Print

Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Patients 18 years of age or older. 2. Open extremity fracture. 3. Planned definitive fracture management with external fixation, internal fixation, or joint fusion. 4. Open fracture wound management that includes formal surgical debridement within 72 hours of their injury. 5. Will have all planned fracture care surgeries performed by a participating surgeon or delegate. 6. Provision of informed consent.

Exclusion Criteria

  1. Inability of patient to provide informed consent 2. Fracture of the hand. 3. Iodine allergy. 4. Received previous surgical debridement or management of their fracture at a non-participating hospital or clinic. 5. Open fracture managed outside of the participating orthopaedic service. 6. Chronic or acute infection at or near the fracture site at the time of initial fracture surgery. 7. Burns at the fracture site.

Study Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • 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.

Recruiting Locations

University of Maryland, Baltimore R. Cowley Shock Trauma
Baltimore, Maryland 21201
Contact:
Heather Phipps
410-706-7180
hphipps@som.umaryland.edu

More Details

Status
Recruiting
Sponsor
Dartmouth-Hitchcock Medical Center

Study Contact

Jon Mikael Anderson
603-653-3306
jon.mikael.anderson@hitchcock.org

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.