Efficacy of a bacterial fluorescence imaging device in an outpatient wound care clinic: a pilot study

Hurley, Ciaran M; McClusky, Pat; Sugrue, Ryan; Clover, James; Kelly, Jason E

doi:10.12968/jowc.2019.28.7.438

Cited by 44 publications

(70 citation statements)

References 17 publications

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“…The addition of bacterial fluorescence information by way of real-time imaging, improved sensitivity and accuracy of assessments for detecting moderate-to-heavy bacterial loads. There is a growing body of evidence to support the use of point-of-care bacterial fluorescence imaging to identify chronic wounds, 31,[57][58][59]30,32,60 burns, 27,29,61,62 surgical 27 and traumatic wounds. 27,28,62 These studies, representing more than 200 imaged wounds, largely concluded that fluorescence information improved detection of clinically-concerning levels of bacteria, thus empowering evidence-based treatment decisions including treatment selection 28,30,57,[62][63][64] and antimicrobial stewardship practices.…”

Section: Discussionmentioning

confidence: 99%

“…Moreover, the percentage of enrolled patients that were true negatives based on microbiology (bacterial load <10 4 CFU/g, 1/19 patients) was surprisingly low, preventing statistical testing of specificity and challenging the ability to determine NPV in this patient cohort (though these have been reported in other studies; recent reports of NPV have ranged from 90 to 100%). 27,60,61 This may have been due, at least in part, to the study's exclusion of patients on antibiotics. Patients actively taking systemic or oral antibiotics would be anticipated to have low bacterial loads.…”

Section: Limitationsmentioning

confidence: 99%

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Real-time bacterial fluorescence imaging accurately identifies wounds with moderate-to-heavy bacterial burden

et al. 2019

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Objective: Clinical evaluation of signs and symptoms (CSS) of infection is imperative to the diagnostic process. However, patients with heavily colonised and infected wounds are often asymptomatic, leading to poor diagnostic accuracy. Point-of-care fluorescence imaging rapidly provides information on the presence and location of bacteria. This clinical trial (#NCT03540004) aimed to evaluate diagnostic accuracy when bacterial fluorescence imaging was used in combination with CSS for identifying wounds with moderate-to-heavy bacterial loads. Methods: Wounds were assessed by study clinicians using NERDS and STONEES CSS criteria to determine the presence or absence of moderate-to-heavy bacterial loads, after which the clinician prescribed and reported a detailed treatment plan. Only then were fluorescence images of the wound acquired, bacterial fluorescence determined to be present or absent and treatment plan adjusted if necessary. Results: We examined 17 VLUs/2 DFUs. Compared with CSS alone, use of bacterial fluorescence imaging in combination with CSS significantly improved sensitivity (22% versus 72%) and accuracy (26% versus 74%) for identifying wounds with moderate-to-heavy bacterial loads (≥104 CFU/g, p=0.002). Clinicians reported added value of fluorescence images in >90% of study wounds, including identification of wounds incorrectly diagnosed by CSS (47% of study wounds) and treatment plan modifications guided by fluorescence (73% of study wounds). Modifications included image-guided cleaning, treatment selection, debridement and antimicrobial stewardship. Conclusion: Findings from this pilot study suggest that when used in combination with CSS, bacterial fluorescence may: (1) improve the diagnostic accuracy of identifying patients with wounds containing moderate-to-heavy bacterial loads and (2) guide more timely and appropriate treatment decisions at the point-of-care.

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Section: Discussionmentioning

confidence: 99%

Section: Limitationsmentioning

confidence: 99%

Real-time bacterial fluorescence imaging accurately identifies wounds with moderate-to-heavy bacterial burden

et al. 2019

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“…Fluorescence imaging detects 87% of the most common wound pathogens, 14 including Pseudomonas aeruginosa, which uniquely produces a cyan fluorescent signature due to endogenous pyoverdine production; a small number of bacterial genera (Streptococcus and Enterococcus) do not emit detectable fluorescence signals. 15 Multiple clinical studies report positive predictive values over 87% when using fluorescence imaging to detect bacteria at loads greater than 10 4 CFU/g 13,16,17 on and beneath the surface of wounds, up to 1.5mm depth. 18 The device also contains digital wound area measurement software that automatically detects the wound border Use of a bacterial fluorescence imaging system to target wound debridement and accelerate healing: a pilot study If bacterial fluorescence remained after aggressive, targeted debridement, clinician employed antimicrobials and/or antibiotics and generates instant, accurate wound measurements (wound surface area, length and width).…”

