CompletedNot Applicable

Detection and Delineation of Necrotizing Fasciitis Via a Vascular Perfusion Fluorophore

United States18 participantsStarted 2021-04-05

Plain-language 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 fasciitis. Hypothesis - Tissue regions affected with necrotizing fasciitis will demonstrate reduced fluorescence intensity compared to an unaffected region without clinical evidence of necrotizing fasciitis.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. History of allergy to ICG and/or iodine
✕. Pregnant women or nursing mothers
✕. No comparator region available for imaging control

What they're measuring

Diagnosis of Necrotising Fascitis using indocyanine green

Timeframe: One Day

Trial details

NCT IDNCT04839302

SponsorDartmouth-Hitchcock Medical Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-12-04

View on ClinicalTrials.gov More Necrotising Fasciitis trials