The importance of the simulated wound fluid composition and properties in the determination of the fluid handling performance of wound dressings.

Effective fluid handling by wound dressings is crucial in the management of exuding wounds through maintaining a clean, moist environment, facilitating healing by removing excess exudate and promoting tissue regeneration. In this context, the availability of reliable and clinically relevant standardised testing methods for wound dressings are critical for informed decision making by clinicians, healthcare administrators, regulatory/reimbursement bodies and product developers. The widely used standard EN 13726 specifies the use of Solution A, an aqueous protein-free salt solution, for determining fluid-handling capacity (FHC). However, a simulated wound fluid (SWF) with a more complex composition, resembling the protein, salt, and buffer concentrations found in real-world clinical exudate, would provide a more clinically relevant dressing performance assessment. This study compared selected physicochemical parameters of Solution A, an alternative, novel simulated wound fluid (SWF A), and a benchmark reference serum-containing solution (SCS) simulating chronic wound exudate. Additionally, FHC values for eight advanced bordered and non-bordered foam dressings were determined for all three test fluids, following EN 13726. Our findings demonstrate a close resemblance between SWF A and SCS. This study highlights the critical importance of selecting a physiochemically appropriate test fluid for accurate FHC testing resulting in clinically meaningful evaluation of dressing performance.

The frictional energy absorber effectiveness and its impact on the pressure ulcer prevention performance of multilayer dressings.

Pressure ulcers including heel ulcers remain a global healthcare concern. This study comprehensively evaluates the biomechanical effectiveness of the market-popular ALLEVYN® LIFE multilayer dressing in preventing heel ulcers. It focuses on the contribution of the frictional sliding occurring between the non-bonded, fully independent layers of this dressing type when the dressing is protecting the body from friction and shear. The layer-on-layer sliding phenomenon, which this dressing design enables, named here the frictional energy absorber effectiveness (FEAE), absorbs approximately 30%-45% of the mechanical energy resulting from the foot weight, friction and shear acting to distort soft tissues in a supine position, thereby reducing the risk of heel ulcers. Introducing the novel theoretical FEAE formulation, new laboratory methods to quantify the FEAE and a review of relevant clinical studies, this research underlines the importance of the FEAE in protecting the heels of at-risk patients. The work builds on a decade of research published by our group in analysing and evaluating dressing designs for pressure ulcer prevention and will be useful for clinicians, manufacturers, regulators and reimbursing bodies in assessing the effectiveness of dressings indicated or considered for prophylactic use.

Enhancing prone positioning and skin damage prevention education: A randomized controlled non-inferiority trial comparing a digital education hub (PRONEtect) and a traditional lecture on final-year nursing participants' confidence and knowledge.

INTRODUCTION: The incidence of pressure ulcers remains high in patients with moderate to severe acute respiratory distress syndrome, ventilated in the prone position. A digital platform, dedicated to prone positioning and skin/tissue damage education was developed. OBJECTIVE: To evaluate the impact of the PRONEtect Education Hub versus a traditional lecture on final-year nursing students' confidence levels and knowledge in a non-inferiority study. DESIGN: A multicenter, non-blinded, parallel-group, non-inferiority study with equal randomization (1:1 allocation) was conducted at two nursing schools in Belgium. CLINICALTRIALS: gov (NCT05575869). METHODS: Following baseline assessments, the control group received a 1-h classroom lecture, and the experimental group gained access to the PRONEtect website. Three weeks later, participants completed the knowledge, confidence, and visual knowledge assessment. RESULTS: At baseline, 67 of the 80 participants completed the assessments and post-intervention, 28 and 27 participants respectively completed the confidence, knowledge, and visual knowledge assessments (dropout rate of 66.25%). Confidence levels: a mean ratio of relative change from baseline = 0.96 (Control (C)/Experimental (E)); 97.5% confidence interval (CI): 0.74 to 1.26; p = 0.74. Knowledge assessment: a mean difference in change from baseline = 1.58 (C-E); 97.5% CI: -0.58 to 3.75; p = 0.1. Although confidence and knowledge scores increased in both groups, the study cannot conclude non-inferiority. CONCLUSIONS: The trade-off between the inability to conclude efficacy of the impact of the website and the benefit of having an accessible educational platform on prone positioning and skin damage prevention makes the PRONEtect Education Hub an acceptable adjunct to traditional lecturing.

