Search

Background There is substantial heterogeneity between trial outcomes in pressure ulcer prevention research. The development of core outcome sets is one strategy to improve comparability between trial results and thus increase the quality of evidence. Objectives To identify core outcomes for pressure ulcer prevention trials. Methods A workshop was held with service users to discuss their views and understanding of the outcomes identified by a scoping review and to identify any missing outcomes. In a next step, a Delphi survey comprising three rounds was conducted to evaluate a compiled list of outcomes by their importance. Afterwards the preselection from the Delphi survey was discussed in a virtual consensus meeting with the aim of agreeing on a final set of core outcomes. Individuals who had completed all three rounds of the Delphi survey were eligible to participate in this meeting. Participants included practitioners, service users, researchers and industry representatives. The OUTPUTs project is registered in the COMET database and is part of the Cochrane Skin Core Outcome Set Initiative. Results The workshop did not reveal any missing outcomes, but highlighted the need for further efforts to make lay people understand what an outcome is in a study setting. The Delphi survey took place between December 2020 and June 2021. After the three rounds, 18 out of 37 presented outcomes were rated to be critically important. In the following consensus meeting, six outcomes were prioritized to be included in the core outcome set for pressure ulcer prevention trials: (i) pressure ulcer occurrence; (ii) pressure ulcer precursor signs and symptoms; (iii) mobility; (iv) acceptability and comfort of intervention; (v) adherence/compliance; and (vi) adverse events/safety. Conclusions Based on a comprehensive list of outcomes in pressure ulcer prevention research, there was clear agreement on the six identified core outcomes in three international Delphi rounds and in the consensus meeting. Although outcome measurement instruments need to be identified next, the six identified core outcomes should already be considered in future trials, as service users, practitioners, researchers and industry representatives have agreed that they are critically important. What is already known about this topic? There are numerous trials on pressure ulcer prevention, but evidence on the effectiveness of preventive measures is limited due to heterogeneity between trial outcomes.The development of a core outcome set is one strategy to improve comparability between trial results. What does this study add? A service user workshop, a three-round Delphi survey and an online consensus meeting with practitioners, service users, researchers and industry representatives were conducted to identify core outcomes for pressure ulcer prevention trials.Six core outcomes were defined: (i) pressure ulcer occurrence, (ii) pressure ulcer precursor signs and symptoms, (iii) mobility, (iv) acceptability and comfort of intervention, (v) adherence/compliance and (vi) adverse events/safety. What are the clinical implications of this work? Better evidence of interventions for pressure ulcer prevention will help health professionals and service users to decide which interventions are most appropriate and effective.Better evidence may contribute to better pressure ulcer prevention.

Background Epidermolysis bullosa (EB) is a rare, genetically and clinically heterogeneous group of skin fragility disorders. No cure is currently available, but many novel and repurposed treatments are upcoming. For adequate evaluation and comparison of clinical studies in EB, well-defined and consistent consensus-endorsed outcomes and outcome measurement instruments are necessary. Objectives To identify previously reported outcomes in EB clinical research, group these outcomes by outcome domains and areas and summarize respective outcome measurement instruments. Methods A systematic literature search was performed in the databases MEDLINE, Embase, Scopus, Cochrane CENTRAL, CINAHL, PsycINFO and trial registries covering the period between January 1991 and September 2021. Studies were included if they evaluated a treatment in a minimum of three patients with EB. Two reviewers independently performed the study selection and data extraction. All identified outcomes and their respective instruments were mapped onto overarching outcome domains. The outcome domains were stratified according to subgroups of EB type, age group, intervention, decade and phase of clinical trial. Results The included studies (n = 207) covered a range of study designs and geographical settings. A total of 1280 outcomes were extracted verbatim and inductively mapped onto 80 outcome domains and 14 outcome areas. We found a steady increase in the number of published clinical trials and outcomes reported over the past 30 years. The included studies mainly focused on recessive dystrophic EB (43%). Wound healing was reported most frequently across all studies and referred to as a primary outcome in 31% of trials. Great heterogeneity of reported outcomes was observed within all stratified subgroups. Moreover, a diverse range of outcome measurement instruments (n = 200) was identified. Conclusions We show substantial heterogeneity in reported outcomes and outcome measurement instruments in EB clinical research over the past 30 years. This review is the first step towards harmonization of outcomes in EB, which is necessary to expedite the clinical translation of novel treatments for patients with EB.

