Using fluorescence imaging to improve surgical decisions for burn wounds
Fluorescence-based Detection of Inflammation and Necrosis to Inform Surgical Decision-making and Enhance Outcomes
This study is testing a new imaging technique to help doctors better identify damaged tissue in burn patients during surgery to improve healing and outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Wisconsin, Madison Academic / other |
| Locations | 1 site (Madison, Wisconsin) |
| Trial ID | NCT05593523 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of fluorescence image-guided surgery to accurately identify necrotic tissue in burn patients both before and during surgery. By employing a multi-modal approach, the study aims to optimize the use of Indocyanine Green (ICG) to enhance surgical decision-making and improve patient outcomes. The research will gather data to support a larger clinical trial focused on the feasibility and efficacy of this technology in improving necrosis detection and wound healing. Up to 100 participants will be involved over a period of approximately 24 days.
Who should consider this trial
Good fit: Ideal candidates include English-speaking patients with partial thickness burn wounds occurring within 24 hours of admission or those with deeper burns requiring surgery.
Not a fit: Patients with contraindications to ICG injection, pre-existing inflammatory diseases, or those unable to provide consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more precise surgical interventions and improved healing outcomes for burn patients.
How similar studies have performed: Previous studies using delayed imaging of high dose ICG have shown promise in other surgical contexts, suggesting potential success for this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Madison, Wisconsin
- University of Wisconsin — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Angela Gibson, MD, PHD — University of Wisconsin - Madison School of Medicine and Public Health
- Study coordinator: Adam Krajewski
- Email: krajewski@wisc.edu
- Phone: (608) 265-6460
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.