Clinical Trials Logo

Clinical 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. 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT06034834
Study type Interventional
Source Leiden University Medical Center
Contact Joost R van der Vorst, MD, PhD
Phone +31715298528
Email j.r.van_der_vorst@lumc.nl
Status Recruiting
Phase N/A
Start date November 13, 2023
Completion date November 10, 2025

See also
  Status Clinical Trial Phase
Recruiting NCT04992130 - Sport Concussion Performance-Based Prevention Program N/A
Recruiting NCT05451394 - Prevention of Injury in Military Settings Through the Use of Body Awareness. N/A
Withdrawn NCT03928015 - Evaluation of Dronabinol For Acute Pain Following Traumatic Injury Phase 2
Recruiting NCT04588311 - ErythroPOietin Alfa to Prevent Mortality and Reduce Severe Disability in Critically Ill TRAUMA Patients Phase 3
Recruiting NCT05437575 - Prehospital Analgesia INtervention Trial (PAIN) Phase 3
Recruiting NCT05568888 - Evaluation of BE1116 in Patients With Traumatic Injury and Acute Major Bleeding to Improve Survival ( TAP Study ) Phase 3
Completed NCT02412982 - Evaluation of Venous Thromboembolism Prevention in High-Risk Trauma Patients Phase 4
Withdrawn NCT01497678 - Musculotendinous Tissue Unit Repair and Reinforcement (MTURR) Coordinating Center N/A
Completed NCT05225441 - National Investigation in College and High School Among Adolescents on Health and Substances at the FSEF
Completed NCT03927729 - Use of Methoxyflurane (Penthrox) as an Antalgic in Hospital Trauma N/A
Not yet recruiting NCT06383650 - Use of 81 vs 325mg of ASA in Treatment of BCVI Early Phase 1
Not yet recruiting NCT06366282 - Pediatric and Caregiver Traumatic Stress Intervention (PACTS) N/A
Completed NCT04778332 - Trottinettes Urgences 2019-2020
Recruiting NCT06404177 - Enantyum® IV Versus Piroxen® IM in Emergency Pain Management Phase 3
Recruiting NCT05086757 - Evaluation of Trauma Center-Based Intervention for Adolescent Traumatic Injury Survivors N/A
Completed NCT03628846 - Opioid Use After Traumatic Injury in Adolescents
Active, not recruiting NCT05320445 - A Psychosocial Transitional Group to Improve Adaptation, Coping and Mental Health Outcomes Following Trauma N/A
Completed NCT01771055 - Direct Peritoneal Resuscitation Effects in the Damage Control Patient N/A
Completed NCT01485419 - Characterization of the Early Sex Hormone Milieu Post Injury and Relationship With Resuscitation Requirements and Coagulopathy N/A
Completed NCT04980937 - Peroneal Nerve Injury: a 20- Year Retrospective Case Series Study