Using Near-Infrared Imaging to Assess Blood Flow in Traumatic Injuries
Near-Infrared Imaging for Perfusion Assessment of Traumatic Soft Tissue and Skeletal Injuries
NA · Leiden University Medical Center · NCT06034834
This study is testing a new imaging technique to help surgeons see blood flow in injured tissues during surgery, aiming to improve treatment for patients with traumatic injuries.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Leiden University Medical Center (other) |
| Locations | 2 sites (Leiden, Zuid-Holland and 1 other locations) |
| Trial ID | NCT06034834 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility of using Near-Infrared Fluorescence (NIRF) imaging with Indocyanine Green (ICG) to assess tissue and bone viability during surgery for traumatic injuries. By providing a quantifiable measure of perfusion, the study aims to improve the accuracy of debridement procedures, potentially reducing the need for multiple surgeries and associated hospital stays. The approach addresses the limitations of subjective visual assessments currently used by surgeons, which can lead to inadequate treatment and increased risk of complications. The study will involve patients diagnosed with specific traumatic injuries who require surgical intervention.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with specific traumatic injuries requiring surgical intervention.
Not a fit: Patients who are hemodynamically unstable, allergic to iodine, or have severe renal or liver dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better surgical outcomes and reduced hospital costs for patients with traumatic injuries.
How similar studies have performed: Other studies have shown promise in using NIRF imaging for similar applications, indicating a potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Leiden, Zuid-Holland and 1 other locations
- Leiden University Medical Center — Leiden, Zuid-Holland, Netherlands (RECRUITING)
- Erasmus University Medical Center — Rotterdam, Zuid-Holland, Netherlands (RECRUITING)
Study contacts
- Study coordinator: Joost R van der Vorst, MD, PhD
- Email: j.r.van_der_vorst@lumc.nl
- Phone: +31715298528
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Perfusion, Traumatic Injury, Fluorescence Imaging, Indocyanine Green, Near-infrared fluorescence imaging, Traumatic injuries