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

This article describes the contemporary bioengineering theory and practice of evaluating the fluid handling performance of foam-based dressings, with focus on the important and clinically relevant engineering structure-function relationships and on advanced laboratory testing methods for pre-clinical quantitative assessments of this common type of wound dressings. The effects of key wound dressing material-related and treatment-related physical factors on the absorbency and overall fluid handling of foam-based dressings are thoroughly and quantitively analysed. Discussions include exudate viscosity and temperature, action of mechanical forces and the dressing microstructure and associated interactions. Based on this comprehensive review, we propose a newly developed testing method, experimental metrics and clinical benchmarks that are clinically relevant and can set the standard for robust fluid handling performance evaluations. The purpose of this evaluative framework is to translate the physical characteristics and performance determinants of a foam dressing into achievable best clinical outcomes. These guiding principles are key to distinguishing desirable properties of a dressing that contribute to optimal performance in clinical settings.

Testing the effectiveness of a polymeric membrane dressing in modulating the inflammation of intact, non-injured, mechanically irritated skin.

We investigated the inflammatory (IL-1 alpha) and thermal (infrared thermography) reactions of healthy sacral skin to sustained, irritating mechanical loading. We further acquired digital photographs of the irritated skin (at the visible light domain) to assess whether infrared imaging is advantageous. For clinical context, the skin status was monitored under a polymeric membrane dressing known to modulate the inflammatory skin response. The IL-1 alpha and infrared thermography measurements were consistent in representing the skin status after 40 min of continuous irritation. Infrared thermography overpowered conventional digital photography as a contactless optical method for image processing inputs, by revealing skin irritation trends that were undetectable through digital photography in the visual light, not even with the aid of advanced image processing. The polymeric membrane dressings were shown to offer prophylactic benefits over simple polyurethane foam in the aspects of inflammation reduction and microclimate management. We also concluded that infrared thermography is a feasible method for monitoring the skin health status and the risk for pressure ulcers, as it avoids the complexity of biological marker studies and empowers visual skin assessments or digital photography of skin, both of which were shown to be insufficient for detecting the inflammatory skin status.

A robotic venous leg ulcer system reveals the benefits of negative pressure wound therapy in effective fluid handling.

We applied a market-leading, single-use negative pressure wound therapy device to a robotic venous leg ulcer system and compared its fluid handling performance with that of standard of care, superabsorbent and foam dressings and compression therapy. For each tested product, we determined a metrics of retained, residual, evaporated and (potential) leaked fluid shares, for three exudate flow regimes representing different possible clinically relevant scenarios. The single-use negative pressure wound therapy system under investigation emerged as the leading treatment option in the aspects of adequate fluid handling and consistent delivery of therapeutic-level wound-bed pressures. The superabsorbent dressing performed reasonably in fluid handling (resulting in some pooling but no leakage), however, it quickly caused excessive wound-bed pressures due to swelling, after less than a day of simulated use. The foam dressing exhibited the poorest fluid handling performance, that is, pooling in the wound-bed as well as occasional leakage, indicating potential inflammation and peri-wound skin maceration risks under real-world clinical use conditions. These laboratory findings highlight the importance of advanced robotic technology as contemporary means to simulate patient and wound behaviours and inform selection of wound care technologies and products, in ways that are impossible to achieve if relying solely on clinical trials and experience.

Development of prone positioning and skin damage prevention digital education: the PRONEtect project.

