ICG Fluorescence Imaging in Post-traumatic Infection

NCT04403204 | Completed

• 2 other identifiers: D200571R01AR077157-01
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 4

Brief Summary

The focus of this prospective observational study is to (1) establish the range and variation associated with bone/soft tissue perfusion in fracture patients, using ICG fluorescence imaging; (2) examine the relationship between perfusion and complications such as surgical site infection (SSI), persistent SSI, and fracture nonunion; (3) to determine whether the quantitative ICG fluorescence can be used to guide bony debridement in the setting of infected fracture to minimize complications.

Conditions

Trauma Injury

Keywords

Immunofluorescence; Orthopaedic; Trauma; Infection

Outcome Measures

Primary Outcomes (2)

• Number of patients experiencing post procedure surgical site infections

  Post-procedure surgical site infection using CDC criteria will be documented at each follow-up appointment up to one year

  1 year

• Number of patients requiring unplanned fracture-related reoperations

  All unplanned reoperations will be documented

  1 year

Study Arms (2)

Established SSI Fracture 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

Established SSI Fracture Cohort Subset (DCE-MRI)

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; Other: DCE-MRI

Interventions

Immunofluorescence Imaging OTHER

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.

Established SSI Fracture Cohort; Established SSI Fracture Cohort Subset (DCE-MRI)

DCE-MRI OTHER

Characterize the relationship between bone perfusion as quantified by ICG based DCE-FI and DCE-MRI in human patients to develop an accurate depth-sensitive fluorescence imaging model that will correct for the surface-weighted feature of fluorescence imaging

Established SSI Fracture Cohort Subset (DCE-MRI)

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 SSI following fracture or joint fusion Established SSI fracture cohort (Cohort 1). A subset of Cohort 1 will be considered for the Subset DCE-MRI cohort (Cohort 1-1).

You may qualify if:

• Established SSI Fracture (Cohort Cohort 1, Group 1)
• 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.
• Subset: DCE-MRI (Cohort 1-1, Group 2)
• Patients 18 years of age or older.
• Closed extremity fracture.
• Planned definitive fracture management with external fixation, internal fixation, or joint fusion.
• Will have all planned fracture care surgeries performed by a participating surgeon or delegate.
• Provision of informed consent.

You may not qualify if:

• Established SSI Fracture Cohort (Cohort 1, Group 1)
• Fracture of the hand.
• Iodine allergy.
• Received previous surgical debridement to manage the SSI.
• Incarceration.
• Problems, in the judgment of study personnel, with maintaining follow-up with the patient.
• Subset: DCE-MRI (Cohort 1-1, Group2)
• the presence of an electronic implant, such as a pacemaker
• the presence of a metal implant, such as an aneurysm clip
• the presence of other contraindication(s), as determined by the MRI technologists and radiologists.
• A history of allergy to iodides
• A GFR \< 30 ml/min as determined by blood test on the day of NIR/MR imaging, or from lab results within 3 months of DCE-MRI for this study

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• Dartmouth College: collaborator
• University of Maryland, Baltimore: collaborator
• University of California, Irvine: collaborator
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (4)

University of California, Irvine

Irvine, California, 92614, United States

Location

University of Maryland, Baltimore R. Adams Cowley Shock Trauma

Baltimore, Maryland, 21201, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Accidental Injuries; Wounds and Injuries; Infections

Study Officials

• Ida L Gitajn, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: May 21, 2020
• First Posted: May 27, 2020
• Study Start: September 14, 2020
• Primary Completion: October 8, 2025
• Study Completion: October 8, 2025
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)