Objective: After launching the 2019 International Pressure Ulcer/Injury Guideline, the National Pressure Injury Advisory Panel (NPIAP), the European Pressure Ulcer Advisory Panel (EPUAP) and the Pan Pacific Pressure Injury Alliance (PPPIA) collaborated with Sensorydata Corp., US, to develop a guideline app (InterPIP App). The app was designed to: present evidence-based guideline recommendations; incorporate search capacities and functionality to facilitate easy access to clinical guidance; provide accessibility in multiple languages; and to be available worldwide at a reasonable price, including opportunities for free access in low-resource countries. This paper describes the development, dissemination and formative evaluation of a mobile app providing evidence-based recommendations for pressure injury prevention, assessment/classification, and treatment at the point of care. Method: An evaluation tool was designed based on a framework developed by Nouri et al. and made available to all app subscribers. Results: The InterPIP App is currently available in 11 languages and had been downloaded 3616 times by February 2022 in 78 countries. A total of 62 individuals responded to the survey of end-users. In this formal evaluation of user experiences, the app was rated positively on criteria of: information/content; usability; design; functionality; ethics; and security/privacy (median=4 on a 1–5 Likert scale). Overall perceived value was ranked lower with a median of three. Users provided suggestions for ongoing app enhancement. Conclusion: The InterPIP App offers a unique opportunity to bring evidence-based guidance to the point of care. Formal evaluation of end-user experiences identified opportunities for quality improvement, and informed plans for future development and evaluation.

The International Wound Dressing Technology Expert Panel has provided important work about the history of wound treatment dressing construction, development and testing methods related to clinical performance. As it now stands, these types of dressings require additional rigorous engineering testing to ensure that the indication of a dressing, whether for treatment or prevention of wounds such as pressure injuries, achieve their mechanical claims and targets clinical efficacy. The National Pressure Injury Advisory Panel (NPIAP) and European Pressure Ulcer Advisory Panel (EPUAP) have established the first such standards initiative in prophylactic dressings to deploy unbiased methods for establishing manufacturing standards in the pressure injury market. We hope that as readers digest the information from this international panel, they consider the future opportunities of working with NPIAP and EPUAP to further advance market access for appropriately manufactured wound dressings.

Background. Pregnancy leads to several skin changes, but evidence about structural and functional skin changes is scarce. Findings on skin structure and function in children in their first year reveal rapid skin maturation, but evidence indicates that in particular, water holding and transport mechanisms are different from adults. Important questions include whether maternal cutaneous properties predict infant skin condition, and if so, how. This is especially relevant for the skin’s microbiome because it closely interacts with the host and is assumed to play a role in many skin diseases. Therefore, the study objective is to explore characteristics of skin and hair of pregnant women and their newborns during pregnancy and in the first six months after delivery and their associations. Methods. The study has an observational longitudinal design. We are recruiting pregnant females between 18 and 45 years using advertisement campaigns in waiting areas of gynecologists and hospital’s outpatient services. A final sample size of n = 100 women is the target. We perform noninvasive, standardized skin, hair, and skin microbiome measurements. We establish the baseline visit during pregnancy until at the latest four weeks before delivery. We schedule follow-up visits four weeks and six months after birth for mothers and their newborns. We will calculate descriptive statistical methods using frequencies and associations over time depending on scale levels of the measurements. Discussion. The majority of previous studies that have investigated infants’ skin microbiome and its associations used cross-sectional designs and focused on selected characteristics in small samples. In our longitudinal study, we will characterize a broad range of individual and environmental characteristics of mothers and their newborns to evaluate interrelationships with skin parameters and their changes over time. Considering the combination of these multiple variables and levels will allow for a deeper understanding of the complex interrelationship of the newborn’s skin maturation. This trial is registered with ClinicalTrials.gov (Identifier: NCT04759924).

