Objective: The clinical evaluation of signs and symptoms (CSS) to determine a wound’s bacterial load and infection status is paramount to wound assessment. However, heavily colonized and infected wounds are often asymptomatic, leading to poor CSS diagnostic accuracy. Point-of-care bacterial fluorescence imaging rapidly provides information about the presence and location of bacteria for consideration during an assessment. This clinical trial evaluated potential improvement in diagnostic accuracy when fluorescence imaging was used adjunctively with CSS to identify wounds with moderate-to-heavy bacterial loads during an assessment.
Method: Wounds (17 VLUs/2 DFUs) were assessed using NERDS and STONEES CSS criteria to determine the presence or absence of moderate-to-heavy bacterial load, after which a detailed treatment plan was determined and recorded by the attending clinician. 4 Fluorescence images of the wound were subsequently acquired, bacterial fluorescence was determined as being present/absent and treatment plan adjusted based on fluorescence information, if necessary.
Results: Compared to CSS alone, adjunctive use of bacterial fluorescence imaging significantly improved sensitivity (72 vs. 22%) and accuracy (74 vs. 26%) for detecting wounds with moderate to heavy bacterial loads (p<0.008). In 47% of the wounds, fluorescence images led to the identification of moderate-to-heavy loads that were missed by CSS alone. An additional 26% of wounds had treatment plan modifications post imaging, which included additional cleaning, product selection, debridement, and antimicrobial stewardship practices.
Conclusion: The findings from this pilot study suggest that incorporation of bacterial fluorescence imaging could improve the standard of care for wound assessments, which could have implications on immediate treatment decisions, as seen in 73% of study patients.