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

Status: Recruiting
Location: See location...
Intervention Type: Device, Drug
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Wisconsin
University of Wisconsin
RECRUITING
Madison
Contact Information
Primary
Adam Krajewski
krajewski@wisc.edu
(608) 265-6460
Time Frame
Start Date: 2023-03-09
Estimated Completion Date: 2028-03
Participants
Target number of participants: 100
Treatments
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.
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).
Related Therapeutic Areas
Sponsors
Leads: University of Wisconsin, Madison
Collaborators: National Institute of General Medical Sciences (NIGMS)

This content was sourced from clinicaltrials.gov