PerfusionIMPACTNCT06034834
Near-Infrared Imaging for Perfusion Assessment of Traumatic Soft Tissue and Skeletal Injuries
A study testing Near-infrared fluorescence imaging of perfusion in people with Perfusion and Traumatic Injury, run by Leiden University Medical Center at 2 sites in Netherlands.
Trial summary
To date, intraoperative assessment of tissue and bone viability is predominantly subjective, depending on the clinical view of the surgeon, resulting in a variation in the thoroughness of debridement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perfusion, Traumatic Injury, Fluorescence Imaging
- What is being tested?
- Near-infrared fluorescence imaging of perfusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesNetherlands
- Study dates
- 13 Nov 2023to 10 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- In order to be eligible to participate in this study, a subject must meet all the following criteria:
- Age ≥ 18 years
- Diagnosed with one or more of the following injuries:
- Crush injury
- Open deglovement
- Open fracture(s) (Gustilo 3, -A, -B \& -C)
Show all 9Show fewer
- Non-union tibia/clavicula/ulna/humerus/rib
- Fracture related infection
- Indication for surgical intervention
Who cannot join
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Hemodynamically unstable due to severe blood loss
- Allergic or hypersensitive to iodine/crustaceans/shellfish
- Diagnosed with endocrine thyroid disorders (hyperthyroidism)
- Pregnancy
- Diagnosed with impaired renal function eGFR <30 L/min/1.73m2
- Diagnosed with severely disturbed hepatic enzymes/liver failure
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites, 2 recruiting
- Recruiting
Leiden University Medical Center
Leiden, South Holland, 2333ZA
Joost R van der Vorst, MD, PhD, +3175298528, j.r.van_der_vorst@lumc.nl
Inger B Schipper, Prof. MD, PhD, +31715265025, i.b.schipper@lumc.nl
- Recruiting
Erasmus University Medical Center
Rotterdam, South Holland, 3000 CA
Mathieu M.E. Wijffels, MD, PhD, +3107032395, m.wijffels@erasmusmc.nl
About this study
To date, intraoperative assessment of tissue and bone viability is predominantly subjective, depending on the clinical view of the surgeon, resulting in a variation in the thoroughness of debridement. Inadequate initial resection leads to multiple debridement interventions, leading to prolonged hospitalization or readmission with consequently high direct medical costs.
Near-Infrared Fluorescence (NIRF) imaging with Indocyanine Green (ICG) could potentially be a relevant contribution to adequately treating soft tissue and skeletal injuries by creating an improved distinction between viable and non-viable tissue, based on perfusion indices.
This study evaluates whether intraoperative perfusion assessment with ICG fluorescence imaging is a feasible and quantifiable technique for treating traumatic injuries.
Read the detailed description
Rationale: In 2020 71.623 Dutch patients were acutely admitted to hospitals due to sustained traumatic injuries. 7% of the injuries related to open wounds and 44% to fractures. The majority of traumatic musculoskeletal injuries needs to be diagnosed and treated as soon as possible to lower the risk of infections and to minimize adverse outcome, such as necrosis and/or osteomyelitis. To date, intraoperative assessment of tissue and bone viability is predominantly subjective, resulting in a variation in thoroughness of debridement. If not all necrotic tissue is removed, suboptimal healing occurs, which serves as a potential food source for bacteria. In addition, inadequate initial resection leads to multiple debridement interventions, leading to prolonged hospitalization or readmission with consequently high direct medical costs. Since tissue necrosis is an ongoing process, radical resection of avital tissue during the initial procedure is not always possible. The surgeon's visual estimation is not optimal to predict the final amount of debridement. After maximal debridement, antibiotic treatment and coverage of open wounds, the incidence of infection can rise to 27%. Compromised perfusion is at the centre of this problem. An adequate blood supply is crucial for tissue viability and infection clearance.
Near-Infrared Fluorescence (NIRF) imaging with Indocyanine Green (ICG) has already shown its potential in effective real-time assessment of intra-operative tissue perfusion and the early prediction of future necrosis in multiple studies. This technique could potentially be a relevant contribution in adequately treating soft tissue and skeletal injuries by creating an improved distinction between viable and non-viable tissue, based on perfusion indices. However to date, the feasibility to quantify this technique in posttraumatic tissue has not been successfully evaluated.
Objective: The primary objective of this study is to evaluate the feasibility of Near-infrared Fluorescence (NIRF) imaging with Indocyanine green (ICG) to assess and quantify tissue perfusion in post-traumatic soft tissue and/or skeletal injury.
