Trauma InjuryNCT04245111
ICG Fluorescence Imaging in Trauma Patients
An observational study of Trauma Injury, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma Injury
- What is being tested?
- Immunofluorescence Imaging
- Type of treatment
- Injection or infusion
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2019to 18 Nov 2022
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
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- 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)
- 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.
Who cannot join
- 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.
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- 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.
- Problems, in the judgment of study personnel, with maintaining follow-up with the patient.
- Subset: DCE-MRI (Cohort 2-1)
- 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
- Closed Fracture Cohort (Cohort 3)
- Fracture of the hand.
- Iodine allergy.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
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.
Read the detailed description
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. Primary outcome measure is complication (either infection, recurrent infection or nonunion). Eligible consenting patients will receive standard of care treatment for their fracture or infection including irrigation and debridement of their operative site and/or fracture fixation. After exposure, 0.1 mg/Kg ICG will be injected intravenously and video rate ICG fluorescence images will be acquired 20 seconds before and 4 minutes after the injection, each before and after debridement. A subset of 38 post-fracture complication patients will undergo surgical treatment for their infection in Center of Innovation Surgery (CIS) and have either an intraoperative Dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) after exposure but before the ICG injection or a preoperative DCE-MRI. Patients receiving surgery in the CIS will be required to sign an additional CIS-specific consent document. The need for repeat surgical procedure will be left up to the treating surgeon. If repeat procedure is needed, pre- and post-debridement quantitative ICG fluorescence images will be obtained at each procedure. Study participants will be followed at 2 weeks, 6 weeks, 3 months and 6 months from their index study surgery. Complication including index infection, recurrent infection or delaying union/nonunion will be identified at the time of diagnosis and/or during each participants assessment that occurs during routine outpatient clinic visit. Detailed information on the infection including date of diagnosis, participant signs and symptoms, culture test results, method of treatment(s), and date of resolution will be documented.
4/23/2020: Study recruitment temporarily halted due to COVID-19
- Conditions
- Trauma Injury
- Being tested
- Immunofluorescence Imaging
- Keywords
- Immunofluorescence, Orthopaedic, Trauma
- Medical subject headings
- Accidental Injuries, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunofluorescence ImagingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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 Receives: Other: Immunofluorescence Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start16 May 2019
- Primary completion23 Nov 2021
- Study completion18 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Trauma InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dartmouth College
- Responsible party
- Principal investigator, Ida Leah Gitajn, Dartmouth-Hitchcock Medical Center
- Investigators
- Ida L Gitajn, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04245111
- Sponsor's protocol ID
- D20027
- Status last verified
- May 2024
- First submitted
- 22 Jan 2020
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ICG Fluorescence Imaging in Trauma Patients
- ClinicalTrials.gov ID
- NCT04245111
- Acronym / sponsor ID
- D20027
- Conditions
- Trauma Injury
- Keywords
- Immunofluorescence, Orthopaedic, Trauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- Dartmouth College
- Study start
- 16 May 2019 (actual)
- Primary completion
- 23 Nov 2021 (actual)
- Study completion
- 18 Nov 2022 (actual)
- First posted
- 28 Jan 2020 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. Primary outcome measure is complication (either infection, recurrent infection or nonunion). Eligible consenting patients will receive standard of care treatment for their fracture or infection including irrigation and debridement of their operative site and/or fracture fixation. After exposure, 0.1 mg/Kg ICG will be injected intravenously and video rate ICG fluorescence images will be acquired 20 seconds before and 4 minutes after the injection, each before and after debridement. A subset of 38 post-fracture complication patients will undergo surgical treatment for their infection in Center of Innovation Surgery (CIS) and have either an intraoperative Dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) after exposure but before the ICG injection or a preoperative DCE-MRI. Patients receiving surgery in the CIS will be required to sign an additional CIS-specific consent document. The need for repeat surgical procedure will be left up to the treating surgeon. If repeat procedure is needed, pre- and post-debridement quantitative ICG fluorescence images will be obtained at each procedure. Study participants will be followed at 2 weeks, 6 weeks, 3 months and 6 months from their index study surgery. Complication including index infection, recurrent infection or delaying union/nonunion will be identified at the time of diagnosis and/or during each participants assessment that occurs during routine outpatient clinic visit. Detailed information on the infection including date of diagnosis, participant signs and symptoms, culture test results, method of treatment(s), and date of resolution will be documented.
4/23/2020: Study recruitment temporarily halted due to COVID-19
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Open Fracture Cohort | – | Other: Immunofluorescence ImagingPatients 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. |
| Complication Cohort | – | Other: Immunofluorescence ImagingPatients 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 | – | Other: Immunofluorescence ImagingPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (20 listed)
- 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.
Key exclusion criteria (30 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immunofluorescence ImagingPatients 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. | Other | Closed Fracture Cohort, Complication Cohort, Open Fracture Cohort |
Primary outcome
Percent of Patients That Complete the Protocol
Time frame: 1 year
As this is a pilot and feasibility study, the outcome measure is the percent of patients that successfully complete the protocol.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ida L Gitajn, MD principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma Injury, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of Patients That Complete the Protocol (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.