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ICG Fluorescence Imaging in Open Fracture Trauma Patients

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ClinicalTrials.gov Identifier: NCT04416412
Recruitment Status : Recruiting
First Posted : June 4, 2020
Last Update Posted : January 27, 2022
Sponsor:
Collaborators:
Dartmouth College
United States Department of Defense
Brigham and Women's Hospital
University of California, Irvine
University of Maryland, Baltimore
Information provided by (Responsible Party):
Ida Leah Gitajn, Dartmouth-Hitchcock Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment
Trauma Injury 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 180 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Optimizing Surgical Debridement Following High-energy Open Trauma With Dynamic Contrast-enhanced Fluorescence Imaging
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : January 31, 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 (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. Number of participants who undergo an unplanned fracture-related reoperation [ Time Frame: 12 months ]
    All unplanned reoperations will be documented using a specific case report form

  2. Number of participants who experience a post-procedure surgical site infection [ Time Frame: 12 months ]
    Post-procedure surgical site infection using Centers for Disease Control criteria will be documented at each follow-up



Information from the National Library of Medicine

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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.
Criteria

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.

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): NCT04416412


Contacts
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Contact: Melanie L. Christian 603-650-3556 Melanie.l.christian@hitchcock.org

Locations
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United States, California
University of California, Irvine Recruiting
Irvine, California, United States, 92614
Contact: Susan Demas    714-456-7710    sdemas@hs.uci.edu   
Principal Investigator: John Scolaro         
United States, Maryland
University of Maryland, Baltimore R. Cowley Shock Trauma Recruiting
Baltimore, Maryland, United States, 21201
Contact: Heather Phipps    410-706-7180    hphipps@som.umaryland.edu   
Principal Investigator: Gerard Slobogean, MD         
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 021115
Contact: Abigail Sagona    617-732-5322    asagona@bwh.harvard.edu   
Principal Investigator: Michael J Weaver         
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: Melanie L Christian    603-650-3556    melanie.l.christian@hitchcock.org   
Principal Investigator: Ida L. Gitajn, MD         
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Dartmouth College
United States Department of Defense
Brigham and Women's Hospital
University of California, Irvine
University of Maryland, Baltimore
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: NCT04416412    
Other Study ID Numbers: D20058
OR190062 ( Other Grant/Funding Number: Department of Defense )
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: January 27, 2022
Last Verified: January 2022
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
Open Fracture
Additional relevant MeSH terms:
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Wounds and Injuries