Adv Wound Care · 2021
Diagnostic Accuracy of Point-of-Care Fluorescence Imaging for the Detection of Bacterial Burden in Wounds: Results from the 350-Patient Fluorescence Imaging Assessment and Guidance Trial
Le, L., Baer, M., Briggs, P., Bullock, N., Cole, W., DiMarco, D., Hamil, R., Harrell, K., Kasper, M., Li, W., Patel, K., Sabo, M., Thibodeaux, K., & Serena, T.E.
Advances in Wound Care (Mary Ann Liebert)
In brief
This prospective, single-blind, multicenter study (the FLAAG trial, NCT03540004) tested whether adding point-of-care bacterial fluorescence imaging to a standard check of clinical signs and symptoms of infection improves detection of wounds with high bacterial loads, using wound biopsy culture as the reference, in 350 patients at 14 US outpatient wound centers. Biopsies confirmed high bacterial loads in 82% of wounds; adding fluorescence imaging raised sensitivity from 15.33% with clinical signs alone to 61.0% (p < 0.001), a statistically significant improvement, while specificity stayed comparable (84.1% with imaging added). Clinicians reported that imaging changed the treatment plan in 68.9% of wounds; the single-visit design did not measure healing outcomes.
The SerenaGroup Research Foundation conducted this trial, sponsored by MolecuLight.
Plain-language summary by SerenaGroup. See the full text for complete methods and results.
Abstract
High bacterial load contributes to chronicity of wounds and is diagnosed based on assessment of clinical signs and symptoms (CSS) of infection, but these characteristics are poor predictors of bacterial burden. Point-of-care fluorescence imaging (FL) MolecuLight i:X can improve identification of wounds with high bacterial burden (>104 colony-forming unit [CFU]/g). FL detects bacteria, whether planktonic or in biofilm, but does not distinguish between the two. In this study, diagnostic accuracy of FL was compared to CSS during routine wound assessment. Postassessment, clinicians were surveyed to assess impact of FL on treatment plan. Approach: A prospective multicenter controlled study was conducted by 20 study clinicians from 14 outpatient advanced wound care centers across the United States. Wounds underwent assessment for CSS followed by FL. Biopsies were collected to confirm total bacterial load. Three hundred fifty patients completed the study (138 diabetic foot ulcers, 106 venous leg ulcers, 60 surgical sites, 22 pressure ulcers, and 24 others). Results: Around 287/350 wounds (82%) had bacterial loads >104 CFU/g, and CSS missed detection of 85% of these wounds. FL significantly increased detection of bacteria (>104 CFU/g) by fourfold, and this was consistent across wound types ( p < 0.001). Specificity of CSS+FL remained comparably high to CSS ( p = 1.0). FL information modified treatment plans (69% of wounds), influenced wound bed preparation (85%), and improved overall patient care (90%) as reported by study clinicians. Thomas E. Serena, MD Submitted for publication June 22, 2020. Accepted in revised form August 14, 2020. *Correspondence: SerenaGroup Research Foundation, 125 Cambridge Park Drive, Ste 301, Cambridge, MA 02140, USA (e-mail: serena@serenagroups.com). ª Lam Le et al., 2020; Published by Mary Ann Liebert, Inc. This Open Access article is distributed under the terms of the Creative Commons License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. ADVANCES IN WOUND CARE, VOLUME 00, NUMBER 00 2020 by Mary Ann Liebert, Inc. DOI: 10.1089/wound.2020.1272 j1 2 LE ET AL. Innovation: This novel noncontact, handheld FL device provides immediate, objective information on presence, location, and load of bacteria at point of care. Conclusion: Use of FL facilitates adherence to clinical guidelines recommending prompt detection and removal of bacterial burden to reduce wound infection and facilitate healing.
Keywords
diagnostic accuracyfluorescence imagingwound assessmentwound infection
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