Trauma InjuryNCT04927637
ICG 24h Prior to Operative Treatment of Orthopaedic Infection
An observational study of Trauma Injury and Bone Infection, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
The focus of this study is to (1) Explore variability in distribution of 24h ICG in bone and soft tissue infection (2) Evaluate the change in 24h ICG distribution from pre to post debridement (3) Preliminarily determine whether 24h ICG has the possibility predict infection / treatment failure. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Trauma Injury, Bone Infection
- What is being tested?
- imaging 24 hours following intravenous administration of ICG
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2021to 9 Mar 2024
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients over the age of 18 who have been diagnosed with an infection following orthopaedic trauma
Who may be able to join
- 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 planned SSI care surgeries performed by a participating surgeon or delegate.
- Provision of informed consent.
Who cannot join
- Fractures of the hand cannot be imaged.
- Iodine allergy.
- Burns at the SSI site.
- Incarceration.
- Expected survival of less than 90 days.
- Problems, in the judgment of study personnel, with maintaining follow-up with the patient.
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- Adults unable to consent or whom do not have a LAR
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03766
About this study
Official title: A Pilot Study to Evaluate Single Dose Indocyanine Green 24 Hours Prior to Operative Treatment of Orthopaedic Infection
The focus of this study is to (1) Explore variability in distribution of 24h ICG in bone and soft tissue infection (2) Evaluate the change in 24h ICG distribution from pre to post debridement (3) Preliminarily determine whether 24h ICG has the possibility predict infection / treatment failure. Patients will be administered a single, ICG, 2.5-5mg/kg dose 24 hours prior to surgery. The patient will be prepared and transported to surgery as per routine at Dartmouth-Hitchcock. ICG fluorescence images will be acquired prior to surgical debridement.
Read the detailed description
Infection following trauma is one of the most prevalent and challenging complications faced by orthopedic surgeons in both military and civilian populations, occurring after up to 60% of open bone fractures. Several factors specific to this trauma place patients at high risk for infectious complications, including: traumatized tissues, open contaminated fracture, soft tissue coverage issues, catabolic state due to poly-trauma, prolonged hospitalization with exposure to nosocomial bacteria, and presence of metallic implants8. Infection requires one or more unplanned surgical procedures and leads to prolonged morbidity, loss of function, and potential loss of limb. Failed treatment for bone infection results in recurrent infection, requiring repeat surgical procedures in approximately 30% of patients.
Infection is known to display the enhanced permeability and retention effect with increased vascular permeability. Second window or 24h ICG represents an ideal method to identify these areas of increased vascular permeability. In some instances infected tissue can be hard to distinguish from healthy tissue when ICG is given immediately before optical imaging Second window ICG will allow surgeons to better distinguish infected tissue from healthy tissue as the ICG will have a better opportunity to permeate the infected tissue while it will have been expelled from the health tissue.
There are currently no accepted intraoperative tools that can be used to make objective decisions about which bone and tissue is infected and which is normal. Methods currently used to guide debridement are quite rudimentary. Clinical judgment is based on the gross appearance of soft tissue and bone, including color, turgor, and extent of soft tissue stripping. A burr may be used to look for bleeding bone. More extensive debridement is thought to minimize risk of index infection or reduce the rate of persistent infection; however, this comes at the cost of increasingly complex reconstructive procedures to fill bony defects. Clearly what is needed is a functional imaging system which can identify infected tissues to guide surgeons in the amount of tissue to debride. In turn, this will lead to fewer infections and a more effective treatment of SSIs at the fracture site. Both scenarios will allow patients to return to duty or work sooner.
The study endpoint is to determine the variability of bone and soft tissue perfusion in infection patients when given a single dose of ICG 24h prior to surgical debridement. The long term goal of this study is to aid in the development and optimization of bone specific imaging strategies that can be used to guide debridement and to optimize the quality of bone / tissue resection to minimize complications.
- Conditions
- Trauma Injury, Bone Infection
- Being tested
- imaging 24 hours following intravenous administration of ICG
- Keywords
- ICG, Infection, Orthopedics, fluorescence imaging
- Medical subject headings
- Accidental Injuries, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
imaging 24 hours following intravenous administration of ICGProcedure or surgery
Patients will be administered a single, FDA approved, ICG, 2.5-5mg/kg dose 24 hours prior to surgery. ICG fluorescence images will be acquired By a FDA approved surgical imaging device prior to surgical debridement. The wound will be irrigated as per standard procedure and another ICG fluorescence image will be acquired. The need for repeat debridement or tissue cultures will be left up to the treating surgeon.
