Fractures, Bone, Trauma Injury
Conditions
Keywords
Immunofluorescence, Orthopaedic Trauma, Infection
Brief summary
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
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 near-infrared light. The ICG dye is indirectly activated and the dynamic fluorescence due to bone perfusion can be captured by a video rate imaging system.
Sponsors
Dartmouth-Hitchcock Medical Center
Dartmouth College
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who undergo an unplanned fracture-related reoperation | 12 Months | All unplanned reoperations will be documented using a specific case report form |
| Number of participants who experience a post-procedure surgical site infection | 12 Months | Post-procedure surgical site infection using Centers for Disease Control criteria will be documented at each follow-up |
Countries
United States
Contacts
CONTACTJon Mikael Anderson
CONTACTIda L Gitajn, MD
PRINCIPAL_INVESTIGATORIda L Gitajn, MD
Dartmouth-Hitchcock Medical Center
Outcome results
None listed