MedTrace Logo

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

NCT05593523 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2026-04-13

No results posted yet for this study

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.

Conditions

  • Burn Wound

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)

Sponsors & Collaborators

  • National Institute of General Medical Sciences (NIGMS)

    collaborator NIH

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • Angela Gibson, MD, PHD · University of Wisconsin - Madison School of Medicine and Public Health

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-09
Primary Completion
2027-03-31
Completion
2028-03-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05593523 on ClinicalTrials.gov