| Study group | Role | What they receive |
|---|---|---|
| Orthopedic Infection | Subjects who have undergone previous orthopaedic trauma surgery and have developed and infection will be assessed for protocol inclusion criteria. Patients who meet all inclusion criteria and no exclusion criteria will be administered a single dose 2.5-5 mg/kg ICG dose intravenously ideally 24h prior to surgical debridement. Fluorescent images will be obtained pre and post irrigation and debridement Receives: Procedure: imaging 24 hours following intravenous administration of ICG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study Design Feasibility for Preoperative ICG Perfusion Rate as a Predictability Factor for Infection: Measured as Percentage of Patients With Analyzable Data
This pilot study's objective is to preliminarily determine the study design feasibility of using a single dose of ICG given 24h preoperatively to predict recurrent infection/treatment failure. ICG Perfusion rates within the surgical site will be utilized to assess if there are any predictive measures that would indicate a higher risk of infection. Outcome measure is defined as the percentage of subjects with analyzable data.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study start13 Aug 2021
- Primary completion9 Mar 2023
- Study completion9 Mar 2024
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.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- 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
- NCT04927637
- Sponsor's protocol ID
- STUDY02000989
- Status last verified
- Feb 2025
- First submitted
- 9 Jun 2021
- Last updated
- 27 Feb 2025
- 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 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate Single Dose Indocyanine Green 24 Hours Prior to Operative Treatment of Orthopaedic Infection
- ClinicalTrials.gov ID
- NCT04927637
- Acronym / sponsor ID
- STUDY02000989
- Conditions
- Trauma Injury, Bone Infection
- Keywords
- ICG, Infection, Orthopedics, fluorescence imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- 13 Aug 2021 (actual)
- Primary completion
- 9 Mar 2023 (actual)
- Study completion
- 9 Mar 2024 (actual)
- First posted
- 16 Jun 2021 (actual)
- Results
- Posted 30 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The focus of this study is to (1) Explore variability in distribution of 24h ICG in bone and soft tissue infection (2) Evaluate the change in 24h ICG distribution from pre to post debridement (3) Preliminarily determine whether 24h ICG has the possibility predict infection / treatment failure. Patients will be administered a single, ICG, 2.5-5mg/kg dose 24 hours prior to surgery. The patient will be prepared and transported to surgery as per routine at Dartmouth-Hitchcock. ICG fluorescence images will be acquired prior to surgical debridement.
Detailed description
Infection following trauma is one of the most prevalent and challenging complications faced by orthopedic surgeons in both military and civilian populations, occurring after up to 60% of open bone fractures. Several factors specific to this trauma place patients at high risk for infectious complications, including: traumatized tissues, open contaminated fracture, soft tissue coverage issues, catabolic state due to poly-trauma, prolonged hospitalization with exposure to nosocomial bacteria, and presence of metallic implants8. Infection requires one or more unplanned surgical procedures and leads to prolonged morbidity, loss of function, and potential loss of limb. Failed treatment for bone infection results in recurrent infection, requiring repeat surgical procedures in approximately 30% of patients.
Infection is known to display the enhanced permeability and retention effect with increased vascular permeability. Second window or 24h ICG represents an ideal method to identify these areas of increased vascular permeability. In some instances infected tissue can be hard to distinguish from healthy tissue when ICG is given immediately before optical imaging Second window ICG will allow surgeons to better distinguish infected tissue from healthy tissue as the ICG will have a better opportunity to permeate the infected tissue while it will have been expelled from the health tissue.
There are currently no accepted intraoperative tools that can be used to make objective decisions about which bone and tissue is infected and which is normal. Methods currently used to guide debridement are quite rudimentary. Clinical judgment is based on the gross appearance of soft tissue and bone, including color, turgor, and extent of soft tissue stripping. A burr may be used to look for bleeding bone. More extensive debridement is thought to minimize risk of index infection or reduce the rate of persistent infection; however, this comes at the cost of increasingly complex reconstructive procedures to fill bony defects. Clearly what is needed is a functional imaging system which can identify infected tissues to guide surgeons in the amount of tissue to debride. In turn, this will lead to fewer infections and a more effective treatment of SSIs at the fracture site. Both scenarios will allow patients to return to duty or work sooner.
The study endpoint is to determine the variability of bone and soft tissue perfusion in infection patients when given a single dose of ICG 24h prior to surgical debridement. The long term goal of this study is to aid in the development and optimization of bone specific imaging strategies that can be used to guide debridement and to optimize the quality of bone / tissue resection to minimize complications.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Orthopedic Infection | – | Procedure: imaging 24 hours following intravenous administration of ICGSubjects who have undergone previous orthopaedic trauma surgery and have developed and infection will be assessed for protocol inclusion criteria. Patients who meet all inclusion criteria and no exclusion criteria will be administered a single dose 2.5-5 mg/kg ICG dose intravenously ideally 24h prior to surgical debridement. Fluorescent images will be obtained pre and post irrigation and debridement |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over the age of 18 who have been diagnosed with an infection following orthopaedic trauma
Key inclusion criteria (6 listed)
- 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 planned SSI care surgeries performed by a participating surgeon or delegate.
Key exclusion criteria (9 listed)
- Fractures of the hand cannot be imaged.
- Iodine allergy.
- Burns at the SSI site.
- Incarceration.
- Expected survival of less than 90 days.
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 |
|---|---|---|
| imaging 24 hours following intravenous administration of ICGPatients will be administered a single, FDA approved, ICG, 2.5-5mg/kg dose 24 hours prior to surgery. ICG fluorescence images will be acquired By a FDA approved surgical imaging device prior to surgical debridement. The wound will be irrigated as per standard procedure and another ICG fluorescence image will be acquired. The need for repeat debridement or tissue cultures will be left up to the treating surgeon. | Procedure or surgery | Orthopedic Infection |
Primary outcome
Study Design Feasibility for Preoperative ICG Perfusion Rate as a Predictability Factor for Infection: Measured as Percentage of Patients With Analyzable Data
Time frame: Baseline
This pilot study's objective is to preliminarily determine the study design feasibility of using a single dose of ICG given 24h preoperatively to predict recurrent infection/treatment failure. ICG Perfusion rates within the surgical site will be utilized to assess if there are any predictive measures that would indicate a higher risk of infection. Outcome measure is defined as the percentage of subjects with analyzable data.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- 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 and Bone Infection, 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 6 inclusion and 9 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 27 Feb 2025. 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 30 Jan 2025). 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?
Study Design Feasibility for Preoperative ICG Perfusion Rate as a Predictability Factor for Infection: Measured as Percentage of Patients With Analyzable Data (time frame: Baseline). 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 27 Feb 2025.