Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Irvine, California and other locations
Dates
study started
estimated completion
Principal Investigator
by John Scolaro

Description

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.

Official Title

Optimizing Surgical Debridement Following High-energy Open Trauma With Dynamic Contrast-enhanced Fluorescence Imaging

Details

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.

Keywords

Trauma Injury Immunofluorescence Orthopaedic Trauma Open Fracture Wounds and Injuries Immunofluorescence Imaging

Eligibility

You can join if…

Open to people ages 18 years and up

  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.

You CAN'T join if...

  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.

Locations

  • University of California, Irvine accepting new patients
    Irvine California 92614 United States
  • University of Maryland, Baltimore R. Cowley Shock Trauma accepting new patients
    Baltimore Maryland 21201 United States

Lead Scientist at UC Irvine

  • John Scolaro
    Associate Clinical Professor, Orthopaedic Surgery. Authored (or co-authored) 73 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Dartmouth-Hitchcock Medical Center
ID
NCT04416412
Study Type
Observational [Patient Registry]
Participants
Expecting 180 study participants
Last Updated