Burn WoundNCT05593523
Fluorescence-based Detection of Inflammation and Necrosis to Inform Surgical Decision-making and Enhance Outcomes
An observational study of Burn Wound, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burn Wound
- What is being tested?
- Indocyanine green (ICG) and Clinical Fluorescence Imaging Device
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2023to Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Tissue necrosis is a form of cell death caused by a wide variety of diseases and injuries. Current methods of detecting tissue necrosis to guide surgical decision making are limited. In burn injury, clinical visualization of tissue necrosis is the standard of care; however, it is an imprecise method that can result in delays in care, unnecessary surgery, and removal of viable tissue. There is a critical need to identify novel methods to improve the detection of necrosis in burn injury to aid perioperative clinical decision making. While Indocyanine Green Angiography (ICGA) has been shown to identify burn depth using perfusion as a surrogate marker for necrosis, it has not been widely adopted for clinical decision making. Recently, clinical trials using delayed imaging of high dose ICG (Second Window Indocyanine Green - SWIG) have shown promise in image-guided surgical resection of tumors. The investigators propose that SWIG imaging can be employed to enhance surgical decision-making in burn injury, as well as in many disease processes involving necrosis. The knowledge gained from this project will fill the critical need to prevent unnecessary surgery, improve surgical precision, and provide insight into ICG localization in inflamed and necrotic tissue.
The goal of this project is to characterize the SWIG fluorescence in burn inflammation and necrosis on a macroscopic and microscopic level.
Cohort 1 - The investigators will characterize fluorescent signals from SWIG in the healing potential of indeterminate depth burns in humans.
Cohort 2 - The investigators will examine the association between SWIG fluorescence and depth of necrosis in surgically excised burns, and in cases where surgery is canceled due to unexpected healing, in human subjects.
This project will result in clinical data testing of ICG for direct detection of necrotic tissue using a fluorescence imaging device optimized for burn surgery, while developing a platform for quantification of tissue necrosis and characterization of ICG-avid necrosis. These studies will provide necessary data to inform the design of a larger clinical trial to determine the efficacy and validity of ICG fluorescence-guided clinical decision making to improve outcomes for burn patients.
- Conditions
- Burn Wound
- Being tested
- Indocyanine green (ICG), Clinical Fluorescence Imaging Device
- Keywords
- imaging, detection, necrosis
- Medical subject headings
- Burns, Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine green (ICG)Drug
ICG is a well, known, FDA-approved dye
Clinical Fluorescence Imaging DeviceDevice
Also called Asimov-MSK Imaging System, OnLume, SPY Elite, SPY-PHI
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Drug: Indocyanine green (ICG); Device: Clinical Fluorescence Imaging Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: sample collected up to 4 days on study
Secondary outcomes (1)
Spatial Correlation of ICG fluorescence and Cell Necrosis and Inflammation
Measured: sample collected up to 4 days on study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2022
- Study start9 Mar 2023
- Primary completionMar 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Burn WoundStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
- Investigators
- Angela Gibson, MD, PHD, Principal investigator, University of Wisconsin - Madison School of Medicine and Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05593523
- Sponsor's protocol ID
- 2022-1070
- Other IDs
- 1R01GM145723-01, Protocol Version 3/27/2025, A539714
- Status last verified
- Apr 2026
- First submitted
- 20 Oct 2022
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 41805739
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluorescence-based Detection of Inflammation and Necrosis to Inform Surgical Decision-making and Enhance Outcomes
- ClinicalTrials.gov ID
- NCT05593523
- Acronym / sponsor ID
- 2022-1070
- Conditions
- Burn Wound
- Keywords
- imaging, detection, necrosis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 9 Mar 2023 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 25 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Tissue necrosis is a form of cell death caused by a wide variety of diseases and injuries. Current methods of detecting tissue necrosis to guide surgical decision making are limited. In burn injury, clinical visualization of tissue necrosis is the standard of care; however, it is an imprecise method that can result in delays in care, unnecessary surgery, and removal of viable tissue. There is a critical need to identify novel methods to improve the detection of necrosis in burn injury to aid perioperative clinical decision making. While Indocyanine Green Angiography (ICGA) has been shown to identify burn depth using perfusion as a surrogate marker for necrosis, it has not been widely adopted for clinical decision making. Recently, clinical trials using delayed imaging of high dose ICG (Second Window Indocyanine Green - SWIG) have shown promise in image-guided surgical resection of tumors. The investigators propose that SWIG imaging can be employed to enhance surgical decision-making in burn injury, as well as in many disease processes involving necrosis. The knowledge gained from this project will fill the critical need to prevent unnecessary surgery, improve surgical precision, and provide insight into ICG localization in inflamed and necrotic tissue.
