Detection and Delineation of Necrotizing Fasciitis Via a Vascular Perfusion Fluorophore: A Pilot Study

Status: Completed
Location: See location...
Intervention Type: Drug
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
New Hampshire
Dartmouth-Hitchock
Lebanon
Time Frame
Start Date: 2021-04-05
Completion Date: 2024-12-04
Participants
Target number of participants: 18
Treatments
Patients with possible nectrotizing fascitis
Patients with clinical suspicion of necrotizing fasciitis would receive a weight-appropriate IV dose of indocyanine green (ICG, FDA-approved) with immediate fluorescence imaging of the affected body part and simultaneous imaging of an unaffected region
Related Therapeutic Areas
Sponsors
Leads: Dartmouth-Hitchcock Medical Center

This content was sourced from clinicaltrials.gov