An observational study in Trauma Injury, sponsored by Dartmouth-Hitchcock Medical Center. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by Dartmouth-Hitchcock Medical Center · Observational
This is a prospective observational study that will evaluate the association between bone and tissue perfusion, as measured by indocyanine green (ICG) fluorescence imaging, and complications, in an effort to develop ICG fluorescence imaging as a diagnostic tool to quantitatively guide operative debridement.
This is a prospective observational study that will evaluate the association between bone and tissue perfusion, as measured using indocyanine green (ICG) fluorescence imaging, and complications. This will be used to develop ICG fluorescence imaging as a diagnostic tool to objectively and quantitatively guide operative debridement. The study population includes all open fracture patients regardless of race, ethnicity, or sex/gender. Primary outcome measure is all-cause re-operation and secondary outcome measure is surgical site infection. All patients will be followed for a total of 12 months.
128 studies on the registry are indexed under Accidental Injuries; 39 are open to participants now.
This study's enrollment of 124 is below the median of 170 across 59 observational studies indexed under Accidental Injuries.
Browse Accidental Injuries studies →Dartmouth-Hitchcock Medical Center is the lead sponsor of 488 studies on the registry; 71 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 21 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients 18 years of age or older who present with an open fracture will be considered for the open fracture cohort.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: 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 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.
Number of participants who undergo an unplanned fracture-related reoperation
All unplanned reoperations will be documented using a specific case report form
Time frame: 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
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2020 to primary completion in Jul 2026, 69 months.
Of 33 non-industry observational studies under Accidental Injuries, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 60. This study's 69 months is above that.
Counting every sponsor, half of 39 studies reached it within 31 months; a quarter within 12 and three quarters within 60.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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