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 performance of gelling fibre wound dressings under clinically relevant robotic laboratory tests.

The effectiveness of wound dressing performance in exudate management is commonly gauged in simple, non-realistic laboratory setups, typically, where dressing specimens are submersed in vessels containing aqueous solutions, rather than by means of clinically relevant test configurations. Specifically, two key fluid-structure interaction concepts: sorptivity-the ability of wound dressings to transfer exudate, including viscous fluids, away from the wound bed by capillary action and durability-the capacity of dressings to maintain their structural integrity over time and particularly, at removal events, have not been properly addressed in existing test protocols. The present article reviews our recent published research concerning the development of clinically relevant testing methods for wound dressings, focussing on the clinical relevance of the tests as well as on the standardisation and automation of laboratory measurements of dressing performance. A second objective of this work was to compile the experimental results characterising the performance of gelling fibre dressings, which were acquired using advanced testing methods, to demonstrate differences across products that apparently belong to the same "gelling fibre" family but differ remarkably in materials, structure and composition and, thereby, in performance.

Skin damage prevention in the prone ventilated critically ill patient: A comprehensive review and gap analysis (PRONEtect study).

BACKGROUND: Ventilating critically ill patients with acute respiratory distress syndrome in the prone position is a life-saving strategy, but it is associated with adverse consequences such as skin damage. AIM: To identify, review and evaluate international proning and skin care guidelines and make an inventory of commonly used equipment and training resources. DESIGN: A gap analysis methodology was applied. METHODS: 1) Comprehensive search and evaluation of proning and skin care guidelines, 2) extensive search and listing equipment and educational resources, and 3) international consultation with 11 experts (8 countries). DATA SOURCES: A variety of sources researched through July 2021 were used to identify relevant literature: (1) scientific literature databases and clinical trials registries, (2) intensive care and wound care associations, (3) healthcare organisations, (4) guideline development organisations, and (5) the Google search engine. Eleven international experts reviewed the literature and provided insights in two, 2-h online sessions. FINDINGS: The search yielded 24 guidelines. One clinical practice guideline had high methodological quality. Twenty-five devices/equipment and sixteen teaching materials were identified and discussed with the expert panel. The gap analysis identified a lack of concise, accessible, evidence-based guidelines and educational materials of short duration. CONCLUSION: This analysis forms the basis for designing a competency-based education and training intervention for an interdisciplinary team caring for the skin of critically ill patients in the prone position. IMPACT: The results can assist the multidisciplinary team to review their current protocol for prone positioning. This is a first step in developing a training package for clinicians.

Medical device-related pressure ulcers and the COVID-19 pandemic: from aetiology to prevention

This article describes the aetiology of medical device-related pressure ulcers (MDRPU) and the vicious cycle that leads to these (typically, hospital-acquired) injuries. In this cycle, the primary, deformation-inflicted cell damage leads to a secondary inflammatory oedema-related damage and then to tertiary ischaemic cell and tissue damage. These three damage factors act cumulatively, and, once the first deformation-inflicted massive cell death initiates in the distorted tissues, each of these factors escalates the cell death and tissue damage further, under and near the applied medical device. The primary pathophysiological factors of the COVID-19 pandemic -- including the cytokine storm, hypoxia and hyper-coagulation, which are typical to seriously ill patients who require life-support (skin-contacting) medical devices -- can fuel the damage spiral of pressure injury. A continuous positive airway pressure (CPAP) mask is a classic example of a commonly used medical device (especially in treating patients with COVID-19 virus who present with breathing problems), which is often the cause of a MDRPU, as it applies intense, localised mechanical loads onto the facial skin and within underlying soft tissues. Moreover, the affected facial soft tissues cannot swell in response to the inflammatory oedema that typically develops under the mask, as they are sandwiched between the device and the skull. It is possible to lower the risk of a CPAP-caused MDRPU, particularly through appropriate selection and application of prophylactic dressings under the CPAP mask, primarily in order to alleviate and disperse the localised soft tissue loads. Other than alleviating the sustained, localised mechanical loads in the affected tissues (i.e. the tissue stress concentrations), such prophylactic interventions must minimise the heat accumulation on and within skin and reduce the exposure of skin to shearing forces. Understanding the aetiology of MDRPUs targets and focuses effective clinical interventions. An informed selection of a prophylactic dressing technology, based on bioengineering testing, is different from making non-evidence -based choices, such as selection of hydrocolloid materials, which are relatively stiff and are not conducive to tissue load alleviation.

The aetiology of medical device-related pressure ulcers and how to prevent them.

