Review of Medical Adhesive Technology in the Context of Medical Adhesive-Related Skin Injury.

In clinical practice, a large variety of medical devices adhere to skin to perform their function. The repeated application and removal of these devices can lead to skin damage or medical adhesive-related skin injury. Awareness of this problem has increased in the past decade, and this adverse event can be prevented with appropriate selection of adhesive products and the appropriate techniques for application and removal. A wide variety of adhesives and backing systems have been developed to create medical devices with an array of attributes, so they can accomplish many different indications in the clinical setting and meet various needs, including doing the clinical job without damaging the skin and causing further patient complications. The selection of an adhesive product should take into consideration a patient's skin assessment and history of medical adhesive-related skin injury, and using only the minimal adhesive strength needed to perform the function while protecting the skin from damage.

The uptake of the international pressure ulcer/injury prevention and treatment guidelines: An updated systematic citation analysis.

The European Pressure Ulcer Advisory Panel, National Pressure Injury Advisory Panel, and Pan Pacific Pressure Injury Alliance collaboratively developed three editions of the International Clinical Practice Guidelines for preventing and treating pressure ulcers/injuries in 2009, 2014, and 2019. Dissemination and uptake of these guidelines are important to improve care. The aim of this work was to provide an updated and expanded citation analysis of the three published guidelines. Referencing formats, citation counts, and global distribution of citations of the 2009, 2014, and 2019 guidelines were searched in the citation database Scopus from 2009 to 2023. Duplicates were removed manually. The search identified 330 referencing formats with 2887 citations from 2009 to 2023 for the three guideline editions. Citations displayed geographical diversity, with citation peaks observed approximately 4 years after each edition's release and ongoing citations to the present. The International Clinical Practice Guidelines for preventing and treating pressure ulcers/injuries updated since 2009 were cited more than 2800 times in the scientific literature exceeding the thresholds of highly cited papers in the field of clinical medicine. This indicates successful dissemination worldwide.

Prognostic factors for the development of incontinence-associated dermatitis (IAD): A systematic review.

Incontinence-associated dermatitis (IAD) is an irritant contact dermatitis from prolonged contact with urine or faeces, which can significantly impact patient comfort and quality of life. The identification of prognostic factors for the development of IAD has the potential to enhance management, support preventive measures and guide future research. The objective of this systematic review was to summarize the empirical evidence of prognostic factors for the development of IAD. This study included prospective and retrospective observational studies or clinical trials that described prognostic factors associated with IAD. There were no restrictions on setting, time, language, participants or geographical regions. Exclusion criteria included reviews, editorials, commentaries, methodological articles, letters to the editor, cross-sectional and case-control studies, and case reports. Searches were conducted from inception to April 2024 on MEDLINE, CINAHL, EMBASE and the Cochrane Library. The studies were assessed by two independent reviewers using the QUIPS and the CHARMS-PF for data extraction. A narrative synthesis approach was employed due to study heterogeneity and using the 'vote counting based on direction' method and the sign test. The overall certainty of evidence was assessed using adapted GRADE criteria. The review included 12 studies and identified 15 potential predictors. Moderate-quality evidence suggests that increased stool frequency, limited mobility and friction/shear problems are risk factors for IAD development. Female sex, older age, vasopressor use and loose/liquid stool are risk factors supported by low-quality evidence. Increased stool frequency, limited mobility and friction/shear problems seem to be risk factors for the development of IAD. There is insufficient evidence to support the predictive validity of female sex, older age, loose/liquid stool and vasopressor use. There is substantial methodological variability across studies, making it challenging to make comparisons. Large-scale cohort studies in different settings that incorporate our review findings should be conducted in the future.

Effects of a mattress cover with special airflow technology on the structure and function of the sacral and heel skin during loading: A two-arm exploratory crossover trial.

