ICG Fluorescence Imaging in Open Fracture Trauma Patients

Trauma Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04416412
• Other study ID #: D20058
• Secondary ID: OR190062
• Status: Recruiting
• Start date: October 1, 2020
• Est. completion date: January 31, 2026

Study information

• Verified date: February 2024
• Source: Dartmouth-Hitchcock Medical Center
• Contact: Jon Mikael Anderson
• Phone: 603-653-3306
• Email: jon.mikael.anderson[@]hitchcock.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: January 31, 2026
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Trauma Injury
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	University of Maryland, Baltimore R. Cowley Shock Trauma	Baltimore	Maryland
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	University of California, Irvine	Irvine	California
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (6)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	Brigham and Women's Hospital, Dartmouth College, United States Department of Defense, University of California, Irvine, University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome

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