The goal of this project is to characterize the SWIG fluorescence in burn inflammation and necrosis on a macroscopic and microscopic level.
Cohort 1 - The investigators will characterize fluorescent signals from SWIG in the healing potential of indeterminate depth burns in humans.
Cohort 2 - The investigators will examine the association between SWIG fluorescence and depth of necrosis in surgically excised burns, and in cases where surgery is canceled due to unexpected healing, in human subjects.
This project will result in clinical data testing of ICG for direct detection of necrotic tissue using a fluorescence imaging device optimized for burn surgery, while developing a platform for quantification of tissue necrosis and characterization of ICG-avid necrosis. These studies will provide necessary data to inform the design of a larger clinical trial to determine the efficacy and validity of ICG fluorescence-guided clinical decision making to improve outcomes for burn patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aim 1: Partial Thickness Burn Wounds | – | Drug: Indocyanine green (ICG), Device: Clinical Fluorescence Imaging DeviceParticipants 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. |
| Aim 2: Deep Partial or Full Thickness Burn Wounds | – | Drug: Indocyanine green (ICG), Device: Clinical Fluorescence Imaging DeviceParticipants 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indocyanine green (ICG)ICG is a well, known, FDA-approved dye | Drug | Aim 1: Partial Thickness Burn Wounds, Aim 2: Deep Partial or Full Thickness Burn Wounds |
| Clinical Fluorescence Imaging DeviceAlso: Asimov-MSK Imaging System, OnLume, SPY Elite, SPY-PHIOnLume 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) | Device | Aim 1: Partial Thickness Burn Wounds, Aim 2: Deep Partial or Full Thickness Burn Wounds |
Primary outcome
Signal to Background Ratio (SBR) of ICGA and SWIG Fluorescence Images
Time frame: up to 96 hours after injury (up to 4 days on study)
Quantitative assessment of all ICGA and SWIG fluorescence images will be achieved in part by measuring the fluorescence signal-to-background ratio (SBR).
Standard Deviation of ICGA and SWIG Fluorescence Images
Time frame: up to 96 hours after injury (up to 4 days on study)
Quantitative assessment of all ICGA and SWIG fluorescence images will be achieved in part by measuring the fluorescence standard deviation.
Spatial Pattern of ICGA and SWIG Fluorescence Images
Time frame: up to 96 hours after injury (up to 4 days on study)
Qualitative characterization of all ICGA and SWIG fluorescence images will be achieved by evaluating the fluorescence spatial patterns and features.
Burn Surgeon Assessment of Wound Healing (Yes/No)
Time frame: up to 24 days from burn injury (up to 21 days on study)
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.
Burn Surgeon Assessment of Graft Loss (Yes/No)
Time frame: up to 21 days after discharge following skin grafting (up to 31 days on study)
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.
Depth of Necrotic Tissue as a Percentage of the Tissue Biopsy Thickness
Time frame: sample collected up to 4 days on study
1 secondary outcome
Spatial Correlation of ICG fluorescence and Cell Necrosis and Inflammation
Time frame: sample collected up to 4 days on study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Derived from this study: PubMed 41805739Junak 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angela Gibson, MD, PHD principal investigator
University of Wisconsin - Madison School of Medicine and Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Burn Wound, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Signal to Background Ratio (SBR) of ICGA and SWIG Fluorescence Images (time frame: up to 96 hours after injury (up to 4 days on study)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05593523, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.