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

Launched by ERIC R. HENDERSON · Mar 10, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to quickly and accurately diagnose a serious infection known as necrotizing soft tissue infection (NSTI), often referred to as "flesh-eating bacteria." NSTIs can rapidly worsen and lead to severe health problems or even death, making early diagnosis crucial. The researchers are testing a technique that uses a special dye called indocyanine green (ICG) to help doctors see signs of this infection more clearly during imaging. By comparing the patterns of ICG fluorescence in infected tissues to those in less severe infections, the team hopes to improve how quickly and accurately NSTIs can be identified.

To participate in this trial, individuals must be at least 18 years old and have a clinical suspicion of NSTI that requires hospital admission, a biopsy, or surgery. Participants will receive the ICG dye and undergo imaging, but this process will not delay their standard medical care. The study is being conducted at eight major medical centers across the United States, and the findings could lead to a new method that enhances patient outcomes by reducing complications and improving survival rates for those with NSTIs.

Gender

ALL

Eligibility criteria

• 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.