Study of ICG Fluorescence Imaging in Open Fracture and Infection Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Immunofluorescence Imaging.
- Who it may be relevant to
- Registry conditions: Fractures, Bone, Trauma Injury. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective Observational Study of ICG Fluorescence Imaging in Open Fracture and Infection Patients: Early Comparison With a Novel Imaging Device
Overview
The purpose of this study is to determine whether an indocyanine green (ICG) fluorescence imaging system (cBPI) can be used to provide surgeons with information about bone health or bone blood flow. This will help surgeons better understand the healing potential of bone and relative risk of complication. This is important to help surgeons select the most appropriate treatment for severe traumatic injuries and infections.
Interventions
- Drug 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 ne
Primary outcome measures
- Number of participants who undergo an unplanned fracture-related reoperation [Time frame: 12 Months]
- Number of participants who experience a post-procedure surgical site infection [Time frame: 12 Months]
Eligibility criteria
Inclusion criteria
- Patients 18 years of age or older.
- Open extremity fracture, planning for management with external fixation, internal fixation or joint fusion.
- Fracture Related Infection, planning for management with debridement and possible removal of hardware.
- Will have all planned fracture care surgeries performed by a participating surgeon or delegate.
- Provision of informed consent.
Exclusion criteria
- Inability of patient to provide informed consent
- Fracture of the hand.
- Iodine allergy.
- Burns at the fracture site.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Dartmouth-Hitchcock Medical Center — Lebanon
Identifiers
NCT: NCT06793644 · STUDY02002551