<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04416412</url>
  </required_header>
  <id_info>
    <org_study_id>D20058</org_study_id>
    <secondary_id>OR190062</secondary_id>
    <nct_id>NCT04416412</nct_id>
  </id_info>
  <brief_title>ICG Fluorescence Imaging in Open Fracture Trauma Patients</brief_title>
  <official_title>Optimizing Surgical Debridement Following High-energy Open Trauma With Dynamic Contrast-enhanced Fluorescence Imaging</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dartmouth-Hitchcock Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Dartmouth College</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>United States Department of Defense</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>Brigham and Women's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of California, Irvine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Maryland, Baltimore</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Dartmouth-Hitchcock Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective observational study that will evaluate the association between bone and&#xD;
      tissue perfusion, as measured by indocyanine green (ICG) fluorescence imaging, and&#xD;
      complications, in an effort to develop ICG fluorescence imaging as a diagnostic tool to&#xD;
      quantitatively guide operative debridement.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective observational study that will evaluate the association between bone and&#xD;
      tissue perfusion, as measured using indocyanine green (ICG) fluorescence imaging, and&#xD;
      complications. This will be used to develop ICG fluorescence imaging as a diagnostic tool to&#xD;
      objectively and quantitatively guide operative debridement. The study population includes all&#xD;
      open fracture patients regardless of race, ethnicity, or sex/gender. Primary outcome measure&#xD;
      is all-cause re-operation and secondary outcome measure is surgical site infection. All&#xD;
      patients will be followed for a total of 12 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 1, 2020</start_date>
  <completion_date type="Anticipated">January 31, 2026</completion_date>
  <primary_completion_date type="Anticipated">January 31, 2025</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>12 Months</target_duration>
  <primary_outcome>
    <measure>Number of participants who undergo an unplanned fracture-related reoperation</measure>
    <time_frame>12 months</time_frame>
    <description>All unplanned reoperations will be documented using a specific case report form</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants who experience a post-procedure surgical site infection</measure>
    <time_frame>12 months</time_frame>
    <description>Post-procedure surgical site infection using Centers for Disease Control criteria will be documented at each follow-up</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">180</enrollment>
  <condition>Trauma Injury</condition>
  <arm_group>
    <arm_group_label>Open Fracture Cohort</arm_group_label>
    <description>Patients 18 years of age or older. Open extremity fracture. Planned definitive fracture management with external fixation, internal fixation, or joint fusion.&#xD;
Open fracture wound management that includes formal surgical debridement within 72 hours of their injury.&#xD;
Will have all planned fracture care surgeries performed by a participating surgeon or delegate.&#xD;
Provision of informed consent.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Immunofluorescence Imaging</intervention_name>
    <description>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.</description>
    <arm_group_label>Open Fracture Cohort</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients 18 years of age or older who present with an open fracture will be considered for&#xD;
        the open fracture cohort.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients 18 years of age or older.&#xD;
&#xD;
          2. Open extremity fracture.&#xD;
&#xD;
          3. Planned definitive fracture management with external fixation, internal fixation, or&#xD;
             joint fusion.&#xD;
&#xD;
          4. Open fracture wound management that includes formal surgical debridement within 72&#xD;
             hours of their injury.&#xD;
&#xD;
          5. Will have all planned fracture care surgeries performed by a participating surgeon or&#xD;
             delegate.&#xD;
&#xD;
          6. Provision of informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Inability of patient to provide informed consent&#xD;
&#xD;
          2. Fracture of the hand.&#xD;
&#xD;
          3. Iodine allergy.&#xD;
&#xD;
          4. Received previous surgical debridement or management of their fracture at a&#xD;
             non-participating hospital or clinic.&#xD;
&#xD;
          5. Open fracture managed outside of the participating orthopaedic service.&#xD;
&#xD;
          6. Chronic or acute infection at or near the fracture site at the time of initial&#xD;
             fracture surgery.&#xD;
&#xD;
          7. Burns at the fracture site.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ida L Gitajn, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dartmouth-Hitchcock Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Melanie L. Christian</last_name>
    <phone>603-650-3556</phone>
    <email>Melanie.l.christian@hitchcock.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of California, Irvine</name>
      <address>
        <city>Irvine</city>
        <state>California</state>
        <zip>92614</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Susan Demas</last_name>
      <phone>714-456-7710</phone>
      <email>sdemas@hs.uci.edu</email>
    </contact>
    <investigator>
      <last_name>John Scolaro</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Maryland, Baltimore R. Cowley Shock Trauma</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Heather Phipps</last_name>
      <phone>410-706-7180</phone>
      <email>hphipps@som.umaryland.edu</email>
    </contact>
    <investigator>
      <last_name>Gerard Slobogean, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Brigham and Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>021115</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Abigail Sagona</last_name>
      <phone>617-732-5322</phone>
      <email>asagona@bwh.harvard.edu</email>
    </contact>
    <investigator>
      <last_name>Michael J Weaver</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Dartmouth Hitchcock Medical Center</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03756</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ida L Gitajn, MD</last_name>
      <phone>603-650-5000</phone>
      <email>ida.l.gitajn@hitchcock.org</email>
    </contact>
    <contact_backup>
      <last_name>Melanie L Christian</last_name>
      <phone>603-650-3556</phone>
      <email>melanie.l.christian@hitchcock.org</email>
    </contact_backup>
    <investigator>
      <last_name>Ida L. Gitajn, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>February 16, 2023</last_update_submitted>
  <last_update_submitted_qc>February 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dartmouth-Hitchcock Medical Center</investigator_affiliation>
    <investigator_full_name>Ida Leah Gitajn</investigator_full_name>
    <investigator_title>Physician</investigator_title>
  </responsible_party>
  <keyword>Immunofluorescence</keyword>
  <keyword>Orthopaedic</keyword>
  <keyword>Trauma</keyword>
  <keyword>Open Fracture</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04416412
org study id: D20058
secondary id: OR190062
nct id: NCT04416412
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: Number of participants who undergo an unplanned fracture-related reoperation
time frame: 12 months
description: All unplanned reoperations will be documented using a specific case report form
measure: Number of participants who experience a post-procedure surgical site infection
time frame: 12 months
description: Post-procedure surgical site infection using Centers for Disease Control criteria will be documented at each follow-up
arm group label: Open Fracture Cohort
description: 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.
intervention type: Other
intervention name: Immunofluorescence Imaging
description: 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.
arm group label: Open Fracture Cohort
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ida L Gitajn, MD
role: Principal Investigator
affiliation: Dartmouth-Hitchcock Medical Center
last name: Melanie L. Christian
phone: 603-650-3556
email: Melanie.l.christian@hitchcock.org
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Dartmouth-Hitchcock Medical Center
investigator full name: Ida Leah Gitajn
investigator title: Physician
mesh term: Wounds and Injuries
sharing ipd: No