Abstract
To investigate a dimpled, non-bordered foam dressing with a soft silicone wound contact layer, the research spans from bench (fluid handling performance) to bedside (clinical effectiveness on exuding chronic wounds). In vitro methodology was used to monitor the fluid handling capacity and fluid retention capacity of the investigational dressing compared to other commercially available foam dressings according to standard EN 13726:2023. To provide complementary clinically relevant fluid handling results, more advanced laboratory tests were conducted using the FLUHTE (FLUid Handling Test Equipment) wound simulator. In a paired clinical investigation, moderately to highly exuding chronic wounds of patients had the investigational dressing applied as part of the wound management regime, and healing-related parameters were assessed for up to six weeks. The investigational dressing significantly outperformed the other dressings in fluid dispersion ability. Overall, the investigational dressing performed well in terms of fluid handling, including under compression. In the clinical investigation, the use of the dressing was associated with substantial wound improvement, reductions in size and exudate levels, and improved patient quality of life scores. At the final visit, nine (13.2%) patients had wounds that had healed. There were no adverse device effects reported. Data from the advanced laboratory tests highlighted the substantial impact of dressing design on fluid handling performance. The investigational dressing effectively handled fluid, even when subjected to mechanical forces mimicking those that it would be subjected to in the clinical setting. The clinical results support the use of the dressing on moderately and highly exuding chronic wounds of various clinical origins.