N/A
N=20
ICG Fluorescence Imaging in Trauma Patients
Trauma Injury
Bottom Line
View on ClinicalTrials.gov: NCT04245111 ↗Enrolled (actual)
20
Serious AEs
20.0%
Results posted
Sep 2024
Primary outcome: Primary: Percent of Patients That Complete the Protocol — 61.5; 83.3; 0 percentage of completed patients
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Immunofluorescence Imaging (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Patients That Complete the Protocol |
61.5; 83.3; 0 | — |
Summary
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 perfusion, measured using quantitative Indocyanine green (ICG) fluorescence and complications such as surgical site infection (SSI), persistent SSI, and fracture nonunion.
Eligibility Criteria
Inclusion Criteria
Open Fracture Cohort (Cohort 1)
- 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.
Established SSI Fracture Cohort (Cohort 2)
- 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.
Closed Fracture Cohort (Cohort 3)
- 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 Criteria
Open Fracture Cohort (Cohort 1)
- 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.
- Incarceration.
- Expected survival of less than 90 days.
- Problems, in the judgment of study personnel, with maintaining follow-up with the patient.
Established SSI Fracture Cohort (Cohort 2)
- 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 2-1)
- 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
Closed Fracture Cohort (Cohort 3)
- Fracture of the hand.
- Iodine allergy.
- Chronic or acute infection at or near the fracture site at the time of initial fracture surgery.
- Burns at the fracture site.
- Incarceration.
- Expected survival of less than 90 days.
- Problems, in the judgment of study personnel, with maintaining follow-up with the patient.
Data sourced from ClinicalTrials.gov (NCT04245111). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.