The skin microbiome of infected pressure ulcers: A review and implications for health professionals.

BACKGROUND: Pressure ulcers (PUs) are injuries resulting from ischaemia caused by prolonged compression or shear forces on the skin, adjacent tissues and bones. Advanced stages of PUs are associated with infectious complications and constitute a major clinical challenge, with high social and economic impacts in health care. GOALS: This study aims to identify and describe the relationship between PU risk factors, stages and anatomical locations, and the relevance of microbial cohabitation and biofilm growth. METHODS: The narrative review method to advocating a critical and objective analysis of the current knowledge on the topic was performed. Indexed databases and direct consultation to specialized and high-impact journals on the subject were used to extract relevant information, guided by co-authors. The Medical Subject Headings of pressure ulcer (or injury), biofilms, infection and other analogues terms were used. RESULTS: Development of PUs and consequent infection depends on several direct and indirect risk factors, including cutaneous/PU microbiome, microclimate and behavioural factors. Infected PUs are polymicrobial and characterized by biofilm-associated infection, phenotypic hypervariability of species and inherent resistance to antimicrobials. The different stages and anatomical locations also play an important role in their colonization. The prevention and monitoring of PUs remain crucial for avoiding the emergence of systemic infections and reducing health care-associated costs, improve the quality of life of patients and reduce the mortality-associated infected PUs.

Nurses' Strategies to Prevent and/or Decrease Work-Related Technostress: A Scoping Review.

Although there is evidence of the impact of technostress on nurses' physical and psychological well-being, there is no clear understanding of what strategies are used by nurses to prevent/decrease work-related technostress. Thus, we aim to map existing literature that describe the strategies used by nurses to prevent or decrease work-related technostress. This review followed the methodology proposed by the Joanna Briggs Institute for scoping reviews. Data analysis, extraction, and synthesis were performed by two independent reviewers. After contrasting the found literature with the inclusion criteria outlined, no studies were found that address our review question. Overall, we found that technostress is a broad concept, thus becoming difficult to define. Given the complexity and demands of the clinical settings where nurses work, it may be that other stressors are more commonly identified and reported in the literature.

Impact of safe nurse staffing on the quality of care in Portuguese public hospitals: A cross-sectional study.

AIM: To assess the impact of safe nurse staffing on the quality of care, based on the structure-process-outcome approach, in Portuguese hospitals. BACKGROUND: Safe nurse staffing is essential for the quality of care in hospital settings, together with work environment, organisational commitment and nursing practices. However, there is little evidence of its analysis in the Portuguese context. METHOD: A cross-sectional survey study was conducted using a sample of 850 nurses from 12 public hospital units in the central and northern regions of Portugal. RESULTS: The proposed structural equation model for quality assessment has a good fit (χ2 /df = 2.37; CFI = 0.88, PCFI = 0.83; PGFI = 0.77, RMSEA = 0.04), showing the impact of safe nurse staffing, work environment, and affective and normative organisational commitment on the quality of care (mortality rate and adverse events). The mediating effect of nursing practices was also found. CONCLUSION: Safe nurse staffing, which is compromised in 90% of the units, is a predictor of the quality of care through the mediating effect of nursing practices. IMPLICATIONS FOR NURSING MANAGEMENT: The results not only highlight the need for urgent intervention but also support political decision-making with a view to improving the access to quality care.

Nurse staffing in Portuguese public hospitals.

AIM: This study aims to contribute to the knowledge of nurse staffing in hospital settings in central and northern Portugal. BACKGROUND: Nurse staffing is a critical factor for the quality and safety of health care and is still an understudied topic in Portugal. METHOD: A cross-sectional study was conducted with a sample of 850 nurses from 12 public hospitals in the central and northern regions of Portugal. RESULTS: Nurse staffing in these hospital units is insufficient, especially in internal medicine units and central hospitals. Nurses' perceptions are in line with the objective data. CONCLUSIONS: The shortage of nurses is a horizontal issue that is especially serious in internal medicine units and central hospitals and a potential threat to the quality of care. IMPLICATIONS FOR NURSING MANAGEMENT: The results stress the need for an urgent leadership intervention in nurse staffing levels in the hospitals analysed in this study. Contextual knowledge about nurse staffing is essential for decision-making and supporting health and human resource management policies.

Nurse managers' perceptions of nurse staffing and nursing care quality: A cross-sectional study.

