ICG Fluorescence Imaging in Trauma Patients

NCT04245111 | Completed Results

• 1 other identifier: D20027
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a prospective observational trial to better understand the range and variation associated with bone/soft tissue perfusion in fracture patients and examine the relationship between perfusion, measured using quantitative Indocyanine green (ICG) fluorescence and complications such as surgical site infection (SSI), persistent SSI, and fracture nonunion.

Conditions

Trauma Injury

Keywords

Immunofluorescence; Orthopaedic; Trauma

Outcome Measures

Primary Outcomes (1)

• Percent of Patients That Complete the Protocol

  As this is a pilot and feasibility study, the outcome measure is the percent of patients that successfully complete the protocol.

  1 year

Study Arms (3)

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

Complication Cohort

Patients 18 years of age or older. Extremity fracture. Prior definitive fracture management with external fixation, internal fixation, or joint fusion. Superficial, deep, or organ space SSI (as per CDC criteria) at the fracture site that requires operative management. Will have all fracture care surgeries performed by a participating surgeon or delegate. Provision of informed consent

Other: Immunofluorescence Imaging

Closed Fracture Cohort

Patients 18 years of age or older Closed extremity fracture Planned definitive fracture management with external fixation, internal fixation, or joint fusion. Provision of informed consent

Other: Immunofluorescence Imaging

Interventions

Immunofluorescence Imaging OTHER

Patients will be administered FDA approved ICG through intravenous injection and imaged by a FDA approved surgical microscope (Pentero or 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.

Closed Fracture Cohort; Complication Cohort; Open Fracture Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients 18 years of age or older who present with an open fracture will be considered for the open fracture cohort (Cohort 1). Similarly fracture patients who present with an SSI following fracture fixation or joint fusion will be screened for the fracture SSI cohort (Cohort 2). Patients who present with a closed fracture will be considered for the closed fracture cohort (Cohort 3).

You may qualify if:

• Open Fracture Cohort (Cohort 1)
• 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.
• Established SSI Fracture Cohort (Cohort 2)
• Patients 18 years of age or older.
• Extremity fracture.
• Prior definitive fracture management with external fixation, internal fixation, or joint fusion.
• Superficial, deep, or organ space SSI (as per CDC criteria) at the fracture site that requires operative management.
• Will have all fracture care surgeries performed by a participating surgeon or delegate.
• Provision of informed consent.
• Closed Fracture Cohort (Cohort 3)

You may not qualify if:

• Open Fracture Cohort (Cohort 1)
• Fracture of the hand.
• Iodine allergy.
• Received previous surgical debridement or management of their fracture at a non-participating hospital or clinic.
• Open fracture managed outside of the participating orthopaedic service.
• Chronic or acute infection at or near the fracture site at the time of initial fracture surgery.
• Burns at the fracture site.
• Incarceration.
• Expected survival of less than 90 days.
• Problems, in the judgment of study personnel, with maintaining follow-up with the patient.
• Established SSI Fracture Cohort (Cohort 2)
• Fracture of the hand.
• Iodine allergy.
• Received previous surgical debridement to manage the SSI.
• Incarceration.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• Dartmouth College: collaborator

Study Sites (1)

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Accidental Injuries; Wounds and Injuries

Results Point of Contact

• Title: Dr. Ida Leah Gitajn
• Organization: Dartmouth Health Orthopaedics

Ida.Leah.Gitajn@hitchcock.org

(603) 650-5133

Study Officials

• Ida L Gitajn, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: January 22, 2020
• First Posted: January 28, 2020
• Study Start: May 16, 2019
• Primary Completion: November 23, 2021
• Study Completion: November 18, 2022
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)