Wounds International 2021;12(2):20-26
Gefen, A., Santamaria, N.
Introduction
- It is well established that a moist wound bed is conducive to healing.
- Evaluating the ability of dressings to induce such conditions in the wound bed, while also preventing leakage and minimising peri-wound skin maceration, is challenging.
- Clinical measurements of the fluid handling properties of wound dressings are not feasible due to the considerable variability among patients, wounds, methods of practice and care protocols.
- Laboratory tests are commonly used to eliminate these variabilities, thus allowing the fluid handling performances of dressings in controlled setups and under pre-set test conditions.
- Clinicians, product engineers, health care administrators, regulatory agencies and reimbursement bodies are all dependent on reliable, reproducible, robust and cost-effective testing methods and their outcomes for adequate decision-making processes.
Aims
- To review the existing laboratory testing standards that are commonly employed by industry and university laboratories to evaluate wound dressing performance.
- To discuss the relevance of the laboratory testing standards to real-world, clinical use of wound dressings.
Methods
- Multidisciplinary narrative review.
- Focus on foam dressings.
Key findings/recommendations
- There are recognised gaps between the real-world, clinically relevant conditions pertaining to the use of wound dressings and the simplifications (or sometimes, oversimplifications) made in existing testing standards relating to the evaluation of dressing performance in laboratories
- There is an urgent requirement to replace the traditional laboratory testing standards for wound dressings with improved standards that recognise the following:
- Real-world scenarios of fluid flow into dressings, i.e. only through the wound contact surface
- Biophysical properties of wound exudate managed in clinical practice and, in particular, the viscosity of exudate which may deviate substantially from that of water or saline.
- Compressive and shear mechanical forces that may act on dressings and cause them to release absorbed fluids
- Instructions for use provided by manufacturers should conform to clinical practice, avoiding the term ‘saturation’ which has a specific physical and engineering meaning and implications as a descriptor for when a dressing needs to be changed. A saturation state of a dressing is clearly unwarranted in clinical practice.
Conclusions
- It appears that existing testing standards are not suitable for evaluating the performance of many wound dressings in the laboratory.
- New, dedicated, scientifically sound and clinically valid testing methods need to be developed for wound dressings.
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Saturation of a dressing applied to an exuding wound: the gap between clinical judgment and laboratory testing
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