Prolonged mechanical loading of the skin and underlying soft tissue cause pressure ulceration. The use of special support surfaces are key interventions in pressure ulcer prevention. They modify the degree and duration of soft tissue deformation and have an impact on the skin microclimate. The objective of this randomized cross-over trial was to compare skin responses and comfort after lying for 2.5 h supine on a support surface with and without a coverlet that was intended to assist with heat and moisture removal at the patient/surface interface. In addition, physiological saline solution was administered to simulate an incontinence episode on the mattress next to the participants' skin surface. In total, 12 volunteers (mean age 69 years) with diabetes mellitus participated. After loading, skin surface temperature, stratum corneum hydration and skin surface pH increased, whereas erythema and structural stiffness decreased at the sacral area. At the heel skin area, temperature, erythema, and stratum corneum hydration increased. These results indicate occlusion and soft tissue deformation which was aggravated by the saline solution. The differences in skin response showed only minor differences between the support surface with or without the coverlet.

Skin health of community-living older people: a scoping review.

The population of older people is steadily increasing and the majority live at home. Although the home and community are the largest care settings worldwide, most of the evidence on dermatological care relates to secondary and tertiary care. The overall aims were to map the available evidence regarding the epidemiology and burden of the most frequent skin conditions and regarding effects of screening, risk assessment, diagnosis, prevention and treatment of the most frequent skin conditions in older people living in the community. A scoping review was conducted. MEDLINE, Embase and Epistemonikos were systematically searched for clinical practice guidelines, reviews and primary studies, as well as Grey Matters and EASY for grey literature published between January 2010 and March 2023. Records were screened and data of included studies extracted by two reviewers, independently. Results were summarised descriptively. In total, 97 publications were included. The vast majority described prevalence or incidence estimates. Ranges of age groups varied widely and unclear reporting was frequent. Sun-exposure and age-related skin conditions such as actinic keratoses, xerosis cutis, neoplasms and inflammatory diseases were the most frequent dermatoses identified, although melanoma and/or non-melanoma skin cancer were the skin conditions investigated most frequently. Evidence regarding the burden of skin conditions included self-reported skin symptoms and concerns, mortality, burden on the health system, and impact on quality of life. A minority of articles reported effects of screening, risk assessment, diagnosis, prevention and treatment, mainly regarding skin cancer. A high number of skin conditions and diseases affect older people living at home and in the community but evidence about the burden and effective prevention and treatment strategies is weak. Best practices of how to improve dermatological care in older people remain to be determined and there is a particular need for interventional studies to support and to improve skin health at home.

Methods for Neuroscience Drug Development: Guidance on Standardization of the Process for Defining Clinical Outcome Strategies in Clinical Trials.

Neurosciences clinical trials continue to have notoriously high failure rates. Appropriate outcomes selection in early clinical trials is key to maximizing the likelihood of identifying new treatments in psychiatry and neurology. The field lacks good standards for designing outcome strategies, therefore The Outcomes Research Group was formed to develop and promote good practices in outcome selection. This article describes the first published guidance on the standardization of the process for clinical outcomes in neuroscience. A minimal step process is defined starting as early as possible, covering key activities for evidence generation in support of content validity, patient-centricity, validity requirements and considerations for regulatory acceptance. Feedback from expert members is provided, regarding the risks of shortening the process and examples supporting the recommended process are summarized. This methodology is now available to researchers in industry, academia or clinics aiming to implement consensus-based standard practices for clinical outcome selection, contributing to maximizing the efficiency of clinical research.

Effects of a leave-on product on the strength of the dermoepidermal junction: An exploratory, intraindividual, randomized controlled trial in older adults with dry skin.