Background: Medium, large and giant congenital melanocytic naevi (CMN) can impose a psychosocial burden on patients and families, and are associated with increased risk of developing melanoma or neurological symptoms. Lack of consensus on what outcomes to measure makes it difficult to advise patients and families about treatment and to set up best practice for CMN. Objectives: Fostering consensus among patient representatives and professionals, we aim to develop a core outcome set, defined as the minimum set of outcomes to measure and report in care and all clinical trials of a specific health condition. We focused on the ‘what to measure’ aspect, the so-called core domain set (CDS), following the COMET and CS-COUSIN guidelines. Methods: We conducted a systematic review to identify outcomes reported in the literature. Focus groups with patient representatives identified patient-reported outcomes. All these outcomes were classified into domains. Through e-Delphi surveys, 144 stakeholders from 27 countries iteratively rated the importance of domains and outcomes. An online consensus meeting attended by seven patient representatives and seven professionals finalized the CDS. Results: We reached consensus on six domains, four of which were applied to both care and research: ‘quality of life’, ‘neoplasms’, ‘nervous system’ and ‘anatomy of skin’. ‘Adverse events’ was specific to care and ‘pathology’ to research. Conclusions: We have developed a CDS for medium-to-giant CMN. Its application in reporting care and research of CMN will facilitate treatment comparisons. The next step will be to reach consensus on the specific outcomes for each of the domains and what instruments should be used to measure these domains and outcomes.

Alopecia areata (AA) is an autoimmune-mediated non-scarring hair loss whose stigmatizing effect may have severe psychosocial impact. AA has been reported to be correlated with bullying, reduced quality of life (QoL) and psychiatric comorbidities. The effect of AA on QoL in adult patients has been systematically reviewed and found to be detrimental. No systematic evaluation of QoL in children with AA has been performed. The aim of this review is to systematically describe QoL in the child and adolescent population affected by AA. A systematic review in multiple databases and grey literature sources was conducted. Search terms included, but were not limited to, alopecia areata and quality of life. Only studies reporting results on health-related QoL in children and adolescents were included. We evaluated the studies regarding risk of bias, and conceptual rigor concerning quality of life and performed a descriptive synthesis of findings. Eight studies met the inclusion criteria, encompassing 358 participants with AA and 64 healthy peers. Seven studies were quantitative using four different standardized questionnaires and scores to measure QoL. One study used a qualitative design. All studies described an impairment of children and adolescents' QoL by AA. The most consistently affected QoL domain was embarrassment and self-consciousness. Further psychosocial implications of AA included bullying and limiting participation in school or spare time activities. Existing evidence indicates a substantial impact of AA on QoL in children. In daily clinical practice as well as for developing new treatments QoL in pediatric AA plays a critical role. It should be considered as a key outcome in clinical research and decision-making.

Linked Article: Langbroek et al. Br J Dermatol 2022; 187:730–742.

Wund-D.A.CH., as the umbrella organization of German-speaking wound treatment societies, has currently developed a best practice recommendation for skin damage caused by body fluids, which is known as moisture-associated skin damage (MASD) in English-speaking countries. In this expert consensus, the diseases incontinence-associated dermatitis (IAD), intertriginous dermatitis, including intertrigo, gram-negative bacterial toe web infection and toxic contact dermatitis, including periwound and peristomal dermatitis are presented in a differentiated manner. A common feature of these clinical diseases is a deterioration of skin integrity due to prolonged exposure to body fluids such as urine, stool, sweat or wound exudate with associated physical-irritative and/or chemical irritation. In addition, other comorbidities and cofactors play an important role. The diagnosis of these interdisciplinary and interprofessionally relevant MASD is difficult in everyday clinical practice because there are currently no uniform definitions and many relevant differential diagnoses. Effective strategies for the prevention and therapy of these skin diseases are, for example, continence management, use of efficient, absorbent aids with good retention as well as consistent skin protection and adequate skin care. Another important aspect is the education of patients and relatives about the origin, treatment and prevention of MASD.

