Condition: Necrotizing Fascitis · Sponsor: Eric R. Henderson
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-year safety record for vascular perfusion assessment. A distinguishing histological feature of NSTIs is prominent blood vessel thrombosis in affected tissues. Leveraging these pro-thrombotic effects, our study group has demonstrated in a first-in-human study (NCT04839302) that intravenous administration of ICG and immediate fluorescence imaging reveals prominent signal deficits in NSTI-positive tissues that differentiate significantly with increased signal seen with more common-and less virulent-infections such as cellulitis. We seek now to evaluate this imaging technique on a broader scale and d…
This description comes directly from the study's public registry record.
Eric R Henderson, MD · 603-650-5133 · Eric.R.Henderson@hitchcock.org
Morgan T Mazanec, MPH · 603-308-9233 · Morgan.T.Mazanec@Hitchcock.ORG
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| University of California, Los Angeles | Los Angeles, California, United States | Not Yet Recruiting |
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| Emory University/Grady Memorial Hospital | Atlanta, Georgia, United States | Recruiting |
| University of Michigan | Ann Arbor, Michigan, United States | Recruiting |
| Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire, United States | Recruiting |
| University of Pennsylvania | Philadelphia, Pennsylvania, United States | Recruiting |
| University of Pittsburgh Medical Center | Pittsburgh, Pennsylvania, United States | Not Yet Recruiting |
| Vanderbilt University | Nashville, Tennessee, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06877793