Study design: The study is a prospective observational multicentre pilot study. All included patients will undergo a perfusion assessment using ICG NIR fluorescence imaging. Perfusion assessment will not affect treatment of patients.
Study population: Patients aged 18 years or older with traumatic soft tissue and/or skeletal injury. Injuries included in the study are: open deglovement; crush injuries of extremities; open fractures, non-unions of clavicula, tibia, humerus, rib and/or ulna fractures and fracture related infections.
Intervention: Patients will undergo an intra-operative perfusion assessment using ICG NIR fluorescence imaging. For patients undergoing additional debridement procedures, perfusion assessment with ICG will be repeated during every procedure.
Main study parameters/endpoints: The primary outcome of this study is a time-intensity curve with quantified perfusion parameters in traumatic soft tissue and/or skeletal injuries. Perfusion parameters included in the analyses are time till maximum intensity (Tmax), maximum intensity (Imax) the ingress rate, the normalized slope, the absolute slope and the area under the curve at 30, 60 and 120 seconds.
- Conditions
- Perfusion, Traumatic Injury, Fluorescence Imaging
- Being tested
- Near-infrared fluorescence imaging of perfusion
- Keywords
- Indocyanine Green, Near-infrared fluorescence imaging, Traumatic injuries, Perfusion
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near-infrared fluorescence imaging of perfusionDiagnostic test
Patients will undergo an intra-operative perfusion assessment using ICG NIR fluorescence imaging after clinical judgment and debridement of the traumatic injury. For patients undergoing additional debridement procedures, perfusion assessment with ICG will be repeated during every procedure.
| Study group | Role | What they receive |
|---|---|---|
| Traumatic injuries | Experimental | Acute patients treated surgically for:
* Open deglovement (n=20)
* Crush injury (n=20)
* Open fractures (n=20)
The setting is defined acute when there is less than 24 hours between sustaining the injury and surgery.
Elective patients treated surgically for:
* Fracture related infection (FRI) (n=10)
* Non-union of fractures (n=50) Subdivided into 5 groups of 10.
* Elective osteosynthesis of non-union clavicula fracture N=10
* Primarily operated on N=5
* Primarily treated conservatively N=5
* Elective osteosynthesis of non-union tibia. N=10
* Elective osteosynthesis of non-union ulna. N=10
* Primarily operated on N=5
* Primarily treated conservatively N=5
* Elective osteosynthesis of non-union humerus. N=10
* Elective osteosynthesis of non-union of the rib. N=10 Receives: Diagnostic Test: Near-infrared fluorescence imaging of perfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-intensity curves
The main endpoint of this study is an adequate time-intensity curve extracted from selected regions of interest. Adequate curves are defined as reproducible curves with accurate representation of the perfusion status. An adequate curve is characterized by a recognisable in- and outflow pattern representing the bloodflow in the tissue. Distinguishing between adequate, questionable and inadequate perfusion can only be done after comparing the measurement results.
Measured: 1 day
Secondary outcomes (11)
Maximum intensity (Imax)
As secondary study parameters quantified perfusion parameters will be extracted from the time-intensity curves. The parameters extracted include:
- Maximum intensity (Imax) in arbitrary units (a.u.)
Measured: 1 day
Time till maximum intensity (Tmax)
As secondary study parameters quantified perfusion parameters will be extracted from the time-intensity curves. The parameters extracted include:
- Time till maximum intensity (Tmax), in seconds.
Measured: 1 day
The ingress rate and absolute slope
As secondary study parameters quantified perfusion parameters will be extracted from the time-intensity curves. The parameters extracted include:
- The ingress rate
- The absolute slope Both in arbitrary units per second (a.u./s)
Measured: 1 day
The normalized slope
As secondary study parameters quantified perfusion parameters will be extracted from the time-intensity curves. The parameters extracted include:
- The normalized slope in percentages per second (%/s)
Measured: 1 day
The area's under the curve at 30, 60 and 120 seconds
As secondary study parameters quantified perfusion parameters will be extracted from the time-intensity curves. The parameters extracted include:
- Area under the curve at 30, 60 and 120 seconds in percentages (%)
Measured: 1 day
Incidence of necrotic tissue
Perfusion parameters will be evaluated for their correlation with the occurrence of necrotic tissue after initial debridement.
This will be calculated as the percentage of people with inadequate perfusion parameters that develop necrotic tissue compared to people with adequate perfused tissue.
Measured: 90 days of necrotic
The amount of additional debridement procedures
The number of additional debridement procedures when comparing the group with inadequate perfused tissue to the group with adequate perfused tissue.
In numbers and percentages.