AIM: To verify the association between the nurse staffing and the quality of nursing care, mediated by the care process, based on a hypothetical model, in Portuguese public hospitals. BACKGROUND: Nurse staffing influences health outcomes. Understaffing is associated with an increased risk for adverse events (AEs) and a reduction in the quality of care. METHOD: A cross-sectional study was conducted using a sample of 55 Portuguese nurse managers. A path model was developed to analyse potential causal mediation effects on care quality. RESULTS: Nurse staffing (number and competencies) and teamwork indirectly influence the quality of care. This process is mediated by the response capacity, the use of new techniques and work methods and patient's surveillance capacity. The AEs occurrence also has a mediating role, being negatively associated with the quality of care. CONCLUSIONS: Optimizing nursing care safety and quality requires an adequate nurse staffing level, both in terms of number and competencies, as well as teamwork. Process components seem to play a mediating role in these relations. IMPLICATIONS FOR NURSING MANAGEMENT: These results deserve the attention of nursing management for investment in the nursing staff and in the care process, to improve quality and create value in health care.

Practice environment scale of the nursing work index: Portuguese version and psychometric properties.

AIM: To assess the psychometric properties regarding the Portuguese version of the Practice Environment Scale of the Nursing Work Index. BACKGROUND: The Practice Environment Scale of the Nursing Work Index is the most widely used measure for assessing the practice environment. A model with a higher number of factors appears to be more adequate to Portuguese settings. METHOD: A confirmatory factor analysis was performed to the Practice Environment Scale of the Nursing Work Index using a sample of 850 Portuguese nurses. Three models were tested: the original model, a seven-factor model and a higher-order model. An analysis of invariance was performed in two subsets to confirm the stability of the solution. RESULTS: The seven-factor model fit better to the data than the original model. After refinement, this solution showed suitability and a stable factor structure. Reliability, convergent validity and discriminant validity were confirmed. A second-order factor solution also showed suitability. CONCLUSION: The seven-factor structure of the Practice Environment Scale of the Nursing Work Index showed a better goodness-of-fit to Portuguese settings than the original structure. The second-order factor solution allows an overall assessment of practice environments. IMPLICATIONS FOR NURSING MANAGEMENT: The Portuguese version of the Practice Environment Scale of the Nursing Work Index is a valuable tool for assessing Portuguese nursing practice environments. The seven-factor solution of the Practice Environment Scale of the Nursing Work Index showed high specificity.

On the utility of 3D hand cursors to explore medical volume datasets with a touchless interface.

Analyzing medical volume datasets requires interactive visualization so that users can extract anatomo-physiological information in real-time. Conventional volume rendering systems rely on 2D input devices, such as mice and keyboards, which are known to hamper 3D analysis as users often struggle to obtain the desired orientation that is only achieved after several attempts. In this paper, we address which 3D analysis tools are better performed with 3D hand cursors operating on a touchless interface comparatively to a 2D input devices running on a conventional WIMP interface. The main goals of this paper are to explore the capabilities of (simple) hand gestures to facilitate sterile manipulation of 3D medical data on a touchless interface, without resorting on wearables, and to evaluate the surgical feasibility of the proposed interface next to senior surgeons (N=5) and interns (N=2). To this end, we developed a touchless interface controlled via hand gestures and body postures to rapidly rotate and position medical volume images in three-dimensions, where each hand acts as an interactive 3D cursor. User studies were conducted with laypeople, while informal evaluation sessions were carried with senior surgeons, radiologists and professional biomedical engineers. Results demonstrate its usability as the proposed touchless interface improves spatial awareness and a more fluent interaction with the 3D volume than with traditional 2D input devices, as it requires lesser number of attempts to achieve the desired orientation by avoiding the composition of several cumulative rotations, which is typically necessary in WIMP interfaces. However, tasks requiring precision such as clipping plane visualization and tagging are best performed with mouse-based systems due to noise, incorrect gestures detection and problems in skeleton tracking that need to be addressed before tests in real medical environments might be performed.

Impact of a structured multicomponent educational intervention program on metabolic control of patients with type 2 diabetes.