OBJECTIVE: The incidence of skin/tissue damage, such as pressure ulcers, remains high in mechanically ventilated patients in the prone position. According to guidelines, critically ill patients with acute respiratory distress syndrome (ARDS) should be prone for at least 12-16 hours to improve oxygenation and decrease mortality. Therefore, educating clinicians on how to reposition and manage the patient safely in a prone position plays a vital role in preventing adverse events. This project aimed to develop accessible online educational content to assist clinicians in safely executing the prone manoeuvre and minimise skin/tissue damage. METHOD: The development of the educational content was based on: a gap analysis and comprehensive review of available educational resources; evidence-based scientific literature; advice from international experts; and a qualitative study exploring the learning needs of 20 clinicians in Belgium and Sweden between February-August 2022. RESULTS: Volunteer clinicians assisted with the creation of eight simulation videos which were professionally filmed and edited. The interactive videos included the supine-to-prone and prone-to-supine manoeuvres, endotracheal and nasogastric tube securement, eye care, stoma care, protecting high-risk areas from pressure damage, and incontinence-associated dermatitis prevention. A prone positioning protocol, a checklist summarising the key aspects of the protocol, and teaching aids (slide deck for didactic lecturing) were developed and validated by a review of the relevant evidence-based literature and the international expert panel. A website was designed to host the content, with free user access, at www.pronetection.com. CONCLUSION: Education is one strategy towards prevention of complications of prone positioning. Accessible education could assist clinicians unfamiliar with prone positioning or current clinicians requiring refresher training to safely manage patients in this position.

Medical Device Testing: Methods, Significance, and Clinical Applications.

GENERAL PURPOSE: To present a study conducting objective biomechanical testing of medical devices known to cause medical device-related pressure injuries (MDRPIs) in critically ill adults and comparing those results with clinical outcomes associated with each device. TARGET AUDIENCE: This continuing education activity is intended for physicians, physician assistants, nurse practitioners, and nurses with an interest in skin and wound care. LEARNING OBJECTIVES/OUTCOMES: After participating in this educational activity, the participant will:1. Explain the results of the study of the relationships between objective biomechanical tests of medical devices and clinical outcomes that help inform clinicians using these devices.2. Synthesize the background information that informed the study.

To conduct bioengineering testing of devices that cause medical device-related pressure injuries (MDRPIs) in critically ill adults and compare testing results to the MDRPI clinical outcomes associated with each device. Following the identification of MDRPI from oxygen-delivery devices and nasogastric tubes in critically ill adults who were hospitalized between January 2016 and October 2022, the specific manufacturer and model number of the devices were identified. Twelve devices and two prophylactic dressings in original packaging were sent to a bioengineering laboratory for testing. Using an integrated experimental-computational approach, the compressive elastic moduli ( E [MPa]) was measured for each device and prophylactic dressing and compared with the properties of normal adult skin. The authors hypothesized that devices with greater mechanical stiffness (ie, higher E [MPa]) would be associated with a greater number and severity of MDRPIs. Researchers identified 68 patients with 88 MDRPIs. All PI stages except stage 4 were represented. Nasogastric tubes had the highest mechanical stiffness and were the most common MDRPI identified. In contrast, no soft nasal cannula MDRPIs were reported. Devices associated with the highest number of MDRPIs also had the highest E [MPa] values; researchers noted a moderate association between E [MPa] values and pressure injury severity. Prophylactic dressings had E [MPa] values within the range of normal adult skin. The relative mechanical stiffness of a device is an important factor in MDRPI etiology. However, factors such as duration of device use, tightness when securing devices, correct fit, and heat and humidity under devices should be considered in predicting MDRPI severity.

An anatomically-realistic computational framework for evaluating the efficacy of protective plates in mitigating non-penetrating ballistic impacts.

BACKGROUND: A major threat in combat scenarios is the 'behind armor blunt trauma' (BABT) of a non-penetrating ballistic impact with a ballistic protective plate (BPP). This impact results in pressure waves that propagate through tissues, potentially causing life-threatening damage. To date, there is no standardized procedure for rapid virtual testing of the effectiveness of BPP designs. The objective of this study was to develop a novel, anatomically-accurate, finite element modeling framework, as a decision-making tool to evaluate and rate the biomechanical efficacy of BPPs in protecting the torso from battlefield-acquired non-penetrating impacts. METHODS: To simulate a blunt impact with a BPP, two types of BPPs representing generic designs of threat-level III and IV plates, and a generic 5.56 mm bullet were modeled, based on their real dimensions, physical and mechanical characteristics (plate level-III is smaller, thinner, and lighter than plate level-IV). The model was validated by phantom testing. RESULTS: Plate level-IV induced greater strains and stresses in the superficial tissues post the ballistic impact, due to the fact that it is larger, thicker and heavier than plate level-III; the shock wave which is transferred to the superficial tissues behind the BPP is greater in the case of a non-penetrating impact. For example - the area under volumetric tissue exposure histograms of strains and stresses for the skin and adipose tissues were 16.6-19.2% and 17.3-20.3% greater in the case of plate level-IV, for strains and stresses, respectively. The validation demonstrates a strong agreement between the physical phantom experiment and the simulation, with only a 6.37% difference between them. CONCLUSIONS: Our modelling provides a versatile, powerful testing framework for both industry and clients of BPPs at the prototype design phase, or for quantitative standardized evaluations of candidate products in purchasing decisions and bids.