Measured: 90 days
The infection incidence
Perfusion parameters will be evaluated for their correlation with the occurrence of wound infection within 90 days after procedure. Infection defined as a red, swollen and painful area that is warm and tender to touch, possibly in combination with fever/chills, purulent effusion, positive cultures or increased infection parameters. The group with adequate perfused tissue will be compared to the group with inadequate perfusion.
This will be in numbers and percentages.
Measured: 90 days
The incidence of a fracture related infection
Incidence of a fracture related infection will be compared between the groups with adequate and inadequate perfusion in numbers and percentages.
Measured: 90 days
Lentgh of hospital stay
The length of hospital stay will be measured in days and compared between groups with adequate and inadequate perfusion.
Measured: 90 days
Amount of readmission
The number of readmissions within 90 days associated with complications of primary problem (infection, necrosis, death) will be compared between the groups with inadequate and adequate tissue perfusion in numbers and percentages.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start13 Nov 2023
- Primary completion10 Sep 2025 (estimated)
- Study completion10 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PerfusionStudies of the same condition, open and under way.
- More trials run by Leiden University 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study is a prospective observational multicentre pilot study. All included patients will undergo a perfusion assessment using ICG NIR fluorescence imaging. Perfusion assessment will not affect the treatment of patients.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Erasmus Medical Center
- Responsible party
- Principal investigator, Joost R. van der Vorst, MD, PhD, Leiden University Medical Center
- Investigators
- Stefan Koning, MD, Study director, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06034834
- Sponsor's protocol ID
- NL84014.058.23
- Acronym
- IMPACT
- Status last verified
- Mar 2024
- First submitted
- 29 Aug 2023
- Last updated
- 20 Mar 2024
- Results posted
- No
- 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 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Near-Infrared Imaging for Perfusion Assessment of Traumatic Soft Tissue and Skeletal Injuries
- ClinicalTrials.gov ID
- NCT06034834
- Acronym / sponsor ID
- IMPACT / NL84014.058.23
- Conditions
- Perfusion, Traumatic Injury, Fluorescence Imaging
- Keywords
- Indocyanine Green, Near-infrared fluorescence imaging, Traumatic injuries, Perfusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- Erasmus Medical Center
- Study start
- 13 Nov 2023 (actual)
- Primary completion
- 10 Sep 2025 (estimated)
- Study completion
- 10 Nov 2025 (estimated)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To date, intraoperative assessment of tissue and bone viability is predominantly subjective, depending on the clinical view of the surgeon, resulting in a variation in the thoroughness of debridement. Inadequate initial resection leads to multiple debridement interventions, leading to prolonged hospitalization or readmission with consequently high direct medical costs.
Near-Infrared Fluorescence (NIRF) imaging with Indocyanine Green (ICG) could potentially be a relevant contribution to adequately treating soft tissue and skeletal injuries by creating an improved distinction between viable and non-viable tissue, based on perfusion indices.
This study evaluates whether intraoperative perfusion assessment with ICG fluorescence imaging is a feasible and quantifiable technique for treating traumatic injuries.
Detailed description
Rationale: In 2020 71.623 Dutch patients were acutely admitted to hospitals due to sustained traumatic injuries. 7% of the injuries related to open wounds and 44% to fractures. The majority of traumatic musculoskeletal injuries needs to be diagnosed and treated as soon as possible to lower the risk of infections and to minimize adverse outcome, such as necrosis and/or osteomyelitis. To date, intraoperative assessment of tissue and bone viability is predominantly subjective, resulting in a variation in thoroughness of debridement. If not all necrotic tissue is removed, suboptimal healing occurs, which serves as a potential food source for bacteria. In addition, inadequate initial resection leads to multiple debridement interventions, leading to prolonged hospitalization or readmission with consequently high direct medical costs. Since tissue necrosis is an ongoing process, radical resection of avital tissue during the initial procedure is not always possible. The surgeon's visual estimation is not optimal to predict the final amount of debridement. After maximal debridement, antibiotic treatment and coverage of open wounds, the incidence of infection can rise to 27%. Compromised perfusion is at the centre of this problem. An adequate blood supply is crucial for tissue viability and infection clearance.
Near-Infrared Fluorescence (NIRF) imaging with Indocyanine Green (ICG) has already shown its potential in effective real-time assessment of intra-operative tissue perfusion and the early prediction of future necrosis in multiple studies. This technique could potentially be a relevant contribution in adequately treating soft tissue and skeletal injuries by creating an improved distinction between viable and non-viable tissue, based on perfusion indices. However to date, the feasibility to quantify this technique in posttraumatic tissue has not been successfully evaluated.
