Clinical trial NCT04416412: ICG Fluorescence Imaging in Open Fracture Trauma Patients
Official title: Optimizing Surgical Debridement Following High-energy Open Trauma With Dynamic Contrast-enhanced Fluorescence Imaging
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Trauma Injury
Keywords: Immunofluorescence
Orthopaedic
Trauma
Open Fracture
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Dartmouth College
name: United States Department of Defense
name: Brigham and Women's Hospital
name: University of California, Irvine
name: University of Maryland, Baltimore
First posted: 2020-06-04
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients 18 years of age or older who present with an open fracture will be considered for the open fracture cohort.

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants who undergo an unplanned fracture-related reoperation
timeFrame: 12 months
measure: Number of participants who experience a post-procedure surgical site infection
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: University of California, Irvine
state: California
city: Baltimore
country: United States
facility: University of Maryland, Baltimore R. Cowley Shock Trauma
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Ida L Gitajn, MD
role: PRINCIPAL_INVESTIGATOR
References: