Status:
ACTIVE_NOT_RECRUITING
ICG Fluorescence Imaging in Post-traumatic Infection
Lead Sponsor:
Dartmouth-Hitchcock Medical Center
Collaborating Sponsors:
Dartmouth College
University of Maryland, Baltimore
Conditions:
Trauma Injury
Eligibility:
All Genders
18+ years
Brief Summary
The focus of this prospective observational study is to (1) establish the range and variation associated with bone/soft tissue perfusion in fracture patients, using ICG fluorescence imaging; (2) exami...
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 perfusi...
Eligibility Criteria
Inclusion
- Established SSI Fracture (Cohort Cohort 1, Group 1)
- 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.
- Subset: DCE-MRI (Cohort 1-1, Group 2)
- Patients 18 years of age or older.
- Closed extremity fracture.
- Planned definitive fracture management with external fixation, internal fixation, or joint fusion.
- Will have all planned fracture care surgeries performed by a participating surgeon or delegate.
- Provision of informed consent.
Exclusion
- Established SSI Fracture Cohort (Cohort 1, Group 1)
- Fracture of the hand.
- Iodine allergy.
- Received previous surgical debridement to manage the SSI.
- Incarceration.
- Problems, in the judgment of study personnel, with maintaining follow-up with the patient.
- Subset: DCE-MRI (Cohort 1-1, Group2)
- the presence of an electronic implant, such as a pacemaker
- the presence of a metal implant, such as an aneurysm clip
- the presence of other contraindication(s), as determined by the MRI technologists and radiologists.
- A history of allergy to iodides
- 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
Key Trial Info
Start Date :
September 14 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT04403204
Start Date
September 14 2020
End Date
December 31 2025
Last Update
January 23 2025
Active Locations (4)
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1
University of California, Irvine
Irvine, California, United States, 92614
2
University of Maryland, Baltimore R. Adams Cowley Shock Trauma
Baltimore, Maryland, United States, 21201
3
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
4
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756