Near-Infrared Imaging for Perfusion Assessment of Traumatic Soft Tissue and Skeletal Injuries

NCT06034834 | Recruiting

• 1 other identifier: NL84014.058.23
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Perfusion; Traumatic Injury; Fluorescence Imaging

Keywords

Indocyanine Green; Near-infrared fluorescence imaging; Traumatic injuries; Perfusion

Outcome Measures

Primary Outcomes (1)

• Time-intensity curves

  The main endpoint of this study is an adequate time-intensity curve extracted from selected regions of interest. Adequate curves are defined as reproducible curves with accurate representation of the perfusion status. An adequate curve is characterized by a recognisable in- and outflow pattern representing the bloodflow in the tissue. Distinguishing between adequate, questionable and inadequate perfusion can only be done after comparing the measurement results.

  1 day

Secondary Outcomes (11)

• Maximum intensity (Imax)

  1 day

• Time till maximum intensity (Tmax)

  1 day

• The ingress rate and absolute slope

  1 day

• The normalized slope

  1 day

• The area's under the curve at 30, 60 and 120 seconds

  1 day

Study Arms (1)

Traumatic injuries

EXPERIMENTAL

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

Diagnostic Test: Near-infrared fluorescence imaging of perfusion

Interventions

Near-infrared fluorescence imaging of perfusion DIAGNOSTIC_TEST

Patients will undergo an intra-operative perfusion assessment using ICG NIR fluorescence imaging after clinical judgment and debridement of the traumatic injury. For patients undergoing additional debridement procedures, perfusion assessment with ICG will be repeated during every procedure.

Traumatic injuries

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Leiden University Medical Center: lead
• Erasmus Medical Center: collaborator

Study Sites (2)

Leiden University Medical Center

Leiden, South Holland, 2333ZA, Netherlands

RECRUITING

Erasmus University Medical Center

Rotterdam, South Holland, 3000 CA, Netherlands

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Stefan Koning, MD

  Leiden University Medical Center

  STUDY DIRECTOR

Central Study Contacts

Joost R van der Vorst, MD, PhD

CONTACT

+31715298528; j.r.van_der_vorst@lumc.nl

Inger B Schipper, Prof. MD, Phd

CONTACT

+31715265025; i.b.schipper@lumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The surgeons will be blinded as to the results of the intraoperative perfusion assessment in order to prevent bias.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. J. R. van der vorst, Vascular Surgeon

Model Details: 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 the treatment of patients.

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 13, 2023
• Study Start: November 13, 2023
• Primary Completion: September 10, 2025
• Study Completion: November 10, 2025
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2)