IntroductionAgeing is accompanied by an age-related decrease in mobility or cognitive and sensory functions; in addition, physiological changes in the skin occur with age. Therefore, the skin requires appropriate care and observation in order to prevent or manage a variety of dermatological diseases and conditions, and to prevent or minimise effects on the quality of life.Globally, most older people live at home, and the need to establish sustainable structures and processes to support and to care for people at home for as long as possible has been emphasised. The body of evidence supporting screening, diagnosis and management of skin conditions in older people living at home has not been collated and summarised to date. The aim of this scoping review is to describe and summarise the extent and nature of the available body of evidence in this regard.Methods and analysisThis scoping review will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews. Eligibility criteria were developed using the Population, Concept and Context framework, and the search will focus on systematic and scoping reviews as well as clinical practice guidelines. Two reviewers will conduct systematic searches, screen and select identified evidence as well as extract and chart data, independently. Finally, data will be systematically analysed and summarised descriptively to map existing evidence and identify gaps.Ethics and disseminationDue to the nature of research, not involving humans or unpublished secondary data, approval of an ethics committee is not required. The dissemination of findings is planned via professional networks and publication in scientific open access journals.

Aim To describe the skin areas most often affected by intertrigo, the clinical severity and duration of intertrigo and possible risk factors. Materials and methods Secondary analysis of data from 2013 to 2016 collected by the International Prevalence Measurement of Care Quality in Dutch hospitals, care homes and community care. Results In total, n = 7,865 (mean age 80.1 years) subjects were included in this analysis. The inguinal, breast and gluteal cleft skin areas were most often affected by intertrigo. The skin was often inflamed but not eroded. Strongest associations between intertrigo at inguinal skin and diabetes mellitus (OR 1.8; 95% CI 1.1 - 3.1), intertrigo at sub mammary folds and urinary incontinence (OR 1.6; 95% CI 0.9-2.9) and between intertrigo at gluteal cleft and urinary incontinence (OR 2.9; 95% CI 1.4 – 5.2) were observed. Conclusion The inguinal region, sub mammary folds and gluteal clefts are most often affected by intertrigo. Female sex, urinary incontinence and high BMI seem to enhance intertrigo risk at all of these skin areas.

Evidence suggests that preventive dressings applied on sacral skin help to prevent pressure ulcers. However, possible performance differences of different dressing types are unclear. An exploratory randomized crossover trial with intra-individual comparisons was conducted to compare the effects of three different multi-layer foam dressings (Mepilex Border Sacrum, ALLEVYN Life Sacrum and Optifoam Gentle Sacrum) compared to no dressing on the sacral skin. Healthy female volunteers (n = 12, mean age 72 years) wore three different dressings on their sacral skin for 3.5 hours while lying supine on a standard hospital mattress. At regular intervals, subjects performed standardized movements to enhance shear loads. Skin surface temperature, stratum corneum hydration, erythema, skin roughness and the interleukin 1 alpha (IL-1 alpha) concentration per total protein were measured at baseline and after the lying periods. After 3.5 hours, the median skin temperature increased in all four groups between 3.0 degrees C and 3.8 degrees C with only minor differences between the no dressing and the dressing groups. Median stratum corneum hydration increased during the lying period in all groups with highest increases in the Optifoam Gentle Sacrum (7.3 arbitrary units) and no dressing group (7.0 arbitrary units). There was a median decrease of the mean roughness (Rz) in the Optifoam Gentle Sacrum group of -6.3 mu m but no relevant changes in the other groups. After loading, the erythema index was highest in the ALLEVYN Life Sacrum and no dressing groups. Highest releases of IL-1 alpha were observed in the ALLEVYN Life Sacrum and Optifoam Gentle Sacrum groups, in the Mepilex Border Sacrum group changes were minor. Study results indicate, that the application of preventive dressings on sacral skin during loading do not cause additional occlusion compared to loading without dressings when lying supine. Different dressings cause different cutaneous responses during loading.

