Bacterial Fluorescence Imaging Guides Wound Assessment, Wound Bed Preparation, and Treatment Plan in a Multisite Clinical Trial

Objective: Wound assessment is paramount for understanding the wound bioburden and the decisions a clinician must make re: wound bed preparation and treatment plan. Point-of-care fluorescence imaging visualizes bacteria at moderate/heavy loads in real-time. The potential of this imaging device to guide wound assessment and wound care decision making was assessed as part of a multi-site clinical trial (NCT03540004).

Methods: 166 chronic wounds (70 DFU/42 VLU/19 PU/26 SSI) were assessed for clinical signs and symptoms (CSS) based on IWII guidelines by 15 clinicians across 10 trial sites and treatment plan was recorded. Fluorescence images (FL) were then acquired and clinicians determined whether bacterial fluorescence was present (FL+). Treatment plan could then be modified based on fluorescence-based information. A questionnaire was used to assessed whether fluorescence images guided aspects of assessment, T.I.M.E. wound bed preparation, and treatment plan.

Results: Clinicians reported that fluorescence image information was useful in 84% of wound assessments. Fluorescence information changed the clinician’s overall assessment of wound in 104/166 patients (63%); this included 89% of CSS-/FL+ patients and 45% of CSS+/FL+ patients, demonstrating the benefit of bacterial localization even in CSS+ wounds.  Clinicians reported that fluorescence images guided sampling location (63% of wounds), cleaning (55%), debridement (51%), treatment selection (64%), and wound documentation (61%). Furthermore, T.I.M.E. wound bed prep was assisted by fluorescence information in 89% of wounds (primarily tissue management and infection control).

Conclusions: Results from 15 clinicians demonstrate widespread utility of this fluorescence imaging device, across numerous wound types and clinic sites, for guiding wound assessment, T.I.M.E. wound bed preparation, and overall treatment plan.