BACKGROUND: Diabetes is one of the most common metabolic disorders, with a high prevalence of patients with poor metabolic control. Worldwide, evidence highlights the importance of developing and implementing educational interventions that can reduce this burden. The main objective of this study was to analyse the impact of a lifestyle centred intervention on glycaemic control of poorly controlled type 2 diabetic patients, followed in a Community Care Centre. METHODS: A type 2 experimental design was conducted over 6 months, including 122 adults with HbA1c ≥ 7.5%, randomly allocated into Experimental group (EG) or Control Group (CG). EG patients attended a specific Educational Program while CG patients frequented usual care. Personal and health characterization variables, clinical metrics and self-care activities were measured before and after the implementation of the intervention. Analysis was done by comparing gains between groups (CG vs EG) through differential calculations (post minus pre-test results) and Longitudinal analysis. RESULTS: Statistical differences were obtained between groups for HbA1c and BMI: EG had a decrease in 11% more (effect-size r2 = .11) than CG for HbA1c (p < .001) and 4% more (effect-size r2 = .04) in BMI (p < .05). When controlling for socioeconomic characteristics and comorbidities that showed to be associated to each parameter in pre-test, from pre to post-test only EG participants significantly decreased HbA1c [Wilks' ʎ = .702; F(1,57) = 24.16; p < .001; ηp2 = .298; observed power = .998]; BMI values [Wilks' ʎ = .900; F(1,59) = 6.57; p = .013; ηp2 = .100; observed power = .713]; systolic Blood pressure [Wilks' ʎ = .735; F(1,61) = 21.94; p < .001; ηp2 = .265; observed power = .996] and diastolic Blood pressure [Wilks' ʎ = .795; F(1,59) = 15.20; p < .001; ηp2 = .205; observed power = .970]. CONCLUSIONS: The impact of a structured multicomponent educational intervention program by itself, beyond standard educational approach alone, supported in a Longitudinal analysis that controlled variables statistically associated with clinical metrics in pre-test measures, has demonstrated its effectiveness in improving HbA1c, BMI and Blood pressure values. TRIAL REGISTRATION: RBR-8ns8pb . (Retrospectively registered: October 30,2017).

Dynamical Torque in CoxFe3-xO4 Nanocube Thin Films Characterized by Femtosecond Magneto-Optics: A π-Shift Control of the Magnetization Precession.

For spintronic devices excited by a sudden magnetic or optical perturbation, the torque acting on the magnetization plays a key role in its precession and damping. However, the torque itself can be a dynamical quantity via the time-dependent anisotropies of the system. A challenging problem for applications is then to disentangle the relative importance of various sources of anisotropies in the dynamical torque, such as the dipolar field, the crystal structure or the shape of the particular interacting magnetic nanostructures. Here, we take advantage of a range of colloidal cobalt ferrite nanocubes assembled in 2D thin films under controlled magnetic fields to demonstrate that the phase, ϕPrec, of the precession carries a strong signature of the dynamical anisotropies. Performing femtosecond magneto-optics, we show that ϕPrec displays a π-shift for a particular angle θH of an external static magnetic field, H. θH is controlled with the cobalt concentration, the laser intensity, as well as the interparticle interactions. Importantly, it is shown that the shape anisotropy, which strongly departs from those of equivalent bulk thin films or individual noninteracting nanoparticles, reveals the essential role played by the interparticle collective effects. This work shows the reliability of a noninvasive optical approach to characterize the dynamical torque in high density magnetic recording media made of organized and interacting nanoparticles.

The invisibility of the cognitive cost of military police work.

OBJECTIVE: To assess the cognitive cost of work for military police officers in the state of Rio de Janeiro. METHOD: This is a cross-sectional study with a quantitative approach, carried out with 446 military police officers, of both sexes, distributed between non-commissioned officers and officers, in the 7th, 15th, 20th, 24th and 41st Military Police Battalions. An instrument was used to depict sociodemographic, work, lifestyle and health conditions and a scale for assessing the human cost of work, which analyses the demands of the job through physical, cognitive and affective costs. The data was organized, processed and analyzed using the Statistical Package for the Social Sciences (SPSS) software, version 13.1. RESULTS: The cognitive cost had the highest means, with severe results (µ = 3.86; SD = 0.86), representing greater demands in relation to the human cost of work among military police officers in the state of Rio de Janeiro and significant associations in relation to obesity, cognitive alterations in attention and memory, age and hours of sleep. CONCLUSION: In assessing the human cost of work, the cognitive cost was the most demanding in the work context of the military police officers surveyed, presenting a serious risk of illness.

A three step protocol for the development of an innovative footwear (shoe and sensor based insole) to prevent diabetic foot ulceration.

