(LR-033) Improved Performance Evaluations of Wound Dressings in the Context of Exuding Wounds: Advancing Beyond Outdated Laboratory Test Methods

Anna Svensby, M.Sc – Wound Care Research and Development – Mölnlycke Health Care; Marina Craig, PhD – Wound Care Research and Development – Mölnlycke Health Care; Jenny Holmberg, PhD – Wound Care Research and Development – Mölnlycke Health Care; Breda Cullen, PhD – RedC Consultancy; Amit Gefen, Prof – Department of Biomedical Engineering, Faculty of Engineering, Tel Aviv University, Tel Aviv, Israel; Skin Integrity Research Group (SKINT), University Centre for Nursing and Midwifery, Department of Public Health and Primary Care, Ghent University, Ghent, Belgium; Department of Mathematics and Statistics and the Data Science Institute, Faculty of Sciences, Hasselt University, Hasselt, Belgium.

Introduction: Effective management of wound exudate is a critical function of advanced wound dressings. Reliable laboratory evaluations are essential to predict clinical performance, yet current testing standards often fail to reflect real-world conditions.¹ This study critiques the EN 13726:2023 Fluid Handling Capacity (FHC) test and introduces two key innovations: A novel biologically relevant simulated wound fluid (SWF-A)² and an advanced wound simulator (FLUHTE)³. These advancements aim to bridge the gap between laboratory assessments and clinical outcomes.

Methods: The FHC of eight bordered and non-bordered dressings was assessed using three test fluids: ‘Solution A,’ a protein-free aqueous salt solution; a serum-containing solution (SCS) representing chronic wound exudates; and SWF-A, designed to replicate physiological protein, salt, and buffer concentrations.² Comparative analyses of the physicochemical fluid properties were conducted. To achieve a higher level of evidence, additional FHC testing of nineteen dressings was performed at an independent research institute using ‘Solution A’ and SWF-A. Furthermore, the FLUHTE system was utilized to simulate clinically relevant conditions, including directional fluid flow and a vertical dressing orientation.³

Results: SWF-A and SCS yielded significantly lower FHC values for half of the wound dressings compared to ‘Solution A’, revealing limitations of simplified fluids in laboratory evaluations.² SWF-A closely mirrored SCS in key properties, demonstrating its suitability for more clinically accurate performance assessments. The FLUHTE test system proved to be highly effective in identifying clinically relevant dressing failures, i.e., cases of exudate pooling and leakage that are overlooked in the EN 13726:2023 standard.³

Discussion: Our findings highlight the inadequacy of the widely used standard test fluid ‘Solution A’ and current methodologies in evaluating wound dressing performance. By integrating SWF-A and the FLUHTE system, laboratory assessments now account for critical clinical variables that were so far disregarded, such as the composition / consistency of the exudate and the wound and dressing orientation. These innovations enable more reliable predictions of dressing performance in the clinic, supporting evidence-based selection and optimizing patient outcomes.