Justification of nurses' interventions for skin cleansing and skincare: Qualitative results of the SKINCARE-Pilot study

Zusammenfassung. Hintergrund: Die Unterstützung bei der Körperpflege gehört zu den Kernaufgaben der Pflege. Verschiedene Faktoren können die Umsetzung evidenzbasierter Pflege beeinflussen. Ziel: Die Untersuchung von Sichtweisen beruflich Pflegender in der stationären Langzeitpflege zur Bedeutung und zur Begründung pflegerischer Maßnahmen in der Unterstützung der Körperpflege. Methode: Qualitativer Teil einer Mixed-Methods-Studie in drei Langzeitpflegeeinrichtungen, bestehend aus Kurzinterviews mit beruflich Pflegenden direkt nach der Durchführung der pflegerischen Unterstützung bei der Körperpflege, Fokusgruppen mit Pflegenden und semistrukturierte Interviews mit Pflegemanagement-Verantwortlichen. Die Daten wurden inhaltsanalytisch ausgewertet. Ergebnisse: Die Stichprobe ( N = 30) umfasst 10 Kurzinterviews, 3 Fokusgruppen ( n = 17) und 3 Einzelinterviews. Pflegende wiesen der pflegerischen Unterstützung in der Körperpflege überwiegend eine hohe Relevanz zu. Als Grundlage für pflegerische Entscheidungen wurden Bewohnerbedürfnisse und -präferenzen, persönliches Wissen sowie eigene Erfahrungen und Präferenzen genannt. Evidenzbasierte Wissensquellen wurden kaum erwähnt. Als beeinflussende Faktoren wurden die Verfügbarkeit von Hautreinigungs- und Hautpflegeprodukten, personelle und zeitliche Ressourcen sowie die pflegerisch-ärztliche Zusammenarbeit identifiziert. Schlussfolgerungen: Pflegerische Entscheidungen in der Unterstützung der Körperpflege berücksichtigen kaum forschungsgestützte Evidenz. Evidenzbasierte Entscheidungshilfen könnten die Auswahl geeigneter Pflegeinterventionen für Pflegende erleichtern.

Um die Wirksamkeit von praventiven Auflagen zur Dekubitusprophylaxe beurteilen zu konnen, wurden uber eine Literaturrecherche in den Datenbanken PubMed und CINAHL drei systematische Ubersichtsarbeiten und zusatzlich eine randomisierte kontrollierte Studie eingeschlossen. Neun der 13 betrachteten Einzelstudien kommen zu dem Ergebnis, dass praventive Auflagen eine wirksame Masnahme zur Dekubitusprophylaxe darstellen. Aufgrund von methodischen Mangeln in den Studien, die teilweise schwer uberwunden werden konnen, aber auch aufgrund ihrer Heterogenitat, ist die Aussagekraft eingeschrankt. Unabhangig von der Verwendung von praventiven Auflagen in der Praxis sollen etablierte Masnahmen, wie die Mobilisation und/oder Positionswechsel weiterhin durchgefuhrt werden.

Background The non-invasive skin barrier measurements transepidermal water loss, stratum corneum hydration and the skin surface pH are widely used in clinical skin research. Relative and absolute measurement errors of these measurements are unknown in geriatric care settings. Material and methods Transepidermal water loss, stratum corneum hydration, skin surface pH and temperature were measured on the volar forearm and lower leg twice by trained raters within a cross-sectional study in ten nursing homes. Intrarater reliability was calculated using the ICC (1,1). Intrarater agreement was analyzed using Bland Altman Plots with limits of agreement. Results Two hundred twenty-three residents were included and mean age was 84.2 years. The highest ICC was found for transepidermal water loss and skin surface temperature of the leg with 0.95 (95% CI 0.93 to 0.96). The ICC of the stratum corneum was 0.91 (95% CI 0.88 to 0.93) for both investigated skin areas. The measurement of the pH at the lower leg had the lowest ICC with 0.73 (95% CI 0.66 to 0.78). Highest limits of agreement of approximately 8 a.u. were calculated for stratum corneum hydration and lowest limits of agreement of approximately 1 °C were calculated for skin surface pH. Conclusion Relative measurement errors of transepidermal water loss and stratum corneum hydration were very low indicating that single measurements provide reliable estimates in this population and setting. However, the absolute measurement errors were high for both of these parameters. To increase reliability of skin surface pH we recommend at least two repeated measurements.

