Detection and Delineation of Necrotizing Fasciitis Via a Vascular Perfusion Fluorophore

Completed

Conditions studied: Necrotising Fasciitis

In brief

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.

Key facts

Study ID

NCT04839302

Run by

Dartmouth-Hitchcock Medical Center

People needed

18

Starts

2021-04-05

Expected to finish

2024-12-04

Last updated by the study team

2025-05-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• Dartmouth-Hitchock — Lebanon, New Hampshire, United States

Full record on ClinicalTrials.gov

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