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confidence: 99%

Use of a bacterial fluorescence imaging system to target wound debridement and accelerate healing: a pilot study

Cole

Coe

2020

J Wound Care

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Objective: Optimal wound-bed preparation consists of regular debridement to remove devitalised tissues, reduce bacterial load, and to establish an environment that promotes healing. However, lack of diagnostic information at point-of-care limits effectiveness of debridement. Method: This observational case series investigated use of point-of-care fluorescence imaging to detect bacteria (loads >104CFU/g) and guide wound bed preparation. Lower extremity hard-to-heal wounds were imaged over a 12-week period for bacterial fluorescence and wound area. Results: A total of 11 wounds were included in the study. Bacterial fluorescence was present in 10 wounds and persisted, on average, for 3.7 weeks over the course of the study. The presence of red or cyan fluorescent signatures from bacteria correlated with an average increase in wound area of 6.5% per week, indicating stalled or delayed wound healing. Fluorescence imaging information assisted in determining the location and extent of wound debridement, and the selection of dressings and/or antimicrobials. Elimination of bacterial fluorescence signature with targeted debridement and other treatments correlated with an average reduction in wound area of 27.7% per week (p<0.05), indicative of a healing trajectory. Conclusion: These results demonstrate that use of fluorescence imaging as part of routine wound care enhances assessment and treatment selection, thus facilitating improved wound healing.

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“…The MolecuLight i:X imaging device is a novel, handheld, point-of-care diagnostic imaging tool designed to accurately and digitally measure wound areas and to provide objective, real-time evidence on the presence and location of high bacterial loads (both planktonic and in biofilm. [11][12][13][14][15][16] This provides objective documentation, performed at the bedside, during which the device captures an image in a format compatible with most electronic medical records (EMR) systems. The device contains built-in digital wound measurement software and emits a safe violet light which is used for non-invasive, contrast agent free fluorescence imaging to identify regions with concerning levels of bacteria in real-time.…”

mentioning

confidence: 99%

Use of a bacterial fluorescence imaging device: wound measurement, bacterial detection and targeted debridement

Raizman

Dunham²,

Lindvere-Teene³

et al. 2019

J Wound Care

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Objective: Diagnostics which provide objective information to facilitate evidence-based treatment decisions could improve the chance of wound healing. Accurate wound measurements, objective bacterial assessment, and the regular, consistent tracking of these parameters are important aspects of wound care. This study aimed to assess the accuracy, clinical incorporation and documentation capabilities of a handheld bacterial fluorescence imaging device (MolecuLight i:X). Method: Benchtop wound models with known dimensions and clinical wound images were repeatedly measured by trained clinicians to quantify accuracy and intra/inter-user coefficients of variation (COV) of the imaging device measurement software. In a clinical trial of 50 wounds, wound dimensions were digitally measured and fluorescence images were acquired to assess for the presence of bacteria at moderate-to-heavy loads. Finally, fluorescence imaging was implemented into the routine assessment of 22 routine diabetic foot ulcers (DFU) to determine appropriate debridement level and location based on bacterial fluorescence signals. Results: Wound measurement accuracy was >95% (COV <3%). In the clinical trial of 50 wounds, 72% of study wounds demonstrated positive bacterial fluorescence signals. Levine sampling of wounds was found to under-report bacterial loads relative to fluorescence-guided curettage samples. Furthermore, fluorescence documentation of bacterial presence and location(s) resulted in more aggressive, fluorescence-targeted debridement in 17/20 DFUs after standard of care debridement failed to eliminate bacterial fluorescence in 100% of DFU debridements. Conclusion: The bacterial fluorescence imaging device can be readily implemented for objective, evidenced-based wound assessment and documentation at the bedside. Bedside localisation of regions with moderate-to-heavy bacterial loads facilitated improved sampling, debridement targeting and improved wound bed preparation.

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Efficacy of a bacterial fluorescence imaging device in an outpatient wound care clinic: a pilot study

Cited by 44 publications

References 17 publications

Real-time bacterial fluorescence imaging accurately identifies wounds with moderate-to-heavy bacterial burden

Real-time bacterial fluorescence imaging accurately identifies wounds with moderate-to-heavy bacterial burden

Use of a bacterial fluorescence imaging system to target wound debridement and accelerate healing: a pilot study

Use of a bacterial fluorescence imaging device: wound measurement, bacterial detection and targeted debridement

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