Background: Standardized outcome reporting is crucial for trial evidence synthesis and translation of findings into clinical decision making. The OMERACT 2.0 Filter and COMET outcome domain taxonomy propose frameworks for consistent reporting of outcomes. There is an absence of a uniform dermatology-specific reporting strategy that uses precise and consistent outcome definitions. Objectives: Our aim was to map efficacy/effectiveness outcomes assessed in dermatological trials to the OMERACT 2.0 Filter as a starting point for developing an outcome taxonomy in dermatology. Methods: We critically appraised 10 Cochrane Skin Reviews randomly selected from all 69 Cochrane Skin Reviews published until 01/2015 and the 220 trials included covering a broad spectrum of dermatological conditions and interventions. Efficacy/effectiveness outcomes were mapped to core areas and domains according to the OMERACT 2.0 Filter. The extracted trial outcomes were used for critical appraisal of outcome reporting in dermatology trials and for the preliminary development of a dermatology-specific outcome taxonomy. Results: The allocation of 1,086 extracted efficacy/effectiveness outcomes to the OMERACT 2.0 Filter resulted in a hierarchically structured dermatology-specific outcome classification. In 506 outcomes (47%) the outcome concept to be measured was insufficiently described, hindering meaningful evidence synthesis. Although the core areas assessed in different dermatology trials of the same condition overlap considerably, quantitative evidence synthesis usually failed due to imprecise outcome definitions, non-comparable outcome measurement instruments, metrics and reporting. Conclusions: We present an efficacy/effectiveness outcome classification as a starting point for a dermatology-specific taxonomy to provide trialists and reviewers with the opportunity to better synthesize and compare evidence.

Introduction Gender and/or sex have a major impact on staying healthy, becoming ill, or care dependent. Differences between men and women have been described for socioeconomic positions, health behaviors, courses and severities of diseases and mortality rates. Consequently, sex and/or gender need to be adequately taken into account while developing and implementing evidence-based healthcare. Evidence regarding differences between men and women in pressure ulcer care is limited. Our research aim was to measure possible differences between male and female hospital patients and nursing home residents in prevention and treatment of institutional-acquired pressure ulcers. Methods A secondary data analysis was conducted including data sets collected in nursing homes and hospitals in Germany annually from 2001 to 2016. Relevant variables were compared according to biological sex (men/woman). Results The study included 38,655 nursing home residents (mean age 85.4 years women, 77.3 years men) and 58,760 hospital patients (mean age 66.7 years women, 63.4 years men). More women were underweight and at pressure ulcer risk in both settings. The proportion of institutional-acquired pressure ulcers was higher for men in hospitals. Slightly more men had a PU category 2 to 4 (OR 0.87, 95% CI 0.76 to 0.99) in nursing homes or developed an institutional-acquired pressure ulcers category 2 to 4 in both settings (OR 0.85, 95% CI 0.76 to 0.95). Special mattresses were more often used by women at PU risk. More men with an institutional-acquired pressure ulcer in hospitals received counseling of relatives (OR 0.53, 95% CI 0.39 to 0.72). Conclusion Although slightly more men had institutional-acquired pressure ulcers than women, overall differences regarding pressure ulcer occurrence were minor. Gender and/or sex can rather not be considered as an independent risk factor for pressure ulcer development and differences regarding pressure ulcer prevention interventions seem to be minor.

Pressure ulcer incidence is high in intensive care units. This causes a serious financial burden to healthcare systems. We evaluated the cost-effectiveness of multi-layered silicone foam dressings for prevention of sacral and heel pressure ulcers in addition to standard prevention in high-risk intensive care units patients. A randomised controlled trial to assess the efficacy of multi-layered silicone foam dressings to prevent the development of pressure ulcers on heels and sacrum among 422 intensive care unit patients was conducted. Direct costs for preventive dressings in the intervention group and costs for treatment of incident pressure ulcers in both groups were measured using a bottom-up approach. A cost-effectiveness analysis by calculating the incremental cost-effectiveness ratio using different assumptions was performed. Additional dressing and labour costs of ���150.81 (���116.45 heels; ���34.36 sacrum) per patient occurred in the intervention group. Treatment costs were ���569.49 in the control group and ���134.88 in the intervention group. The incremental cost-effectiveness ratio was ���1945.30 per PU avoided (���8144.72 on heels; ���701.54 sacrum) in the intervention group. We conclude that application of preventive dressings is cost-effective for the sacral area, but only marginal on heels for critically ill patients.