This article provides an introduction to the aetiology of medical device-related pressure ulcers (MDRPUs), describes the vicious cycle that leads to these injuries and highlights bioengineering methodologies and findings that connect the aetiology to the clinical practice of preventing MDRPUs. Specifically, the vicious cycle of MDRPUs is triggered by the sustained tissue deformations induced by a skin-contacting device. The primary, deformation-inflicted cell damage leads to a secondary inflammatory-oedema-related damage and then to tertiary ischaemic damage. Each of these three factors contributes to cumulative cell death and tissue damage under and near the applied device. The damage therefore develops in an escalated manner, as a result of the added contributions of the above three factors. This phenomenon is exemplified through two common clinical scenarios. First, through the use of continuous positive airway pressure (CPAP) masks, which are being applied extensively in the current COVID-19 pandemic, and, second, through the use of doughnut-shaped head positioners, which are applied to surgical patients and sometimes to bedridden individuals who receive intensive care in a supine position. These two medical devices cause intense, localised mechanical loads in the facial skin and underlying tissues (CPAP mask) and at the occipital scalp (doughnut-shaped positioner), where the soft tissues cannot swell in response to the inflammatory oedema as, in both cases, the tissues are sandwiched between the device and the skull. Accordingly, the two device types result in characteristic MDRPUs that are avoidable through appropriate prophylactic interventions, that is, preventive dressings under the CPAP mask and replacement of the doughnut device by a soft, shape-conforming support aid to alleviate and disperse the localised soft tissue deformations. Hence, understanding the aetiology of MDRPUs targets and focuses effective clinical interventions.

Skin Tears, Medical Face Masks, and Coronavirus

Gefen expresses insights about skin tears, medical face masks, and coronavirus. The International Consensus Document on Device-related Pressure Injuries (DRPIs), developed over a year of intense work by a global multidisciplinary expert group, is a comprehensive synthesis of contemporary scientific and clinical knowledge regarding tissue damage that can be caused by medical devices. The international consensus document discusses the role of frictional forces in DRPIs in detail. Generally, frictional forces caused by medical devices (or other objects in contact with skin) distort cells and tissues, resulting in sustained shear that leads to skin and subdermal tissue damage. It describes the damage cascade in cells and tissues, particularly in the context of ventilation masks, tissue damage similar to that caused by prolonged use of medical face masks.

Protecting prone positioned patients from facial pressure ulcers using prophylactic dressings: A timely biomechanical analysis in the context of the COVID-19 pandemic.

Prone positioning is used for surgical access and recently in exponentially growing numbers of coronavirus disease 2019 patients who are ventilated prone. To reduce their facial pressure ulcer risk, prophylactic dressings can be used; however, the biomechanical efficacy of this intervention has not been studied yet. We, therefore, evaluated facial soft tissue exposures to sustained mechanical loads in a prone position, with versus without multi-layered silicone foam dressings applied as tissue protectors at the forehead and chin. We used an anatomically realistic validated finite element model of an adult male head to determine the contribution of the dressings to the alleviation of the sustained tissue loads. The application of the dressings considerably relieved the tissue exposures to loading. Specifically, with respect to the forehead, the application of a dressing resulted in 52% and 71% reductions in soft tissue exposures to effective stresses and strain energy densities, respectively. Likewise, a chin dressing lowered the soft tissue exposures to stresses and strain energy densities by 78% and 92%, respectively. While the surgical context is clear and there is a solid, relevant need for biomechanical information regarding prophylaxis for the prone positions, the projected consequences of the coronavirus pandemic make the present work more relevant than ever before.

Update to device-related pressure ulcers: SECURE prevention. COVID-19, face masks and skin damage

The 2019 novel coronavirus disease (COVID-19) pandemic has brought the effects of device-related pressure ulcers (DRPU) into sharp focus. With the increased use of personal protective equipment (PPE), including face masks, continuous positive airway pressure (CAPP) masks and other devices, the incidence of DRPUs among health professionals and patients alike has risen starkly. As such, the Journal of Wound Care (JWC) consensus document, Device-related pressure ulcers: SECURE prevention, published in February 2020, is more relevant than ever. To help support patients and frontline health professionals, JWC is republishing the consensus in a digital format, along with a new introductory article outlining the DRPU risks posed by PPE and other medical devices used by patients and health professionals during the pandemic, and how the skin damage can be avoided. The aim is to provide frontline staff with a clear, simple strategy on how to prevent the risk of personal skin damage and/or DRPU during the pandemic, as well as point them in the direction of more indepth guidance on long-term strategies for prevention, for both themselves and patients.