Background and Aims: Skin aging is associated with dry skin and a decrease of the strength of the dermoepidermal adhesion, which increases the risk for lacerations (skin tears). Application of leave-on products improves dry skin and seems to reduce skin tear incidence. The aim of this study was to measure the effects of a humectant containing leave-on product on the strength of the dermoepidermal junction in older adult participants with dry skin. Methods: A randomized controlled trial using a split body design was conducted. One forearm was randomly selected and treated with a lipophilic leave-on product containing 5% urea for 8 weeks. The other forearm was the control. The parameters stratum corneum hydration (SCH), transepidermal water loss, pH, roughness, epidermal thickness and skin stiffness were measured at the baseline, Weeks 4 and 8. At Week 8, suction blisters were created and time to blistering was measured. Blister roofs and interstitial fluid were analyzed for Interleukin-1α, 6 and 8. Results: Twelve participants were included. After 8 weeks treatment, SCH was higher (median difference 11.6 AU), and the overall dry skin score (median difference -1) and median roughness (Rz difference -12.2 µm) were lower compared to the control arms. The median group difference for Interleukin-1α was -452 fg/µg total protein (TP) in the blister roofs and -2.2 fg/µg TP in the blister fluids. The median time to blister formation was 7.7 min higher compared to the control arms. Conclusion: The regular application of humectant containing leave-on products improves dry skin and seems to lower inflammation and contribute to the strengthening of the dermoepidermal adhesion. This partly explains how the use of topical leave-on products helps to prevent skin tears.

Technology for managing incontinence: What are the research priorities?

Incontinence and toileting difficulties can often be successfully addressed by treating their underlying causes. However, (complete) cure is not always possible and continence products to prevent or contain unresolved leakage or to facilitate toileting are in widespread use. Many people use them successfully but identifying the product(s) most likely to meet individual needs can be challenging and the recently published Seventh International Consultation on Incontinence includes a chapter which draws on the literature to provide evidence-based recommendations to help clinicians and product users to select appropriate products. This paper is based on the same evidence, but reviewed from the different perspective of those keen to identify unmet needs and develop improved products. For each of the main continence product categories it (i) outlines the design approach and key features of what is currently available; (ii) provides a generic functional design specification; (iii) reviews how well existing products meet the requirements of their main user groups; and (iv) suggests priorities for the attention of product designers. It also flags some core scientific problems which - if successfully addressed - would likely yield benefits in multiple incontinence product contexts.

Skin care types, frequencies and products: A cross-sectional study in German institutional long-term care.

AIM: The aim of the study was to describe types and frequencies of skin care interventions and products provided in institutional long-term care. MATERIALS AND METHODS: Baseline data from a cluster randomized controlled trial conducted in nursing homes in Berlin, Germany was collected before randomization. Numbers, proportions and frequencies of washing, showering and bathing, and the application of leave-on products were calculated. Product labels were iteratively and inductively categorized into overarching terms and concepts. RESULTS: A total of n = 314 residents participated in the study. In the majority, washing of the whole body was done once daily, and showering was performed once per week or more rarely. The majority received leave-on products daily on the face and once per week on the whole body. Most of the skin care interventions were delivered by nurses. There was marked heterogeneity in terms of product names, whereas the product names reveal little about the ingredients or composition. CONCLUSION: Personal hygiene and cleansing interventions are major parts of clinical practice in long-term care. Daily washing is a standard practice at the moment. In contrast, leave-on products are used infrequently. To what extent the provided care promotes skin integrity is unclear. Due to the heterogeneity and partly misleading labels of skin care products, informed decision making is difficult to implement at present. GOV IDENTIFIER: NCT03824886.

Protocol of a scoping review of outcome domains in dermatology.

