Detection and Delineation of Necrotizing Fasciitis Via a Vascular Perfusion Fluorophore

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-05

Study Completion Date

2024-12-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Biomarkers in Patients With Flesh-eating Bacterial Infections

NCT02180906

Necrotizing Soft Tissue Infection Necrotizing Fasciitis Gas Gangrene +1 more

COMPLETED

Irrigating vs Traditional Negative Pressure Wound Therapy to Treat Necrotizing Soft Tissue Infections

NCT07120386

Necrotizing Soft Tissue Infections

RECRUITING NA

Evaluation of Fluorescence-image Guided Wound Assessment vs. Standard Practice

NCT02315092

Foot Ulcer, Diabetic Bacteria

COMPLETED

A Prospective Study of Endothelial Dysfunction and Diabetic Foot Ulcer Risk

NCT00013286

Diabetic Foot Ulcers

COMPLETED

Human and Bacterial Protease Activity As Prognostic Tool of Foot Infections in Diabetic Patients

NCT03964571

Diabetic Foot Infection

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 inoculation of extremely aggressive bacteria into the soft-tissues surrounding the fascial layer of connective tissue, just deep to the subcutaneous fat. This tissue layer provides an ideal environment for bacterial growth and also facilitates rapid advancement of the bacteria along the fascia. The result is a soft-tissue infection that often spreads centrally prior to detection and/or adequate management, leading to systemic sepsis, multi-organ failure, and death.

Further complicating NF management is that there is no definitive diagnostic test. Patients with NF present generally with pain, fever, and elevated inflammatory labs (white blood cell count (WBC), erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP)), other lab abnormalities (elevated glucose and creatinine; reduced sodium and hemoglobin); however, these are non-specific findings that are associated with numerous other-nonfatal-conditions. For this reason, a diagnosis of NF is often missed until the condition has progressed too far.

Medical fluorescence is a nascent form of medical imaging that seeks to improve the recognition of important anatomical structures and disease processes through machine-assisted, visual identification using fluorescent probes called fluorophores. Several types of fluorophores exist: targeted fluorophores, enzyme-activated fluorophores, and simple intravascular fluorophores.

Intravascular fluorophores, primarily indocyanine green (ICG), have been available for \~100 years. ICG is FDA approved and has an excellent safety record with no demonstrable toxicity. When injected intravenously and viewed with an appropriate fluorescence imager, ICG effectively maps out the local vasculature, enabling the viewer to distinguish perfused and non-perfused tissues. ICG's FDA-approved indications and uses include angiography to determine cardiac output, hepatic function, liver blood flow, and ophthalmic anatomy.

Upon histological examination of tissues affected by NF, there exist four commonly observed features: 1) the presence of bacteria; 2) robust neutrophil infiltration; 3) tissue necrosis; 4) vascular thrombosis. DH-H Department of Pathology currently reviews tissue biopsies with respect to these criteria when evaluating tissue for the presence of necrotizing fasciitis (Soloman et al, Modern Pathology, 2018, pp 546-552). While useful to guide clinical decision-making, histological review is not considered to be a definitive diagnostic finding, but these observations do have moderate sensitivity and specificity with culture data, which is considered to be the ultimate determinant of an NF diagnosis.

Because of the profound pro-thrombotic effects of necrotizing fasciitis within the subcutaneous tissues, we hypothesize that the 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. If we can demonstrate that ICG fluorescence voids are characteristic of NF, this could potentially lead to a more rapid, and potentially more accurate, diagnosis of NF that would lead to more rapid definitive management and-likely-improved outcomes.

The goal of this pilot study is to evaluate whether ICG fluorescence may be used as a non-invasive method of identifying the presence of NF.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Necrotising Fasciitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Indocyanine green solution

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Indocyanine green solution

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Age 18 years or older
2. 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
3. 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.
4. The ability to give written informed consent