Underappreciated bacterial burden in pressure ulcers: clinical trial and real-world evidence

Background: Pressure injuries are typically caused by pressure, shear or moisture. Once the injury is present, bacterial infection is the confounding factor that can lead to poor healing, progressive increase in size, osteomyelitis, hospitalization, sepsis, and death. Early detection of bacterial burden is therefore critical. Point-of-care fluorescence (FL) scanning* as a direct method of bacterial detection and localization has changed wound bacterial hygiene and management practices. Clinical trials report significantly enhanced detection of bacterial burden over standard assessment alone1. To assess impact of FL-scanning on bacterial management in pressure ulcers we compared real-world evidence from a hospital outpatient wound care center to clinical trial data.Methods: The single-timepoint 350-patient (sub-analysis: 22 PUs) FLAAG clinical trial included signs/symptoms assessment with IWII guidelines2, FL-scanning, and wound biopsies. Longitudinal real-world evidence was collected in 2020-2021 from 31 consecutive PU outpatients (48% female) scanned at each visit to inform wound management (range: 3-18 visits with FL-scans/patient).Results: Clinical trial. Biopsies revealed that all PUs had bacterial loads of concern (range: 104 –108 CFU/g, median 106 CFU/g). Only 2/22 (9%) were identified as positive for bacteria based on signs/symptoms assessment, while FL-imaging correctly identified 68% (15/22) of PUs as positive for bacteria.Real-world. FL-imaging signals indicated bacterial loads of concern were present in 94% of PUs (29/31) at some point during their care. Bacterial regions visualized were iteratively addressed with hygiene strategies and re-scanned to determine any remaining bacterial presence. When bacterial signals remained, antimicrobial dressings were employed; antibiotics were prescribed only when wound associated cellulitis3 was suspected. Notably, bacterial burden was more dynamic in PUs than in other wound types; it rapidly returned, without symptoms, in a subset of patients, therefore required frequent monitoring.Real-world impact: With frequent bacterial monitoring and immediate intervention healing rates improved and no PU patients required hospitalization. This is a noteworthy departure from our institution’s and the field’s historical norms of frequent hospitalization in this high-risk outpatient population. Frequent FL-imaging is therefore recommended to enhance bacterial detection, hygiene, and care plans for all PU patients.*MolecuLight