Diagnostic Accuracy of Point-of-Care Fluorescence Imaging for the Detection of Bacterial Burden in Wounds: Results from the 350-Patient Fluorescence Imaging Assessment and Guidance Trial

<b>Objective:</b> High bacterial load contributes to chronicity of wounds and is diagnosed based on assessment of clinical signs and symptoms (CSS) of infection, but these characteristics are poor predictors of bacterial burden. Point-of-care fluorescence imaging (FL) MolecuLight <i>i:X</i> can improve identification of wounds with high bacterial burden (>10⁴ colony-forming unit [CFU]/g). FL detects bacteria, whether planktonic or in biofilm, but does not distinguish between the two. In this study, diagnostic accuracy of FL was compared to CSS during routine wound assessment. Postassessment, clinicians were surveyed to assess impact of FL on treatment plan. <b>Approach:</b> A prospective multicenter controlled study was conducted by 20 study clinicians from 14 outpatient advanced wound care centers across the United States. Wounds underwent assessment for CSS followed by FL. Biopsies were collected to confirm total bacterial load. Three hundred fifty patients completed the study (138 diabetic foot ulcers, 106 venous leg ulcers, 60 surgical sites, 22 pressure ulcers, and 24 others). <b>Results:</b> Around 287/350 wounds (82%) had bacterial loads >10⁴ CFU/g, and CSS missed detection of 85% of these wounds. FL significantly increased detection of bacteria (>10⁴ CFU/g) by fourfold, and this was consistent across wound types (<i>p</i> < 0.001). Specificity of CSS+FL remained comparably high to CSS (<i>p</i> = 1.0). FL information modified treatment plans (69% of wounds), influenced wound bed preparation (85%), and improved overall patient care (90%) as reported by study clinicians. <b>Innovation:</b> This novel noncontact, handheld FL device provides immediate, objective information on presence, location, and load of bacteria at point of care. <b>Conclusion:</b> Use of FL facilitates adherence to clinical guidelines recommending prompt detection and removal of bacterial burden to reduce wound infection and facilitate healing.