ICG Fluorescence Imaging in Open Fracture Trauma Patients

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Dartmouth Health

Status

Enrolling

Conditions

Trauma Injury

Treatments

Other: Immunofluorescence Imaging

Study type

Observational

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT04416412
OR190062 (Other Grant/Funding Number)
D20058

Details and patient eligibility

About

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.

Full 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.

Enrollment

180 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

180 participants in 1 patient group

Open Fracture Cohort
Description:
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.
Treatment:
Other: Immunofluorescence Imaging

Trial contacts and locations

4

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Central trial contact

Jon Mikael Anderson

Data sourced from clinicaltrials.gov

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