Today, patients with chronic wounds are treated in many different fields of medicine. Despite this great interdisciplinary and interprofessional importance, there is still a lack of uniformly accepted definitions and classifications. Therefore, a group of experts from the professional society Initiative Chronische Wunden (ICW) e. V. translated and adapted the classification of chronic wounds into healable, maintenance and nonhealable wounds on the basis of the internationally published literature into German. This classification results in the aim of curative, limited respectively non-curative or palliative wound care, which are very important for everyday clinical practice. It thus becomes clear that complete wound closure is not always the central intention of wound treatment. For many patients with chronic wounds, other aspects such as the best possible quality of life and the promotion of health-related self-management as well as the avoidance of complications are important for treatment concepts. These therapy intentions should be differentiated and individually discussed with patients in order to facilitate shared decision making.Patienten mit chronischen Wunden werden heute in vielen unterschiedlichen Bereichen der Medizin behandelt. Trotz dieser großen interdisziplinären und interprofessionellen Bedeutung, fehlt es weiterhin an einheitlich akzeptierten Definitionen und Einteilungen. Eine Expertengruppe der Fachgesellschaft Initiative Chronische Wunden (ICW) e. V. hat daher auf der Basis international publizierter Literatur eine Einteilung chronischer Wunden in heilende, schwer heilende und nicht heilbare Wunden vorgenommen. Hieraus ergeben sich für den klinischen Alltag sehr wichtigen übergeordneten Ziele einer kurativen, bedingt bzw. nicht kurativen oder palliativen Wundversorgung. Es wird somit deutlich, dass der vollständige Wundverschluss nicht immer das zentral wichtige Ziel der Wundbehandlung ist. Bei vielen Patienten mit chronischen Wunden stehen daher andere Aspekte wie beispielsweise die bestmögliche Lebensqualität und die Förderung des gesundheitsbezogenen Selbstmanagements sowie die Vermeidung von Komplikationen im Vordergrund der Behandlungskonzepte. Diese Therapieziele sollten möglichst frühzeitig gemeinsam mit den Patienten differenziert und individuell festgelegt werden.

Background Consumer engagement is a requirement of high quality clinical guidelines. Developing strategies to engage consumers and incorporate the perspectives of individuals with or at risk of pressure ulcers/injuries and their informal caregivers was one priority in the recent update of the EPUAP/NPIAP/PPPIA's Prevention and Treatment of Pressure Ulcers/Injuries: Clinical Practice Guideline. Aims The aims were to determine the goals of individuals and caregivers for pressure ulcer/injury care, priorities for pressure ulcer/injury education and biggest problems related to pressure ulcers/injuries. Methods An online, anonymous, international 10-item survey, accessible in nine languages was provided to individuals and their caregivers from April to October 2018. Descriptive statistics were used for quantitative data and a thematic analysis approach was used to analyse qualitative data. Results There were 1233 individuals from 27 countries who completed the survey. Overall, individuals and caregivers had similar goals of care. Reducing the size of pressure ulcer/injury was selected more often as a care goal than complete healing. Individuals, compared to caregivers, considered managing pain more important. Qualitative data analysis identified five themes including knowledge, attitudes, and skills; risk factors for pressure ulcer/injury; accessing pressure ulcer/injury care; quality of life for patients and caregivers; and the pressure ulcer/injury. Conclusions The consumer survey provided consumer engagement and perspective that was incorporated into guideline development, including consideration during evaluation of the relevance and acceptability of recommendations, and assignment of recommendation strength ratings.