Background: The incidence of diabetic foot ulceration (DFU) is increasing worldwide. Therapeutic footwear is usually recommended in clinical practice for preventing foot ulcers in persons with diabetes. The project Science DiabetICC Footwear aims to develop innovative footwear to prevent DFU, specifically a shoe and sensor-based insole, which will allow for monitoring pressure, temperature, and humidity parameters. Method: This study presents a three-step protocol for the development and evaluation of this therapeutic footwear, specifically: (i) a first observational study will specify the user requirements and contexts of use; (ii) after the design solutions were developed for shoe and insole, the semi-functional prototypes will be evaluated against the initial requirements; (iii) and a pre-clinical study protocol will enable the evaluation of the final functional prototype. The eligible diabetic participants will be involved in each stage of product development. The data will be collected using interviews, clinical evaluation of the foot, 3D foot parameters and plantar pressure evaluation. This three-step protocol was defined according to the national and international legal requirements, ISO norms for medical devices development, and was also reviewed and approved by the Ethics Committee of the Health Sciences Research Unit: Nursing (UICISA: E) of the Nursing School of Coimbra (ESEnfC). Results: The involvement of end-users (diabetic patients) will enable the definition of user requirements and contexts of use to develop design solutions for the footwear. Those design solutions will be prototyped and evaluated by end-users to achieve the final design for therapeutic footwear. The final functional prototype will be evaluated in pre-clinical studies to ensure that the footwear meets all the requirements to move forward to clinical studies. Discussion: The three-step study outlined in this protocol will provide the necessary insights during the product development, ensuring this new therapeutic footwear's main functional and ergonomic features for DFU prevention.

Foot and Ankle Disorders in Nurses Exposed to Prolonged Standing Environments: A Scoping Review.

BACKGROUND: Prolonged standing environments constitute an occupational risk factor for nurses, particularly for developing foot and ankle disorders. The definitions and potential relationship to hours spent walking or standing are poorly understood. This scoping review aimed to synthesize the main disorders found on nurses' ankles and feet, their prevalence, the influence of hours spent walking or standing, and gender differences. METHODS: This review followed a previously published protocol. Primary and secondary studies were retrieved from relevant databases from December 2020 to March 2021. Potential articles were collated to Mendeley, and two independent reviewers assessed the title and abstracts. Studies meeting inclusion criteria were included. Two researchers retrieved and reviewed the full text of these studies independently. A predetermined extraction tool was used to retrieve relevant data, summarized in a tabular and narrative format. FINDINGS: The most common disorder was pain, followed by numbness, burning feet, bunions, structural deformities, and calluses. Prevalence differed among studies, depending on settings and specific local policies. Discussion: Various foot and ankle disorders and related variables have been found, with clear gaps that may be addressed in the future. CONCLUSION/APPLICATIONS TO PRACTICE:: Few studies have focused on nurses' foot and ankle disorders. Mapping signs and symptoms may contribute to the future development of preventive interventions for nurses' workplaces.

Short Peripheral Venous Catheters Contamination and the Dangers of Bloodstream Infection in Portugal: An Analytic Study.

Peripheral venous catheters (PVCs) are the most used vascular access devices in the world. However, failure rates remain considerably high, with complications such as PVC-related infections posing significant threats to patients' well-being. In Portugal, studies evaluating the contamination of these vascular medical devices and characterizing the associated microorganisms are scarce and lack insight into potential virulence factors. To address this gap, we analyzed 110 PVC tips collected in a large tertiary hospital in Portugal. Experiments followed Maki et al.'s semi-quantitative method for microbiological diagnosis. Staphylococcus spp. were subsequently studied for the antimicrobial susceptibility profile by disc diffusion method and based on the cefoxitin phenotype, were further classified into strains resistant to methicillin. Screening for the mecA gene was also done by a polymerase chain reaction and minimum inhibitory concentration (MIC)-vancomycin as determined by E-test, proteolytic and hemolytic activity on skimmed milk 1% plate and blood agar, respectively. The biofilm formation was evaluated on microplate reading through iodonitrotetrazolium chloride 95% (INT). Overall, 30% of PVCs were contaminated, and the most prevalent genus was Staphylococcus spp., 48.8%. This genus presented resistance to penicillin (91%), erythromycin (82%), ciprofloxacin (64%), and cefoxitin (59%). Thus, 59% of strains were considered resistant to methicillin; however, we detected the mecA gene in 82% of the isolates tested. Regarding the virulence factors, 36.4% presented α-hemolysis and 22.7% ß-hemolysis, 63.6% presented a positive result for the production of proteases, and 63.6% presented a biofilm formation capacity. Nearly 36.4% were simultaneously resistant to methicillin and showed expression of proteases and/or hemolysins, biofilm formation, and the MIC to vancomycin were greater than 2 µg/mL. Conclusion: PVCs were mainly contaminated with Staphylococcus spp., with high pathogenicity and resistance to antibiotics. The production of virulence factors strengthens the attachment and the permanence to the catheter's lumen. Quality improvement initiatives are needed to mitigate such results and enhance the quality and safety of the care provided in this field.