The clinical and cost effectiveness of remote expert wound nurse consultation for healing of pressure injuries among residential aged care patients: A protocol for a prospective pilot parallel cluster randomised controlled trial.

Pressure injuries affect 1 to 46% of residents in aged care (long term) facilities and cause a substantial economic burden on health care systems. Remote expert wound nurse consultation has the potential to improve pressure injury outcomes; however, the clinical and cost effectiveness of this intervention for healing of pressure injuries in residential aged care require further investigation. We describe the remote expert wound nurse consultation intervention and the method of a prospective, pilot, cluster randomised controlled trial. The primary outcome is number of wounds healed. Secondary outcomes are wound healing rate, time to healing, wound infection, satisfaction, quality of life, cost of treatment and care, hospitalisations, and deaths. Intervention group participants receive the intervention over a 12-week period and all participants are monitored for 24 weeks. A wound imaging and measurement system is used to analyse pressure injury images. A feasibility and fidelity evaluation will be concurrently conducted. The results of the trial will inform the merit of and justification for a future definitive trial to evaluate the clinical and cost effectiveness of remote expert wound nurse consultation for the healing of pressure injuries in residential aged care.

Clinical and cost effectiveness of a system for turning and positioning intensive care unit patients, when compared to usual care turning and positioning devices, for the prevention of hospital-acquired pressure injuries. A randomised controlled trial.

Pressure injuries affect 13.1% to 45.5% of patients in the intensive care unit and lead to pain and discomfort for patients, burden on healthcare providers, and unnecessary cost to the health system. Turning and positioning systems offer improvements on usual care devices, however the evidence of the effectiveness of such systems is still emerging. We conducted an investigator initiated, prospective, single centre, two group, non-blinded, randomised controlled trial to determine the effectiveness of a system for turning and positioning intensive care unit patients, when compared to usual care turning and positioning devices, for preventing PIs. The trial was prematurely discontinued after enrolment of 78 participants due to COVID-19 pandemic related challenges and lower than expected enrolment rate. The study groups were comparable on baseline characteristics and adherence to the interventions was high. Four participants developed a PI (in the sacral, ischial tuberosity or buttock region), n = 2 each in the intervention and control group. Each participant developed one PI. As the trial is underpowered, these findings do not provide an indication of the clinical effectiveness of the interventions. There was no participant drop-out or withdrawal and there were no adverse events, device deficiencies, or adverse device effects identified or reported. The results of our study (in particular those pertaining to enrolment, intervention adherence and safety) provide considerations for future trials that seek to investigate how to prevent PIs among ICU patients.

The development of a core outcome set for clinical effectiveness studies of bordered foam dressings in the treatment of complex wounds.

