Status:
RECRUITING
Near-Infrared Imaging for Perfusion Assessment of Traumatic Soft Tissue and Skeletal Injuries
Lead Sponsor:
Leiden University Medical Center
Collaborating Sponsors:
Erasmus Medical Center
Conditions:
Perfusion
Traumatic Injury
Eligibility:
All Genders
18+ years
Phase:
NA
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....
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 traumat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 10 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06034834
Start Date
November 13 2023
End Date
November 10 2025
Last Update
March 20 2024
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Leiden University Medical Center
Leiden, South Holland, Netherlands, 2333ZA
2
Erasmus University Medical Center
Rotterdam, South Holland, Netherlands, 3000 CA