Nursing Practices and Sensitive Outcomes Related to Peripheral Intravenous Catheterization in Portugal: A Scoping Review.

Implementation of evidence-based practice (EBP) is essential for ensuring high-quality nursing care. In Portugal, nurses are responsible for care delivery to patients who require peripheral intravenous access. However, recent authors emphasized the predominance of a culture based on outdated professional vascular access practices in Portuguese clinical settings. Thus, the aim of this study was to map the studies conducted in Portugal on peripheral intravenous catheterization. A scoping review was conducted based on the Joanna Briggs Institute recommendations, with a strategy adapted to different scientific databases/registers. Independent reviewers selected, extracted, and synthesized the data. Of the 2128 studies found, 26 were included in this review, published between 2010 and 2022. Previous research shows that Portuguese nurses' implementation of EBP was found to be relatively low overall, while most studies did not attempt to embed EBP change into routine care. Although nurses are responsible for implementing EBP at an individual patient level, the studies conducted in Portugal report nonstandardized practices among professionals, with significant deviations from recent evidence. This reality, combined with Portugal's absence of government-endorsed evidence-based standards for peripheral intravenous catheter (PIVC) insertion and treatment and vascular access teams, may explain the country's unacceptably high incidence of PIVC-related complications reported over the last decade.

Portuguese translation, cultural adaptation, and validation of the Person-Centred Practice Inventory - Staff (PCPI-S).

Aiming to translate, culturally adapt, and psychometrically evaluate the Person-centred Practice Inventory - Staff (PCPI-S) for Portuguese healthcare professionals, this methodological study was conducted sequentially in two phases. Phase I followed the 10-steps recommendations from the ISPOR taskforce for translation and cultural adaptation of patient reported outcome measures. Phase II comprised a quantitative cross-sectional virtual survey of the translated PCPI-S with healthcare professionals, who were reached through snowball sampling from both primary and specialized care settings. The psychometric properties of the PCPI-S were determined by assessing reliability and construct validity. A sample of 304 healthcare professionals participated in Phase II. Ceiling effects were found. The overall internal consistency was excellent (> 0.9). The confirmatory factor analysis showed a good model fit after minor modifications, revealing construct validity, and supporting the theoretical framework. In conclusion, the three-factorial model of PCPI-S adjusted to the studied sample is a valid and reliable instrument to assess the perceptions of healthcare professionals on person-centred practice in various Portuguese clinical contexts. Considering the ceiling effects, the effect of social desirability should be explored.

Flushing in Intravenous Catheters: Observational Study of Nursing Practice in Intensive Care in Brazil.

An observational study was developed with 108 nursing professionals who managed vascular access devices in 4 intensive care units of a university hospital in Rio de Janeiro, Brazil. The objective was to analyze the practice of the nursing staff in performing flushing for the maintenance of vascular access devices in critically ill patients. Data were collected by observing the flushing procedure using a structured checklist and analyzed using descriptive and inferential statistics. In 23% of the 404 observations, there was no flushing. When performed at some point during catheter management (77%), flushing was predominant after drug administration with 1 or 2 drugs administered. There were flaws in the flushing technique applied in terms of volume and method of preparation. Time of professional experience >5 years, knowledge about recommendations, and training on flushing were variables associated with technique performance. It was concluded that the flushing procedure did not meet the recommendations of good practices, with failures that constituted medication errors.

Repercussions of sickle cell disease and sickle cell ulcers for men inserted in the world of work.

OBJECTIVE: To analyze the repercussions of sickle cell disease and sickle cell ulcer for men in the world of work and discuss the challenges faced to remain in the work environment. METHOD: A qualitative study, developed at the dressing clinic and at a stomatherapy clinic. Twenty men with sickle cell disease and sickle cell ulcer participated, applying a semi-structured interview script. The software Interface de R pour les Analyses Multidimensionnelles de Textes et de Questionnaires was used for treatment and lexical data analysis. RESULTS: The Descending Hierarchical Classification enabled the creation of classes: Man with sickle cell disease and sickle cell ulcer: experiences and repercussions; and Coping measures adopted by men with sickle cell disease and sickle cell ulcer to stay at work. CONCLUSION: Disease and injury repercussions involve biopsychosocial dimensions, highlighting the need for professional training to assist with competence and humanity. Strategies adopted to maintain work are breaks in the working day, use of analgesics to relieve pain, allocating time during work to apply dressings.