AIM: The aim of this project was to develop a core outcome set (COS) for clinical effectiveness studies of bordered foam dressings in the treatment of complex wounds. METHODS: The research project followed the Core Outcome Measures in Effectiveness Trials (COMET) initiative and consisted of two phases. The first phase prepared the background and process, while the second phase had three steps: outcome list generation via systematic review and qualitative study, Delphi consensus study, and consensus meeting. The study has been registered in the Core Outcome Measures in Effectiveness Trials database. RESULTS: The systematic review resulted in 82 outcomes and 20 additional outcomes were obtained during the interviews. After refinement, 111 panellists from 23 countries rated a list of 51 outcomes. In the following consensus meeting, six outcomes were prioritized to be included in the core outcome set. After the consensus meeting, a patient-reported outcome was added to the core outcome set. CONCLUSION: The COS for evaluating the effectiveness of bordered foam dressings in treating complex wounds includes 7 outcomes: "ability to stay in place", "leakage", "pain", "dressing related periwound skin changes", "change in wound size over time", and "overall satisfaction". These identified outcomes are correlated with contemporary bioengineering testing and evaluation methods for dressing performance, which underpins the need for a close multidisciplinary collaboration to advance the field of wound dressings. The outcome 'overall satisfaction' reflects the impact of complex wounds and their treatment on a patient's daily life. The use of these outcomes is recommended to improve data synthesis and promote evidence-based practice. Future developments in COS development involve creating measurement instruments and relevant endpoints for these outcomes.

Clinical performance characteristics for bordered foam dressings in the treatment of complex wounds: An international wound dressing technology expert panel review.

The aim of this article is to identify and describe clinical practice performance characteristics for bordered foam dressings in the treatment of complex wounds. Our recently published systematic review of outcomes and applied measurement instruments for the use of bordered foam dressings in complex wounds has led to us identifying a range of important clinical and patient-centred issues related to this dressing class. Specifically, here, we focus on an overview of performance criteria in the areas of application, adhesion, exudate management and debridement functions of bordered foam dressings. Our hope is that by highlighting the clinical performance criteria, future testing standards for wound dressings will more closely match our clinical expectations and, thereby, assist clinicians to make better wound treatment choices based on meaningful and clinically relevant dressing product performance standards. complex wounds, complex wound care, treatment, bordered foam dressings, dressing performance.

The biomechanical efficacy of a hybrid support surface in protecting supine patients from sacral pressure ulcers.

Support surfaces are the most important pressure ulcer/injury prevention technology available to clinicians for protecting their at-risk patients. A hybrid support surface marries the benefits of reactive and active support surfaces, by using high-quality foam material inside inflatable air cells. When used in its "static mode", it is a constant low air pressure mattress which delivers pressure redistribution in response to patient bodyweight and movements, by maximising the immersion and envelopment performance of the support surface. When used in its powered "dynamic mode", this system further delivers alternating pressure care via the connected foam and air cells. Modes of action of hybrid support surfaces were never studied quantitatively before, excluding through the limited scope of interface pressure mapping. In this work, we developed a novel computational modelling framework and simulations to visualise and quantify the state of soft tissue loading at the buttocks of a supine patient positioned on a hybrid support surface, in both the static and dynamic modes. We found that the dynamic mode effectively shifts deep concentrated soft tissue loading from under the sacral bone (towards the sacral promontory) to the tip of the sacrum (coccyx) and vice versa, and thereby, generates a deep tissue offloading effect.

Graded stiffness offloading insoles better redistribute heel plantar pressure to protect the diabetic neuropathic foot.

BACKGROUND: Diabetic heel ulceration is a common, detrimental, and costly complication of diabetes. This study investigates a novel "graded-stiffness" offloading method, which consists of a heel support with increasing levels of stiffness materials to better redistribute plantar pressure for heel ulcer prevention and treatment. RESEARCH QUESTION: Is the novel "graded-stiffness" solution better able to redistribute heel pressure and reduce focal stress concentration areas of the heel? METHODS: Twenty healthy young men walked with four, 3D-printed, insole configurations. The configurations included the "graded-stiffness" insoles with and without an offloading hole under the heel tissue at risk for ulcerations and two conventional offloading supports of flat insoles with no offloading and simple holed offloading insoles. In-shoe plantar pressure was measured using the Pedar-X system. Peak pressure and pressure dose were measured at three heel regions: offloaded region, perimeter of offloaded region, and periphery region. RESULTS: The simple offloading configuration reduced pressure at the offloaded region; however, pressure at the perimeter of the offloading region significantly increased. With respect to ANOVA, the "graded-stiffness" offloading configurations were more effective than existing tested solutions in reducing and redistributing heel peak pressure and pressure dose, considering all heel regions. SIGNIFICANCE: The "graded-stiffness" offloading solution demonstrated a novel flexible and customized solution that can be manufactured on-demand through a precise selection of the graded-stiffness offloading location and material properties to fit the shape and size of the ulcer. This study is a follow-up in-vivo pilot study, in a healthy population group, to our previous computation modeling work that reported the efficiency of the "graded-stiffness" configuration, and which emphasizes its potential for streamlining and optimizing the prevention and treatment of diabetic heel ulcers.