INTRODUCTION: Core outcome sets (COSs) are agreed outcomes (domains (subdomains) and instruments) that should be measured as a minimum in clinical trials or practice in certain diseases or clinical fields. Worldwide, the number of COSs is increasing and there might be conceptual overlaps of domains (subdomains) and instruments within disciplines. The aim of this scoping review is to map and to classify all outcomes identified with COS projects relating to skin diseases. METHODS AND ANALYSIS: We will conduct a scoping review of outcomes of skin disease-related COS initiatives to identify all concepts and their definitions. We will search PubMed, Embase and Cochrane library. The search dates will be 1 January 2010 (the point at which Core Outcome Measures in Effectiveness Trials (COMET) was established) to 1 January 2024. We will also review the COMET database and C3 website to identify parts of COSs (domains and/or instruments) that are being developed and published. This review will be supplemented by querying relevant stakeholders from COS organisations, dermatology organisations and patient organisations for additional COSs that were developed. The resulting long lists of outcomes will then be mapped into conceptually similar concepts. ETHICS AND DISSEMINATION: This study was supported by departmental research funds from the Department of Dermatology at Northwestern University. An ethics committee review was waived since this protocol was done by staff researchers with no involvement of patient care. Conflicts of interests, if any, will be addressed by replacing participants with relevant conflicts or reassigning them. The results will be disseminated through publication in peer-reviewed journals, social media posts and promotion by COS organisations.

Using behavioral science to increase core outcome set use in trials.

OBJECTIVES: Core outcome sets (COS) are agreed sets of outcomes for use in clinical trials, which can increase standardization and reduce heterogeneity of outcomes in research. Using a COS, or not, is a behavior that can potentially be increased using behavioral strategies. The aim of this study was to identify behavioral intervention components to potentially increase use of COS in trials. METHODS: This project was informed by the Behavior Change Wheel framework. Two reviewers extracted barriers and facilitators to COS use from four recently published studies examining COS use in trials. Barriers and facilitators were coded to the Capability, Opportunity, Motivation-Behavior (COM-B) model, which forms part of the Behavior Change Wheel. COM-B findings were mapped to intervention functions by two reviewers, and then mapped to behavior change techniques (BCTs). Full-team Affordability, Practicability, Effectiveness/Cost-effectiveness, Acceptability, Side effects/Safety, Equity ratings were used to reach consensus on intervention functions and BCTs. BCTs were operationalized using examples of tangible potential applications and were categorized based on similarity. RESULTS: Barriers and facilitators were identified for all capability, opportunity and motivation aspects of the COM-B model. Five intervention functions (education, training, enablement, persuasion, and modeling) and 15 BCTs were identified. Thirty-six BCT examples were developed, including providing information on benefits of COS for health research, and information choosing COS. BCT examples are categorized by approaches related to "workshops," "guidance," "audio/visual resources," and "other resources." CONCLUSION: Study findings represent diverse ways to potentially increase COS use in trials. Future work is needed to examine effects of these behavioral intervention components on COS use. If effective, increased use of COS can improve outcome reporting and minimize outcome heterogeneity and research waste.

Protocol for the Development of the Fourth Edition of the Prevention and Treatment of Pressure Ulcers/Injuries: Clinical Practice Guideline Using GRADE Methods.

ABSTRACT: The National Pressure Injury Advisory Panel, European Pressure Ulcer Advisory Panel, and the Pan Pacific Pressure Injury Alliance are commencing a new (fourth) edition of the Prevention and Treatment of Pressure Ulcers/Injuries: Clinical Practice Guideline . The fourth edition of the International Pressure Injury (PI) Guideline will be developed using GRADE methods to ensure a rigorous process consistent with evolving international standards. Clinical questions will address prevention and treatment of PIs, identification of individuals at risk of PIs, assessment of skin and tissues, and PI assessment. Implementation considerations supporting application of the guidance in clinical practice will be developed. The guideline development process will be overseen by a guideline governance group and methodologist; the guideline development team will include health professionals, educators, researchers, individuals with or at risk of PIs, and informal carers.This article presents the project structure and processes to be used to undertake a systematic literature search, appraise risk of bias of the evidence, and aggregate research findings. The methods detail how certainty of evidence will be evaluated; presentation of relative benefits, risks, feasibility, acceptability, and resource requirements; and how recommendations will be made and graded. The methods outline transparent processes of development that combine scientific research with best clinical practice. Strong involvement from health professionals, educators, individuals with PIs, and informal carers will enhance the guideline's relevance and facilitate uptake. This update builds on previous editions to ensure consistency and comparability, with methodology changes improving the guideline's quality and clarity.