Detection and Delineation of Necrotizing Fasciitis Via a Vascular Perfusion Fluorophore

NCT04839302 | Completed

• 1 other identifier: STUDY02000905
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

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

Conditions

Necrotising Fasciitis

Keywords

indocyanine green; Necrotising Fascitis

Outcome Measures

Primary Outcomes (1)

• Diagnosis of Necrotising Fascitis using indocyanine green

  Administration of ICG and subsequent imaging of a bodily region affected with NF will demonstrate substantially reduced fluorescence compared to the patient's unaffected tissues. Demonstration that ICG fluorescence voids are characteristic of NF.

  One Day

Study Arms (1)

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

Drug: Indocyanine green solution

Interventions

Indocyanine green solution DRUG

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

Patients with possible nectrotizing fascitis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects presenting to the Emergency Department (ED) with clinical suspicion for necrotizing fasciitis (history, exam, lab studies, imaging studies).

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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Hitchock

Lebanon, New Hampshire, 03766, United States

Location

Related Publications (3)

• Solomon IH, Borscheid R, Laga AC, Askari R, Granter SR. Frozen sections are unreliable for the diagnosis of necrotizing soft tissue infections. Mod Pathol. 2018 Apr;31(4):546-552. doi: 10.1038/modpathol.2017.173. Epub 2017 Dec 15.

  PMID: 29243739 BACKGROUND

• Betz CS, Zhorzel S, Schachenmayr H, Stepp H, Havel M, Siedek V, Leunig A, Matthias C, Hopper C, Harreus U. Endoscopic measurements of free-flap perfusion in the head and neck region using red-excited Indocyanine Green: preliminary results. J Plast Reconstr Aesthet Surg. 2009 Dec;62(12):1602-8. doi: 10.1016/j.bjps.2008.07.042. Epub 2008 Nov 25.

  PMID: 19036663 BACKGROUND

• Ray GS, Streeter SS, Bateman LM, Elliott JT, Henderson ER; NEFARIOUS Study Group. Real-time identification of life-threatening necrotizing soft-tissue infections using indocyanine green fluorescence imaging. J Biomed Opt. 2024 Jun;29(6):066003. doi: 10.1117/1.JBO.29.6.066003. Epub 2024 May 14.

  PMID: 38745983 DERIVED

MeSH Terms

Conditions

Fasciitis, Necrotizing

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases

Study Officials

• Eric R Henderson, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Orthopaedics

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 9, 2021
• Study Start: April 5, 2021
• Primary Completion: December 4, 2024
• Study Completion: December 4, 2024
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)