Near-Infrared Imaging for Perfusion Assessment of Traumatic Soft Tissue and Skeletal Injuries
Trial Parameters
Brief 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. 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.
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