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.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Signal to Background Ratio (SBR) of ICGA and SWIG Fluorescence Images
Timeframe: up to 96 hours after injury (up to 4 days on study)
Standard Deviation of ICGA and SWIG Fluorescence Images
Timeframe: up to 96 hours after injury (up to 4 days on study)
Spatial Pattern of ICGA and SWIG Fluorescence Images
Timeframe: up to 96 hours after injury (up to 4 days on study)
Burn Surgeon Assessment of Wound Healing (Yes/No)
Timeframe: up to 24 days from burn injury (up to 21 days on study)
Burn Surgeon Assessment of Graft Loss (Yes/No)
Timeframe: 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
Timeframe: sample collected up to 4 days on study