Real-Time Diagnosis of Life-Threatening Necrotizing Soft Tissue Infections Using Indocyanine Green Kinetic Modeling

The Nefarious Study Group

Study Overview

This study employs a prospective, non-randomized, observational design to determine if fluorescence signal contrast changes from indocyanine green (ICG) are associated with the presence of necrotizing soft tissue infection (NSTI) in a large patient population over a broad geographic area. The study will also investigate if NSTI-associated ICG fluorescence changes vary with different causative bacteria, particularly bacteria other than Group A Streptococcus, the main causative pathogen of NSTIs.

Inclusion Criteria

  • Age ≥ 18 years
  • Clinical suspicion of NSTI based on the local standard of care warranting:
  • Hospital admission for observation due to suspected NSTI; and/or
  • Soft tissue biopsy to rule in/out suspected NSTI; and/or
  • Surgical debridement for suspected NSTI; and/or
  • Specific institutional threshold criteria for triggering NSTI work-up; and
  • Ability to give written informed consent
Exclusion Criteria

  • History of allergy to ICG and/or iodine
  • Pregnant women or nursing mothers
  • While considered SOC, please ensure that patients have a pregnancy test administered
  • Prisoners

Site Enrollments

Dartmouth Health8
Emory University/
Grady Memorial0
University of California,
Los Angeles0
Stanford University0
University of Pittsburgh0
Vanderbilt University 0
University of Michigan0
University of Pennsylvania0