ICG Fluorescence Imaging in Open Fracture Trauma Patients

• Sponsor: Dartmouth-Hitchcock Medical Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04416412
• Collaborator: Dartmouth College (Other), United States Department of Defense (U.S. Fed), Brigham and Women's Hospital (Other), University of California, Irvine (Other), University of Maryland, Baltimore (Other)
• Enrollment: 180
• Locations: 4
• Anticipated Duration (Months): 64
• Patients Per Site: 45
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Trauma Injury	Other: Immunofluorescence Imaging

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 Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 180 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Optimizing Surgical Debridement Following High-energy Open Trauma With Dynamic Contrast-enhanced Fluorescence Imaging
• Actual Study Start Date: Oct 1, 2020
• Anticipated Primary Completion Date: Jan 31, 2025
• Anticipated Study Completion Date: Jan 31, 2026

Arms and Interventions

Arm

Intervention/Treatment

Open Fracture Cohort 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.

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.

Outcome Measures

Primary Outcome Measures

1. Number of participants who undergo an unplanned fracture-related reoperation [12 months]

   All unplanned reoperations will be documented using a specific case report form

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, Irvine	Irvine	California	United States	92614
2	University of Maryland, Baltimore R. Cowley Shock Trauma	Baltimore	Maryland	United States	21201
3	Brigham and Women's Hospital	Boston	Massachusetts	United States	021115
4	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Ida L Gitajn, MD, Dartmouth-Hitchcock Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ida Leah Gitajn, Physician, Dartmouth-Hitchcock Medical Center
• ClinicalTrials.gov Identifier: NCT04416412
• Other Study ID Numbers: D20058; OR190062
• First Posted: Jun 4, 2020
• Last Update Posted: Jan 27, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ida Leah Gitajn, Physician, Dartmouth-Hitchcock Medical Center: Immunofluorescence; Orthopaedic; Trauma; Open Fracture
• Additional relevant MeSH terms: Wounds and Injuries

Study Results

No Results Posted as of Jan 27, 2022