Status:
COMPLETED
Detection and Delineation of Necrotizing Fasciitis Via a Vascular Perfusion Fluorophore
Lead Sponsor:
Dartmouth-Hitchcock Medical Center
Conditions:
Necrotising Fasciitis
Eligibility:
All Genders
18+ years
Brief Summary
The primary objective of this work is to determine if fluorescence signal intensity changes from a vascular perfusion fluorophore (indocyanine green) can be associated with the presence of necrotizing...
Detailed Description
Necrotizing fasciitis (NF)-commonly known as 'flesh-eating bacteria'-is an aggressive soft-tissue infection that has a high mortality rate (30-50%). NF is generally associated with traumatic inoculati...
Eligibility Criteria
Inclusion
- Age 18 years or older
- Clinical suspicion of necrotizing fasciitis based on physician or mid-level provider assessment. Clinical suspicion would be based upon the presence of one or more of these findings: Pain out of proportion to visible findings Temperature 100.4 F LRINEC (Laboratory Risk INdicator for NECrotizing fasciitis) score of ≥6 (https://pubmed.ncbi.nlm.nih.gov/15241098/) Tense soft tissues
- Determined to be a candidate for soft-tissue biopsy and/or surgical debridement by the on-call emergency department, orthopaedic, and/or general surgical trauma teams.
- The ability to give written informed consent
Exclusion
- History of allergy to ICG and/or iodine
- Pregnant women or nursing mothers
- No comparator region available for imaging control
Key Trial Info
Start Date :
April 5 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 4 2024
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04839302
Start Date
April 5 2021
End Date
December 4 2024
Last Update
May 23 2025
Active Locations (1)
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1
Dartmouth-Hitchock
Lebanon, New Hampshire, United States, 03766