ICG Fluorescence Imaging in Open Fracture Trauma Patients

Active, not recruiting

• Conditions: Trauma Injury
• Interventions: Other: Immunofluorescence Imaging

• Registration Number: NCT04416412
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

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.

Study Timeline

• Study First Submitted: 2020-05-21
• Study First Submitted QC: 2020-06-03
• Study First Posted: 2020-06-04
• Study Start: 2020-10-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-01
• Primary Completion: 2026-01-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 180

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Open Fracture Cohort	Immunofluorescence Imaging	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.

Primary Outcome Measures

Name	Time	Method
Number of participants who undergo an unplanned fracture-related reoperation	12 months	All unplanned reoperations will be documented using a specific case report form
Number of participants who experience a post-procedure surgical site infection	12 months	Post-procedure surgical site infection using Centers for Disease Control criteria will be documented at each follow-up

Trial Locations

Locations (4)

University of California, Irvine; 🇺🇸 Irvine, California, United States

University of Maryland, Baltimore R. Cowley Shock Trauma; 🇺🇸 Baltimore, Maryland, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Dartmouth Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States