Design of Innovative Clothing for Pressure Injury Prevention: End-User Evaluation in a Mixed-Methods Study.

The global relevance of pressure injury (PI) prevention technologies arise from their impact on the quality of life of people with limited mobility and the costs associated with treating these preventable injuries. The purpose of this mixed methods study is to evaluate the design of a prototype integrating Smart Health Textiles for PI prevention based on feedback from specialist nurses who care for individuals who are prone to or have PIs. This is a mixed methods study. A structured questionnaire was conducted as part of an evaluation of a prototype garment for the prevention of PIs. This questionnaire was applied during the evaluation of the prototype and afterwards focus group discussions were held with experts. Descriptive statistics techniques were used to analyze the data and thematic and integrated content analysis was conducted through concomitant triangulation. Nineteen nurses took part, aged 30 to 39 years (52.6%) and with 12.31 ± 8.96 years of experience. Participants showed that the prototype required more manipulation and physical effort, which interfered its usefulness, in addition to presenting difficulties with the openings and the material of the closure system, which interfered with the ease of use and learning. Overall satisfaction with the product was moderate, with some areas for improvement found, such as satisfaction, recommendations to colleagues, and pleasantness of use. It is concluded that areas for improvement have been found in all dimensions, including in the design of openings and the choice of materials. These findings supply significant insights for improving clothing to meet the needs of healthcare professionals and patients.

End-User Assessment of an Innovative Clothing-Based Sensor Developed for Pressure Injury Prevention: A Mixed-Method Study.

This study aimed to evaluate a clothing prototype that incorporates sensors for the evaluation of pressure, temperature, and humidity for the prevention of pressure injuries, namely regarding physical and comfort requirements. A mixed-method approach was used with concurrent quantitative and qualitative data triangulation. A structured questionnaire was applied before a focus group of experts to evaluate the sensor prototypes. Data were analyzed using descriptive and inferential statistics and the discourse of the collective subject, followed by method integration and meta-inferences. Nine nurses, experts in this topic, aged 32.66 ± 6.28 years and with a time of profession of 10.88 ± 6.19 years, participated in the study. Prototype A presented low evaluation in stiffness (1.56 ± 1.01) and roughness (2.11 ± 1.17). Prototype B showed smaller values in dimension (2.77 ± 0.83) and stiffness (3.00 ± 1.22). Embroidery was assessed as inadequate in terms of stiffness (1.88 ± 1.05) and roughness (2.44 ± 1.01). The results from the questionnaires and focus groups' show low adequacy as to stiffness, roughness, and comfort. The participants highlighted the need for improvements regarding stiffness and comfort, suggesting new proposals for the development of sensors for clothing. The main conclusions are that Prototype A presented the lowest average scores relative to rigidity (1.56 ± 1.01), considered inadequate. This dimension of Prototype B was evaluated as slightly adequate (2.77 ± 0.83). The rigidity (1.88 ± 1.05) of Prototype A + B + embroidery was evaluated as inadequate. The prototype revealed clothing sensors with low adequacy regarding the physical requirements, such as stiffness or roughness. Improvements are needed regarding the stiffness and roughness for the safety and comfort characteristics of the device evaluated.

Development of Smart Clothing to Prevent Pressure Injuries in Bedridden Persons and/or with Severely Impaired Mobility: 4NoPressure Research Protocol.

Pressure injuries (PIs) are a major public health problem and can be used as quality-of-care indicators. An incipient development in the field of medical devices takes the form of Smart Health Textiles, which can possess innovative properties such as thermoregulation, sensing, and antibacterial control. This protocol aims to describe the process for the development of a new type of smart clothing for individuals with reduced mobility and/or who are bedridden in order to prevent PIs. This paper's main purpose is to present the eight phases of the project, each consisting of tasks in specific phases: (i) product and process requirements and specifications; (ii and iii) study of the fibrous structure technology, textiles, and design; (iv and v) investigation of the sensor technology with respect to pressure, temperature, humidity, and bioactive properties; (vi and vii) production layout and adaptations in the manufacturing process; (viii) clinical trial. This project will introduce a new structural system and design for smart clothing to prevent PIs. New materials and architectures will be studied that provide better pressure relief, thermo-physiological control of the cutaneous microclimate, and personalisation of care.