Study of ICG Fluorescence Imaging in Open Fracture and Infection Patients

ConditionsFractures, Bone Trauma Injury

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorDartmouth-Hitchcock Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Inability of patient to provide informed consent

Fracture of the hand.

Iodine allergy.

Burns at the fracture site.

Trial population

Patients 18 years of age or older who present with an open fracture or fracture related infection.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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.

Treatment groups

10 Participants

are divided into 2 treatment groups

Group A: Established SSI Fracture Cohort1 intervention

Group B: Open Fracture Cohort1 intervention

Trial outcomes

Primary outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dartmouth-Hitchcock Medical Center

Lead sponsor

Dartmouth College

Collaborator

Source ClinicalTrials.gov

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