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| Name | Class |
|---|---|
| Dartmouth College | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Established SSI Fracture Cohort | 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 |
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| Open Fracture Cohort | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunofluorescence Imaging | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who undergo an unplanned fracture-related reoperation | All unplanned reoperations will be documented using a specific case report form | 12 Months |
| Number of participants who experience a post-procedure surgical site infection | Post-procedure surgical site infection using Centers for Disease Control criteria will be documented at each follow-up | 12 Months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients 18 years of age or older who present with an open fracture or fracture related infection.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jon Mikael Anderson | Contact | 603-653-3306 | jon.mikael.anderson@hitchcock.org | |
| Ida L Gitajn, MD | Contact | 603-650-5000 | ida.l.gitajn@hitchcock.org |
| Name | Affiliation | Role |
|---|---|---|
| Ida L Gitajn, MD | Dartmouth-Hitchcock Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth-Hitchcock Medical Center | Recruiting | Lebanon | New Hampshire | 03756 | United States |
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| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D000081084 | Accidental Injuries |
| D007239 | Infections |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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