How Should Clinical Wound Care and Management Translate to Effective Engineering Standard Testing Requirements from Foam Dressings? Mapping the Existing Gaps and Needs

Abstract

Significance: Wounds of all types remain one of the most important, expensive and common medical problems, e.g., up to approximately two-thirds of the work time of community nurses is spent on wound management. Many wounds are treated by means of dressings. The materials used in a dressing, their microarchitecture and how they are composed and constructed form the basis for the laboratory and clinical performances of any advanced dressing. Recent Advances:The established structure-function principle in material science is reviewed and analyzed in this article in the context of wound dressings. This principle states that the microstructure determines the physical, mechanical, and fluid transport and handling properties, all of which are critically important for, and relevant to the adequate performances of wound dressings.Critical Issues: According to the above principle, once the clinical requirements for wound care and management are defined for a given wound type and etiology, it should be theoretically possible to translate clinically-relevant characteristics of dressings into physical test designs resulting specific metrics of materials, mechanical, and fluid transport and handling properties, all of which should be determined to meet the clinical objectives and be measurable through standardized bench testing.Future Directions: This multidisciplinary review article, written by an International Wound Dressing Technology Expert Panel, discusses the translation of clinical wound care and management into effective, basic engineering standard testing requirements from wound dressings with respect to material types, microarchitecture and properties, to achieve the desirable performance in supporting healing and improving the quality of life of patients.* e.g., in the TIME model -a widely used practical guide to wound management developed by a global team of wound care experts, which relates clinical observations and interventions to the underlying wound pathology in several aspects, including moisture imbalance. 15

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

“…and is responsible for the design and coordination of the project and will make final decisions. The International Wound Dressing Technology Expert Panel (IWDTEP) 22 will provide guidance throughout the development of the COS. Stakeholder involvement will be ensured throughout the process to: (1) increase the number of ideas, perspectives, and issues considered; (2) ensure credibility, relevance, and significance to diverse groups; (3) increase face validity; (4) identify concerns and barriers that otherwise would not have been considered; (5) ensure transparency; and (6) increase acceptance and dissemination of the project. 23 Stakeholders will be represented in four ways.…”

“…Several benefits can be derived from these specific features, such as reduced tissue maceration and a decreased likelihood on dressing-related trauma. 4,[7][8][9][10][11] A broad range of bordered foam dressings exist on the market. In general, they consist of at least a primary hydrophilic open-cell foam layer with high a high absorption capacity, a waterproof adhesive backing, and a margin often made of silicone that covers the peri-wound area and allows the dressing to stay in place.…”

An Absorbent, Flexible, Transparent, and Scalable Substrate for Wound Dressings

“…Gauze dressings require frequent replacement and adhere to the wound bed, thus removal causes severe detriment to the delicate wound bed and inhibits wound healing [8] , [9] . Low adherent dressings allow exudate to pass through into a secondary dressing while maintaining a moist wound bed [10] . They are useful for patients with sensitive or fragile skin because they are designed to reduce adherence at the wound bed.…”

The vision and scope of the prophylactic dressing standard initiative of the European Pressure Ulcer Advisory Panel and National Pressure Injury Advisory Panel

“…However, EN 13726 has been criticised in the literature for lack of clinical relevance. 9 Moreover, the application of dressings for prophylaxis is not currently addressed in any existing test standard, including in the EN 13726. Accordingly, and despite there being some overlap between characteristics important to pressure ulcer/injury prevention and factors important to wound healing, the PDSI chose to limit its scope to prophylactic use of dressings only, and as related to pressure ulcers/injuries (but not other wound aetiologies), to focus energy on the current urgent need for validated methods to compare dressing products for these preventative purposes.…”

“…Standards exist for wound dressings concerning their characteristics related to treatment of existing wounds (EN 13726 8 ). However, EN 13726 has been criticised in the literature for lack of clinical relevance 9 . Moreover, the application of dressings for prophylaxis is not currently addressed in any existing test standard, including in the EN 13726.…”