Near-Infrared Imaging for Perfusion Assessment of Traumatic Soft Tissue and Skeletal Injuries (IMPACT)
Perfusion, Traumatic Injury, Fluorescence Imaging
About this trial
This is an interventional diagnostic trial for Perfusion focused on measuring Indocyanine Green, Near-infrared fluorescence imaging, Traumatic injuries, Perfusion
Eligibility Criteria
Inclusion Criteria: 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) Non-union tibia/clavicula/ulna/humerus/rib Fracture related infection Indication for surgical intervention Exclusion Criteria: 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
Sites / Locations
- Leiden University Medical Center
- Erasmus University Medical Center
Arms of the Study
Arm 1
Experimental
Traumatic injuries
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