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Real-Time Diagnosis of Life-Threatening Necrotizing Soft Tissue Infections (NSTI) Using Indocyanine Green (ICG) Kinetic Modeling

Recruitingn/aAges 18 Years - anyAllEric R. Henderson
NCT06877793 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Necrotizing soft-tissue infections (NSTIs, a.k.a. "necrotizing fasciitis" or "flesh-eating bacteria") are aggressive infections that can progress rapidly from mild symptoms to sepsis, multi-organ failure, and death. NSTI cases present with non-specific clinical, imaging, and laboratory findings, and standard-of-care techniques for NSTI diagnosis lack sensitivity and specificity, resulting in frequent misdiagnosis and delayed care, which is the single most important predictor of survival. Consequently, the cumulative mortality rate for patients with NSTIs is 20- 30%; a dire need exists for more accurate and rapid detection of NSTIs. Fluorescence-guided surgery is a nascent technology seeking to improve the recognition of anatomical structures and disease processes using fluorescent probes (fluorophores). Indocyanine green (ICG) is an FDA-approved, near-infrared fluorophore with a \>60-yea

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥18 years. * Clinical suspicion of NSTI based on the local standard of care warranting: * Hospital admission for observation due to suspected NSTI; and/or * Soft tissue biopsy to rule in/out suspected NSTI; and/or * Surgical debridement for suspected NSTI; and/or * Specific institutional threshold criteria for triggering NSTI work-up; and * Ability to give written informed consent. Exclusion Criteria: * History of allergy to ICG and/or iodine. * Pregnant women or nursing mothers.
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What it tests

  • Administration of indocyanine green (ICG) and fluorescence imaging
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Where

8 sites
University of California, Los Angeles
Los Angeles, United States
Stanford University
Stanford, United States
Emory University/Grady Memorial Hospital
Atlanta, United States
University of Michigan
Ann Arbor, United States
Dartmouth-Hitchcock Medical Center
Lebanon, United States
University of Pennsylvania
Philadelphia, United States
University of Pittsburgh Medical Center
Pittsburgh, United States
Vanderbilt University
Nashville, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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