Fluorescence-based Detection of Inflammation and Necrosis to Inform Surgical Decision-making and … (NCT05593523) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Fluorescence-based Detection of Inflammation and Necrosis to Inform Surgical Decision-making and Enhance Outcomes
United States100 participantsStarted 2023-03-09
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Signal to Background Ratio (SBR) of ICGA and SWIG Fluorescence Images
Timeframe: up to 96 hours after injury (up to 4 days on study)
2
Standard Deviation of ICGA and SWIG Fluorescence Images
Timeframe: up to 96 hours after injury (up to 4 days on study)
3
Spatial Pattern of ICGA and SWIG Fluorescence Images
Timeframe: up to 96 hours after injury (up to 4 days on study)
4
Burn Surgeon Assessment of Wound Healing (Yes/No)
Timeframe: up to 24 days from burn injury (up to 21 days on study)
5
Burn Surgeon Assessment of Graft Loss (Yes/No)
Timeframe: up to 21 days after discharge following skin grafting (up to 31 days on study)
6
Depth of Necrotic Tissue as a Percentage of the Tissue Biopsy Thickness