Study protocol for the development of a core outcome set (COS) for clinical effectiveness trials of bordered foam dressings in the treatment of complex wounds

Fluid handling by foam wound dressings: From engineering theory to advanced laboratory performance evaluations

“…Queen et al 86 suggested 2000–2500 g/m 2 /24 h for optimal moisture without desiccation risk. Dressings with advanced wound contact layers can maintain higher WVTR, emphasizing the need for a holistic approach in dressing selection 82,87‐90 …”

Little news is good news? What is missing in the recently published EN 13726:2023 test standard for wound dressings

“…Relevant clinical experience and judgement, cost‐effectiveness analyses and performance in core treatment outcomes should further be considered. 5 , 6 , 7 , 8 , 9 …”

“…These resources range from academic bioengineering laboratory studies (both experimental and in silico) to clinical trials focusing on a pre‐defined core outcome set. 1 , 5 , 6 , 7 , 8 , 9 , 10 Stakeholders in the wound care arena should be thoughtful in not relying solely on EN 13726 2 , 3 as their source of information for decision‐making. They should strive for a delicate balance, recognizing the significance of laboratory techniques while remaining mindful of other types of peer‐reviewed evidence as well as their available resources and other constraints.…”

“…Embracing a holistic approach and a comprehensive framework that integrates various aspects of laboratory and clinical efficacy of dressing products and the overall quality of care, using core treatment outcomes which capture these variables altogether, is essential in this process. 1 , 5 , 6 , 7 , 8 , 9 , 10 Importantly, interpreting or attempting to draw conclusions from data generated using the EN 13726:2023 standard 3 must be approached with high caution and using other evidence in the literature, as this standard still needs substantial improvements to represent the clinical reality of wound care.…”

Mechanical and contact characteristics of foam materials within wound dressings: Theoretical and practical considerations in treatment

“…Ideally, a foam dressing should have a stiffness level that is similar to that of native skin, to avoid sharp stiffness gradients between the dressing and peri‐wound skin which may imprint the skin, that is, create localised, sustained soft‐tissue distortions under the dressing and particularly at the perimeter or borders of the applied dressing, which may compromise cell and tissue viability over time (Figure 2A). 5,22,23 Concurrently with this requirement, the borders of a foam dressing should have the capability to prevent any leakage of exudate to the peri‐wound skin, to prevent inflammation or maceration and subsequent skin breakdown 24,25 . McKee et al 26 reviewed the range of stiffnesses reported for human skin evaluated by means of indentation testing, which is the relevant loading mode to the interaction with dressings.…”