Objective: The primary objective of this study is to evaluate the feasibility of Near-infrared Fluorescence (NIRF) imaging with Indocyanine green (ICG) to assess and quantify tissue perfusion in post-traumatic soft tissue and/or skeletal injury.
Study design: The study is a prospective observational multicentre pilot study. All included patients will undergo a perfusion assessment using ICG NIR fluorescence imaging. Perfusion assessment will not affect treatment of patients.
Study population: Patients aged 18 years or older with traumatic soft tissue and/or skeletal injury. Injuries included in the study are: open deglovement; crush injuries of extremities; open fractures, non-unions of clavicula, tibia, humerus, rib and/or ulna fractures and fracture related infections.
Intervention: Patients will undergo an intra-operative perfusion assessment using ICG NIR fluorescence imaging. For patients undergoing additional debridement procedures, perfusion assessment with ICG will be repeated during every procedure.
Main study parameters/endpoints: The primary outcome of this study is a time-intensity curve with quantified perfusion parameters in traumatic soft tissue and/or skeletal injuries. Perfusion parameters included in the analyses are time till maximum intensity (Tmax), maximum intensity (Imax) the ingress rate, the normalized slope, the absolute slope and the area under the curve at 30, 60 and 120 seconds.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study is a prospective observational multicentre pilot study. All included patients will undergo a perfusion assessment using ICG NIR fluorescence imaging. Perfusion assessment will not affect the treatment of patients.
| Arm | Type | Receives |
|---|---|---|
| Traumatic injuries | Experimental | Diagnostic Test: Near-infrared fluorescence imaging of perfusionAcute patients treated surgically for: * Open deglovement (n=20) * Crush injury (n=20) * Open fractures (n=20) The setting is defined acute when there is less than 24 hours between sustaining the injury and surgery. Elective patients treated surgically for: * Fracture related infection (FRI) (n=10) * Non-union of fractures (n=50) Subdivided into 5 groups of 10. * Elective osteosynthesis of non-union clavicula fracture N=10 * Primarily operated on N=5 * Primarily treated conservatively N=5 * Elective osteosynthesis of non-union tibia. N=10 * Elective osteosynthesis of non-union ulna. N=10 * Primarily operated on N=5 * Primarily treated conservatively N=5 * Elective osteosynthesis of non-union humerus. N=10 * Elective osteosynthesis of non-union of the rib. N=10 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- In order to be eligible to participate in this study, a subject must meet all the following criteria:
- Age ≥ 18 years
- Diagnosed with one or more of the following injuries:
- Indication for surgical intervention
Key exclusion criteria (7 listed)
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Hemodynamically unstable due to severe blood loss
- Allergic or hypersensitive to iodine/crustaceans/shellfish
- Diagnosed with endocrine thyroid disorders (hyperthyroidism)
- Pregnancy
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 |
|---|---|---|
| Near-infrared fluorescence imaging of perfusionPatients will undergo an intra-operative perfusion assessment using ICG NIR fluorescence imaging after clinical judgment and debridement of the traumatic injury. For patients undergoing additional debridement procedures, perfusion assessment with ICG will be repeated during every procedure. | Diagnostic test | Traumatic injuries |
Primary outcome
Time-intensity curves
Time frame: 1 day
The main endpoint of this study is an adequate time-intensity curve extracted from selected regions of interest. Adequate curves are defined as reproducible curves with accurate representation of the perfusion status. An adequate curve is characterized by a recognisable in- and outflow pattern representing the bloodflow in the tissue. Distinguishing between adequate, questionable and inadequate perfusion can only be done after comparing the measurement results.
11 secondary outcomes
Maximum intensity (Imax)
Time frame: 1 day
Time till maximum intensity (Tmax)
Time frame: 1 day
The ingress rate and absolute slope
Time frame: 1 day
The normalized slope
Time frame: 1 day
The area's under the curve at 30, 60 and 120 seconds
Time frame: 1 day
Incidence of necrotic tissue
Time frame: 90 days of necrotic
The amount of additional debridement procedures
Time frame: 90 days
The infection incidence
Time frame: 90 days
The incidence of a fracture related infection
Time frame: 90 days
Lentgh of hospital stay
Time frame: 90 days
Amount of readmission
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- 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.
Stefan Koning, MD study director
Leiden University Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Near-infrared fluorescence imaging of perfusion in people with Perfusion and Traumatic Injury, run by Leiden University Medical Center at 2 sites in Netherlands.
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 9 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joost R van der Vorst, MD, PhD (+31715298528, j.r.van_der_vorst@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-intensity curves (time frame: 1 day). 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 20 Mar 2024.