1. Clinical significance of a novel imaging device to evaluate infection on wounds: Performance comparison with culture method and metagenome sequencing.
- Author
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Kesavan, Rajesh and Sasikumar, Changam Sheela
- Subjects
DIAGNOSTIC imaging equipment ,DIGITAL image processing ,STATISTICS ,SEQUENCE analysis ,PREDICTIVE tests ,CLINICAL trials ,CONFIDENCE intervals ,DIABETIC foot ,WOUND infections ,MACHINE learning ,RNA ,COMPARATIVE studies ,GENOMICS ,COMMERCIAL product evaluation ,DESCRIPTIVE statistics ,DATA analysis software ,SENSITIVITY & specificity (Statistics) ,MICROBIAL sensitivity tests ,PROBABILITY theory - Abstract
Background Diabetic foot and lower limb complications affect 40-60 million people globally. A rapid method is needed to understand the bioburden and type of infecting bacteria on diabetic foot ulcers. Aim To compare the accuracy and efficacy of a novel multispectral imaging device, against the standard culture method and correlate bacterial bioburden levels with metagenome sequencing. Method A clinical study was conducted on diabetic foot ulcer patients. Wounds, post-debridement, were imaged using the multispectral imaging device and the report, containing spatially mapped regions of bacterial burden along with their bacterial gram type, was compared with the culture sensitivity report. Additionally, metagenome sequencing was done on a subset of the patient samples.Results A total of 157 patients were imaged, and 177 deep tissue biopsies were taken from colour-coded regions (Gram Positive/Gram Negative infected) identified by the machine learning algorithm. The class-averaged accuracy of the device was found to be 90.4% for gram-positive, -negative, polymicrobial and for no bacterial burden. A total of 26 biopsies were also sent for 16S rRNA sequencing. Of these, cultures were positive in 17 and correlated with the species identified through 16S rRNA results in 16 cases. In five cases where there was no growth in culture, the multispectral imaging device could still detect the presence of bacteria as confirmed by 16S rRNA results (using 50 reads as a cut-off) and thus be used as an adjunct for monitoring wounds' bacterial burden over time. Conclusions The novel multispectral imaging device can be used to effectively understand the bioburden in a wound of clinical significance and the gram type of infecting bacteria. Implications for clinical practice The autofluorescence imaging device can assist doctors in evaluating wounds' bacterial burden level, spatial bioburden extent and the gram type of bacteria present, thus aiding in effective debridement and proper wound-management protocols. [ABSTRACT FROM AUTHOR]
- Published
- 2022