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

NCT05593523 | Active Not Recruiting FDA Drug FDA Device

• 4 other identifiers: 2022-10701R01GM145723-01Protocol Version 3/27/2025A539714
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

imaging; detection; necrosis

Outcome Measures

Primary Outcomes (6)

• Signal to Background Ratio (SBR) of ICGA and SWIG Fluorescence Images

  Quantitative assessment of all ICGA and SWIG fluorescence images will be achieved in part by measuring the fluorescence signal-to-background ratio (SBR).

  up to 96 hours after injury (up to 4 days on study)

• Standard Deviation of ICGA and SWIG Fluorescence Images

  Quantitative assessment of all ICGA and SWIG fluorescence images will be achieved in part by measuring the fluorescence standard deviation.

  up to 96 hours after injury (up to 4 days on study)

• Spatial Pattern of ICGA and SWIG Fluorescence Images

  Qualitative characterization of all ICGA and SWIG fluorescence images will be achieved by evaluating the fluorescence spatial patterns and features.

  up to 96 hours after injury (up to 4 days on study)

• Burn Surgeon Assessment of Wound Healing (Yes/No)

  For Aim 1, a burn surgeon blinded to the fluorescence data will perform an assessment of complete wound healing without surgery (Yes/No) at 21 ± 3 days from burn injury.

  up to 24 days from burn injury (up to 21 days on study)

• Burn Surgeon Assessment of Graft Loss (Yes/No)

  For Aim 2, a burn surgeon blinded to the fluorescence data will perform an assessment of presence or absence of graft loss (Yes/No) 14 ± 7 days after discharge following skin grafting.

  up to 21 days after discharge following skin grafting (up to 31 days on study)

• Depth of Necrotic Tissue as a Percentage of the Tissue Biopsy Thickness

  sample collected up to 4 days on study

Secondary Outcomes (1)

• Spatial Correlation of ICG fluorescence and Cell Necrosis and Inflammation

  sample collected up to 4 days on study

Study Arms (2)

Aim 1: Partial Thickness Burn Wounds

Participants with 1-30% total body surface area (TBSA) partial thickness burn wounds admitted to the University of Wisconsin (UW) Burn Center within 24 hours of burn injury and expected to be admitted for 3 days. Indocyanine green angiography (ICGA) fluorescence imaging immediately after administration of 7mg of ICG, and second window indocyanine green (SWIG) fluorescence imaging \~24 hours after administration of up to 5 mg/kg ICG of human burn wounds. ICGA within 72 hours of admission with the OnLume Clinical Imaging System (CIS). SWIG fluorescence imaging will also be performed perioperatively if applicable.

Drug: Indocyanine green (ICG); Device: Clinical Fluorescence Imaging Device

Aim 2: Deep Partial or Full Thickness Burn Wounds

Participants with 1-30% total body surface area (TBSA) deep partial or full thickness burn wounds that will likely require surgery. ICGA fluorescence imaging immediately after administration of 7mg of ICG, and second window indocyanine green (SWIG) fluorescence imaging \~24 hours after administration of up to 5 mg/kg ICG of human burn wounds. Imaging will occur with the OnLume Clinical Imaging System (CIS).

Drug: Indocyanine green (ICG); Device: Clinical Fluorescence Imaging Device

Interventions

Clinical Fluorescence Imaging Device 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)

Also known as: Asimov-MSK Imaging System, OnLume, SPY Elite, SPY-PHI, EleVision IR, VS3-IR

Aim 1: Partial Thickness Burn Wounds; Aim 2: Deep Partial or Full Thickness Burn Wounds

Indocyanine green (ICG) DRUG

ICG is a well, known, FDA-approved dye

Aim 1: Partial Thickness Burn Wounds; Aim 2: Deep Partial or Full Thickness Burn Wounds

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Aim 1: Human subjects with partial thickness burn wounds admitted to the UW Burn Center within 24 hours of burn injury and expected to be admitted for 3 days Aim 2: Human subjects with 1-30% total body surface area (TBSA) deep partial or full thickness burn wounds that require surgery.

You may qualify if:

• English speaker
• Patients with partial thickness indeterminate depth burn wounds that occurred within 24 hours of admission and are expected to require admission for at least 3 days (Aim 1) or with deep partial thickness or full thickness burn wounds that are 1-30% TBSA and will likely require surgery (Aim 2)
• Subject understands the study procedures and can provide informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator

You may not qualify if:

• Contraindication to Indocyanine Green (ICG) injection, i.e. previous reaction to ICG (adverse event rate: 1 in 42,000) or Iodine allergy.
• Inability to obtain consent
• Subject with pre-existing inflammatory diseases or chronically treated before admission to the hospital with steroids or nonsteroidal anti-inflammatory drugs or biologics
• Subject with immune deficiency (HIV infection or use of corticosteroids, cytostatic drugs, tetracycline and certain bisphosphonates)
• Subject with known or suspected infections or on antibiotic therapy
• Subject known or suspected to be pregnant

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Related Publications (1)

• Junak M, Garcia H, Liu A, Donahue B, Pashaj J, Zajac J, Uselmann A, Faucher L, Pogue BW, Gibson A. Evaluation of Burn Depth using Indocyanine Green: Discrepancies Between Macroscopic Visualization and the Microenvironment. Plast Reconstr Surg. 2026 Mar 10:10.1097/PRS.0000000000013011. doi: 10.1097/PRS.0000000000013011. Online ahead of print.

  PMID: 41805739 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

For Cohort 1, involving subjects with partial thickness burns, one 4 mm tissue biopsy (optional) will be collected from the center of the burn wound after SWIG imaging is performed. Optional blood draw for research purposes. For Cohort 2, up to two biopsies, one from the center of the burn wound and the other from a secondary location also within the tissue to be excised, will be taken at the time of surgery, or on the day of planned surgery in the event surgery was canceled due to unexpected healing (optional biopsy). Optional blood draw for research purposes.

MeSH Terms

Conditions

Burns; Necrosis

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Angela Gibson, MD, PHD

  University of Wisconsin - Madison School of Medicine and Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: October 25, 2022
• Study Start: March 9, 2023
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)