ICG Fluorescence Imaging in Open Fracture Trauma Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04416412|
Recruitment Status : Recruiting
First Posted : June 4, 2020
Last Update Posted : January 27, 2022
|Condition or disease||Intervention/treatment|
|Trauma Injury||Other: Immunofluorescence Imaging|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||180 participants|
|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|
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.
- 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
- 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
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
|Contact: Melanie L. Christian||603-650-3556||Melanie.firstname.lastname@example.org|
|United States, California|
|University of California, Irvine||Recruiting|
|Irvine, California, United States, 92614|
|Contact: Susan Demas 714-456-7710 email@example.com|
|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 firstname.lastname@example.org|
|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 email@example.com|
|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 firstname.lastname@example.org|
|Contact: Melanie L Christian 603-650-3556 email@example.com|
|Principal Investigator: Ida L. Gitajn, MD|
|Principal Investigator:||Ida L Gitajn, MD||Dartmouth-Hitchcock Medical Center|