Clinical Signs and Symptoms of Biofilm‐Associated Infection in Chronic Wounds: A Systematic Review of Diagnostic Accuracy Studies

The presence of biofilm in chronic wounds represents a major diagnostic challenge, as clinical manifestations are often subtle and laboratory confirmation remains limited. To identify clinical signs and symptoms (CSS) evaluated in validated tools or scales related to wound infection and biofilm, and to assess their diagnostic accuracy. A systematic review of diagnostic accuracy studies was conducted in accordance with PRISMA-DTA guidelines, searching six databases from inception to May 2025. Of 2064 records identified, four studies met inclusion criteria. All were focused on infection-related CSS; none were specifically designed to diagnose biofilm. Sensitivity and specificity varied substantially across CSS and study designs, and no validated, non-invasive diagnostic scale for biofilm was identified. The available evidence base is limited and heterogeneous. A preliminary list of candidate CSS is proposed to guide future validation studies and support earlier clinical recognition of biofilm-associated infection.