Status:
ACTIVE_NOT_RECRUITING
ICG Fluorescence Imaging in Open Fracture Trauma Patients
Lead Sponsor:
Dartmouth-Hitchcock Medical Center
Collaborating Sponsors:
Dartmouth College
United States Department of Defense
Conditions:
Trauma Injury
Eligibility:
All Genders
18+ years
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 ef...
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Inability of patient to provide informed consent
- Fracture of the hand.
- Iodine allergy.
- Received previous surgical debridement or management of their fracture at a non-participating hospital or clinic.
- Open fracture managed outside of the participating orthopaedic service.
- Chronic or acute infection at or near the fracture site at the time of initial fracture surgery.
- Burns at the fracture site.
Key Trial Info
Start Date :
October 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 31 2026
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT04416412
Start Date
October 1 2020
End Date
January 31 2026
Last Update
May 1 2025
Active Locations (4)
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1
University of California, Irvine
Irvine, California, United States, 92614
2
University of Maryland, Baltimore R. Cowley Shock Trauma
Baltimore, Maryland, United States, 21201
3
Brigham and Women's Hospital
Boston, Massachusetts, United States, 021115
4
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756