Routine Assessment of Chronic Wounds with a New Handheld Imaging Device Can Efficiently Incorporate Wound Size and Bacteria Fluorescence Information at the Point-of-care: A 50-patient Clinical Trial

Introduction: Real-time knowledge of a wound’s size and bacterial status during routine wound assessment could facilitate more rapid treatment decision making. A handheld imaging device with wound measurement and bacterial fluorescence (FL) detection capabilities was evaluated as part of a clinical trial (#NCT03754426).

Methods: 50 wounds (36 DFUs/4 VLUs/3 arterial ulcers/7 other types) were imaged. Two wound measurement stickers were placed around the wound for calibration and a standard photo was taken, from which the device measurement software recorded wound area (cm2) as well as the maximum length and width of the wound. Stickers were removed, the room was made dark, and the device’s safe violet light was used to illuminate the wound for fluorescence imaging. Wounds exhibiting red/pink/blush or cyan fluorescence were considered bacterial fluorescence positive and swab cultures were obtained for validation.

Results: Capturing images required approximately one minute of time. 48/50 wounds (96%) were easily measured using the device software. The remaining two wounds failed to measure due to inappropriate sticker placement, preventing sticker detection. The average wound area, based on wound circumference, was 5.1 cm2 (range: 0.3 – 43.4 cm2). In contrast, computing wound area based on conventional maximum length and width calculations resulted in a 70% overestimation compared to circumference-based measurements. 36/50 wounds (72%) were positive for red/pink/blush or cyan fluorescence. Cultures confirmed that red/pink/blush and cyan on fluorescence images was associated with moderate-to-heavy bacterial loads. Predominant species included Staphylococcus aureus and Pseudomonas aeruginosa. 

Conclusions: The handheld wound imaging device immediately documented wound area, length, width, and the presence and location(s) of bacterial fluorescence across diverse wound types. Microbiological cultures confirmed bacterial status approximately 3 days later. Results suggest easy incorporation of this technology into routine wound assessments, providing real-time wound size and bacterial information for documentation that could assist clinicians during routine wound care.