Background There is a high incidence of pressure ulcers in high-risk settings such as intensive care. There is emerging evidence that the application of dressings to pressure ulcer predilection areas (sacrum and heels) improves prevention strategies. Objectives To determine whether preventive dressings, applied to the sacrum and heels of high-risk patients in intensive care units, in addition to standard prevention, reduces the incidence of pressure ulcers. Methods Between June 2015 and July 2018, a randomized, controlled, two-arm, superiority pragmatic study was performed with a concealed 1 : 1 allocation to the intervention and control group. Patients assigned to the intervention group had dressings applied to the sacrum and heels. Results In total, 7575 patients were screened for eligibility and 475 patients were included and allocated to both groups. Finally, 212 patients in the intervention group and 210 in the control group were analysed. The mean age was 63 center dot 5 years and the majority of patients were male (65 center dot 4%). The cumulative pressure ulcer incidence category II and above was 2 center dot 8% in the intervention, and 10 center dot 5% in the control group (P = 0 center dot 001). Compared with the control group, the relative risk in the intervention group was 0 center dot 26 [95% confidence interval (CI) 0 center dot 11-0 center dot 62] and the absolute risk reduction was 0 center dot 08 (95% CI 0 center dot 03-0 center dot 13). Conclusions The results indicate that the application of dressings, in addition to standard prevention, in high-risk intensive care unit patients is effective in preventing pressure ulcers at the heels and sacrum. What's already known about this topic? Pressure ulcers are severe soft tissue injuries and wounds, which occur worldwide in all healthcare settings. Despite preventive interventions, pressure ulcers still develop. There is emerging evidence that dressings help to prevent pressure ulcers. What does this study add? The incidence of pressure ulcers in intensive care units among high-risk patients remains high. The application of dressings to the sacrum and heels, in addition to standard preventive measures, reduces the relative and absolute risks for the development of pressure ulcers. The application of preventive dressings at the heels and sacrum seems to be feasible in intensive care settings.

Mechanical loading causes skin occlusion and deformation, which influences structural and functional skin properties. Aims of the study were to measure structural and functional skin parameters after loading at the sacral and heel skin and to describe possible associations.A secondary data analysis based on a clinical trial with n = 15 aged women was conducted. Changes of transepidermal water loss, stratum corneum hydration, epidermal hydration, erythema, temperature, structural stiffness, elastic recovery, elastic function, and mean roughness after 120 min loading were described and compared. Spearman's rho (rLoading caused an increase of transepidermal water loss, stratum corneum and epidermal hydration, erythema and temperature at sacral and heel skin. There was a decrease of median roughness at the heel skin surface (-8.5 (IQR -10.5 to 5.5) μm). Strongest positive associations were observed between changes of elastic function and elastic recovery (rTwo hours loading on a standard foam mattress leads to skin occlusion at the skin surface and mechanical deformation. Skin occlusion seems primarily to increase temperature, stratum corneum and epidermal hydration that may affect mechanical skin properties. Mechanical deformation seems to be responsible for the erythematous response of the dermal skin layer.

IntroductionThe majority of aged long-term care receivers and patients in geriatric acute care are affected by some form of incontinence. These individuals are at risk of developing incontinence-associated dermatitis (IAD), a common type of irritant contact dermatitis caused by repeated and prolonged direct contact of the skin with urine and stool. The prevalence of IAD in these settings is high. Preventive measures include mild skin cleansing and the application of skin protecting leave-on products. Available evidence is weak regarding the comparative performance of different skin protection strategies and products due to a lack of confirmatory trials using relevant comparators and endpoints. Therefore, the overall aim of this exploratory trial is to compare the effects of three skin protection strategies to estimate effect sizes of the recently published core outcomes in IAD research.Methods and analysisA pragmatic three-arm, assessor-blinded, randomised controlled, exploratory trial with parallel group design will be performed, comparing film-forming and lipophilic skin protecting leave-on products for IAD prevention with standard incontinence care alone. The trial will be conducted in geriatric nursing homes and geriatric acute care settings in the federal state of Berlin, Germany. A total of n=210 participants being incontinent of urine and stool will be included. Outcomes include IAD incidence, erythema, erosion, maceration, IAD-related pain, patient satisfaction, safety, feasibility and compliance. IAD incidence of the control and intervention groups will be compared to estimate effect sizes, and the procedural feasibility of the intervention will be tested to plan a possible subsequent confirmatory randomised controlled trial.Ethics and disseminationThe study received the approval of the ethics committee of Charité–Universitätsmedizin Berlin (EA4/043/22). Results will be disseminated through peer-reviewed open-access journals and international conferences.Trial registration numberClinicalTrials.gov (NCT05403762) and German Clinical Trials Register (Deutsches Register Klinischer Studien, or DRKS) (DRKS00028954).