Real-world Evidence Demonstrating Utility of Bacterial Fluorescence Imaging to Guide Treatment Decision Making in 135 Wounds

Abstract Body: Introduction: Evaluation of clinical signs and symptoms of infection is the current standard of care (SoC) for assessing bacterial colonization in wounds and is used to inform wound care treatment plans. However, the sensitivity of SoC bacterial-infection assessment is poor1. Multi-site clinical trials ( >400 patients) report red and cyan colors on fluorescence images* as having a positive predictive value of >95% for detecting bacterial loads >104 CFU/g1-4. Here we report 1) real-world evidence comparing fluorescence imaging to SoC to determine the prevalence of bacteria-positive wounds, and 2) how fluorescence images helped guide treatment plans. Methods: 135 chronic wounds were assessed, with no exclusion criteria. Clinicians (60% MD, 35% DPM, 4% PT) assessed the wounds and described the treatment plan.  Fluorescence images were acquired and changes to the treatment plan were recorded. Results: Fluorescence imaging detected bacterial fluorescence in 3.6-fold more wounds compared to SoC. SoC suggested significant bacterial loads in 22% of wounds while fluorescence imaging detected bacteria (red or cyan fluorescence) in 81% of wounds (55% red, 7% cyan, 19% red and cyan fluorescence). Fluorescence information prompted a treatment change in 68% of wounds. Changes included: more extensive debridement (50%), fluorescence-guided cleaning (27%), changes in dressing selection (21%), and/or addition of antimicrobials (20%). Conclusion: Fluorescence imaging by 27 clinicians across 9 states more frequently detected bacteria in wounds than SoC. Real-time detection of bacteria using fluorescence imaging can be easily incorporated into routine wound assessments and guide treatment decision making across multiple wound types.