Trauma Injury Clinical Trial
Official title:
Real-time Fluorescence-based Measurement of Bone Perfusion in Post-traumatic Infection
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) examine the relationship between perfusion and complications such as surgical site infection (SSI), persistent SSI, and fracture nonunion; (3) to determine whether the quantitative ICG fluorescence can be used to guide bony debridement in the setting of infected fracture to minimize complications.
Status | Recruiting |
Enrollment | 170 |
Est. completion date | May 31, 2025 |
Est. primary completion date | May 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Established SSI Fracture (Cohort Cohort 1, Group 1) 1. Patients 18 years of age or older. 2. Extremity fracture. 3. Prior definitive fracture management with external fixation, internal fixation, or joint fusion. 4. Superficial, deep, or organ space SSI (as per CDC criteria) at the fracture site that requires operative management. 5. Will have all fracture care surgeries performed by a participating surgeon or delegate. 6. Provision of informed consent. Subset: DCE-MRI (Cohort 1-1, Group 2) 1. Patients 18 years of age or older. 2. Closed extremity fracture. 3. Planned definitive fracture management with external fixation, internal fixation, or joint fusion. 4. Will have all planned fracture care surgeries performed by a participating surgeon or delegate. 5. Provision of informed consent. Exclusion Criteria: Established SSI Fracture Cohort (Cohort 1, Group 1) 1. Fracture of the hand. 2. Iodine allergy. 3. Received previous surgical debridement to manage the SSI. 4. Incarceration. 5. Problems, in the judgment of study personnel, with maintaining follow-up with the patient. Subset: DCE-MRI (Cohort 1-1, Group2) 6. the presence of an electronic implant, such as a pacemaker 7. the presence of a metal implant, such as an aneurysm clip 8. the presence of other contraindication(s), as determined by the MRI technologists and radiologists. 9. A history of allergy to iodides 10. 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Maryland, Baltimore R. Adams Cowley Shock Trauma | Baltimore | Maryland |
United States | Brigham and Women's Hospital | Boston | Massachusetts |
United States | University of California, Irvine | Irvine | California |
United States | Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire |
Lead Sponsor | Collaborator |
---|---|
Dartmouth-Hitchcock Medical Center | Brigham and Women's Hospital, Dartmouth College, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), University of California, Irvine, University of Maryland, Baltimore |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patients experiencing post procedure surgical site infections | Post-procedure surgical site infection using CDC criteria will be documented at each follow-up appointment up to one year | 1 year | |
Primary | Number of patients requiring unplanned fracture-related reoperations | All unplanned reoperations will be documented | 1 year |
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