up appointment up to six months

  2. Unplanned fracture-related reoperation [ Time Frame: six months ]
    All unplanned reoperations will be documented



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 (Cohort 1). Similarly fracture patients who present with an SSI following fracture fixation or joint fusion will be screened for the fracture SSI cohort (Cohort 2). Patients who present with a closed fracture will be considered for the closed fracture cohort (Cohort 3).
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04245111


Contacts
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Contact: Amy Hall, MS 603-653-3306 amy.e.hall@hitchcock.org
Contact: Rebecca Dabrowski 603-653-3306 rebecca.e.dabrowski@hitchcock.org

Locations
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United States, New Hampshire
Dartmouth Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Ida L Gitajn, MD    603-650-5000    ida.l.gitajn@hitchcock.org   
Contact: Amy E Hall, MS    603-653-3306    amy.e.hall@hitchcock.org   
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Dartmouth College
Investigators
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Principal Investigator: Ida L Gitajn, MD Dartmouth-Hitchcock Medical Center
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Responsible Party: Ida Leah Gitajn, Physician, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT04245111    
Other Study ID Numbers: D20027
First Posted: January 28, 2020    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ida Leah Gitajn, Dartmouth-Hitchcock Medical Center:
Immunofluorescence
Orthopaedic
Trauma
Additional relevant MeSH terms:
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Wounds and Injuries