Application of Artificial Intelligence Methodologies to Chronic Wound Care and Management: A Scoping Review.

Significance: As the number of hard-to-heal wound cases rises with the aging of the population and the spread of chronic diseases, health care professionals struggle to provide safe and effective care to all their patients simultaneously. This study aimed at providing an in-depth overview of the relevant methodologies of artificial intelligence (AI) and their potential implementation to support these growing needs of wound care and management. Recent Advances: MEDLINE, Compendex, Scopus, Web of Science, and IEEE databases were all searched for new AI methods or novel uses of existing AI methods for the diagnosis or management of hard-to-heal wounds. We only included English peer-reviewed original articles, conference proceedings, published patent applications, or granted patents (not older than 2010) where the performance of the utilized AI algorithms was reported. Based on these criteria, a total of 75 studies were eligible for inclusion. These varied by the type of the utilized AI methodology, the wound type, the medical record/database configuration, and the research goal. Critical Issues: AI methodologies appear to have a strong positive impact and prospects in the wound care and management arena. Another important development that emerged from the findings is AI-based remote consultation systems utilizing smartphones and tablets for data collection and connectivity. Future Directions: The implementation of machine-learning algorithms in the diagnosis and managements of hard-to-heal wounds is a promising approach for improving the wound care delivered to hospitalized patients, while allowing health care professionals to manage their working time more efficiently.

Effective negative pressure wound therapy for open wounds: The importance of consistent pressure delivery.

Two distinct design concepts exist for single-use negative pressure wound therapy systems: Canister-based versus canisterless. The canister-based technology provides intrinsic stable delivery of the intended negative pressure, because exudate is constantly transferred from the wound into a canister, thereby preventing dressing saturation. In contrast, with a canisterless system, where delivery of the negative pressure depends on continuous evaporation of wound fluids from its dressing, loss of the intended wound-bed pressure may occur due to dressing saturation. To investigate whether these two designs differ in their mechanobiological effect with respect to magnitudes and distributions of tissue strain fields under the absorptive dressing, termed the influence zone, we integrated computational modelling with an animal study. This influence zone must be of biologically influential strain levels and extend sufficiently into the peri-wound for stimulating fibroblasts to migrate and progress the healing. We found that an effective influence zone requires continuous delivery of the intended pressure to the wound-bed. Loss of negative pressure at the wound-bed below 40 mmHg adversely lowered the peri-wound stimulation around a 120 × 70 mm sized wound to less than one-third of the baseline stimulation, and further pressure decreases to 20 mmHg or lower resulted in complete lack of peri-wound mechano-stimulation.

Fluid handling performance of wound dressings tested in a robotic venous leg ulcer system under compression therapy.

We designed, developed, built, and utilised a robotic system of a leg with two venous leg ulcers for testing the fluid handling performance of three wound dressing types. The results showed that a foam-based dressing technology is inferior in fluid handling performance when applied to an exuding venous leg ulcer, such that the dressing needs to manage the exudate in a vertical configuration with respect to the ground, that is, so that gravity pulls the exudate to concentrate in a small region at the bottom of the dressing. Moreover, wound dressings containing superabsorbent polymers do not necessarily function equally in fluid handling for venous leg ulcer scenarios, as the extreme requirements from the dressing (to manage the viscous fluid of a vertical and typically highly-exuding wound) appear to distinguish between optimal and suboptimal product performances despite that the tested products contain a superabsorbent, theoretically lumping them together to belong to a so-called 'superabsorbent dressing category'. In other words, it is a false premise to categorise products from different manufacturers into families based on material contents, and then assume that their laboratory or clinical performance is equal, so that from this point they can be judged solely on the basis of price.