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ACTIVE NOT RECRUITING
NCT05593523

Fluorescence-based Detection of Inflammation and Necrosis to Inform Surgical Decision-making and Enhance Outcomes

Sponsor: University of Wisconsin, Madison

View on ClinicalTrials.gov

Summary

This study investigates fluorescence image-guided surgery to allow precise identification of necrotic tissue both preoperatively and intraoperatively in burn patients. Furthermore, it uses a multi-model approach to elucidate the localization of ICG in inflammation and necrosis to determine how this novel use of a well-known fluorescence marker can be optimized to aid in surgical decision making. This proposal will provide the necessary data to support the design of a larger clinical trial to study the feasibility and efficacy of this technology to improve the precision of necrosis detection and removal and improve wound healing outcomes. Up to 100 participants will be on study for up to approximately 24 days.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2023-03-09

Completion Date

2028-03

Last Updated

2025-12-17

Healthy Volunteers

No

Conditions

Interventions

DRUG

Indocyanine green (ICG)

ICG is a well, known, FDA-approved dye

DEVICE

Clinical Fluorescence Imaging Device

OnLume Clinical Imaging System or Commercially-available FDA approved clinical fluorescence imaging device (SPY Elite fluorescence imaging system, SPY-PHI portable handheld imaging system, or EleVision IR platform (also known as VS3-IR system)

Locations (1)

University of Wisconsin

Madison, Wisconsin, United States