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.

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.

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.

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.

Core outcome domains for lichen sclerosus: a CORALS initiative consensus statement.

BACKGROUND: Lichen sclerosus (LS) is a chronic inflammatory condition mainly affecting genital skin. It causes distressing symptoms that impact daily quality of life (QoL). It causes progressive anatomical changes and a potential risk of cancer. Published randomized controlled trials are of varying methodological quality and difficult to combine in meta-analyses. This is partly due to lack of agreed outcome measures to assess treatment response. Identification of core outcome sets (COSs), which standardize key outcomes to be measured in all future trials, is a solution to this problem. OBJECTIVES: To obtain international agreement on which outcome domains should be measured in interventional trials of genital LS. METHODS: Recommended best practice for COS domain development was followed: (i) identification of potential outcome domains: a long list was generated through an up-to-date LS literature search, including information collected during the LS priority-setting partnership; (ii) provisional agreement of outcome domains: a three-stage multi-stakeholder international electronic-Delphi (e-Delphi) consensus study; (iii) final agreement of outcome domains: online consensus meeting with international stakeholders including anonymized voting. RESULTS: In total, 123 participants (77 patients, 44 health professionals, 2 researchers) from 20 countries completed three rounds of the e-Delphi study. Eleven outcome domains were rated as 'critical' and were discussed at the online consensus meetings. The first set of consensus meetings involved 42 participants from 12 countries. Consensus was met for 'symptoms' (100% agreed) and 'QoL - LS-specific' (92% agreed). After the second set of meetings, involving 29 participants from 12 countries, 'clinical (visible) signs' also met consensus (97% agreed). CONCLUSIONS: The international community has agreed on three key outcome domains to measure in all future LS clinical trials. We recommend that trialists and systematic reviewers incorporate these domains into study protocols with immediate effect. CORALS will now work with stakeholders to select an outcome measurement instrument per prioritized core domain.

Heterogeneity of reported outcomes in epidermolysis bullosa clinical research: a scoping review as a first step towards outcome harmonization.

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.

Quality of life in children and adolescents with alopecia areata-A systematic review.

Alopecia areata (AA) is an autoimmune-mediated non-scarring hair loss whose stigmatizing effect may have a 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 of 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 the risk of bias, and conceptual rigour concerning the 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 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 paediatric AA plays a critical role. It should be considered a key outcome in clinical research and decision-making.

Skin Care in Neonates and Infants: A Scoping Review.

BACKGROUND: Skin care is a basic, daily activity performed by formal and informal caregivers from birth until end of life. Skin care activities are influenced by different factors, e.g., culture, knowledge, industrial developments and marketing activities. Therefore, various preferences, traditions, and behaviors exist worldwide including skin care of neonates and infants. The objective of this scoping review was to obtain an overview about the evidence of skin care activities in neonates and infants. Studies from 2010 were eligible if the population was (skin) healthy neonates and infants; if the concept was skin care interventions; and if the context was at home, in a community setting, in a pediatric outpatient service, or in a hospital. We searched for the literature via OVID in MEDLINE and Embase, in the Cochrane Library, in trial registries and for gray literature. SUMMARY: We identified 42 studies since 2010, which examined four main skin care interventions: bathing, wiping, washing, and topical application of leave-on products. Details of interventions were often not reported, and if they were, they were not comparable. The four skin care interventions focused on 13 different care goals, mainly prevention of skin diseases, maintaining skin barrier function, and improving (skin) health. We evaluated effects of skin care interventions using 57 different outcome domains; 39 of 57 were skin-related and 18 were not. Mostly, laboratory or instrumental measurements were used. KEY MESSAGES: Our scoping review identified four skin care interventions with a broad heterogeneity of product categories and application details. Studies in skin care interventions should include all relevant information about product category and application details to ensure comparability of study results. This would be helpful in developing recommendations for formal and informal caregivers. We identified 13 skin care goals. "Maintaining healthy skin/skin barrier function/skin barrier integrity," "prevention of atopic dermatitis," "cleansing," and "improving skin barrier function" were most often allocated to skin care interventions. There is substantial variability regarding outcome domains in skin care research. Our results support the need of developing core outcome sets in the field of skin care in healthy skin, especially in this age-group of neonates and infants.

The theory and practice of pressure ulcer/injury risk assessment: a critical discussion.

Pressure ulcer/injury (PU) risk assessment is widely considered an essential component in clinical practice. It is a complex and broad concept that includes different approaches, such as clinical judgement, using standardised risk assessment instruments, skin assessments, or using devices to measure skin or tissue properties. A distinction between PU risk assessment and early detection is important. PU risk measures the individual's susceptibility to developing a PU under a specific exposure (primary prevention), and early detection includes the assessment of early (sub)clinical signs and symptoms to prevent progression and to support healing (secondary prevention). PU risk is measured using prognostic/risk factors or prognostic models. Every risk estimate is a probability statement containing varying degrees of uncertainty. It therefore follows that every clinical decision based on risk estimates also contains uncertainty. PU risk assessment and prevention is a complex intervention, where delivery contains several interacting components. There is a huge body of evidence indicating that risk assessment and its outcomes, the selection of preventive interventions and PU incidence are not well connected. Methods for prognostic model development and testing in PU risk research must be improved and follow state-of-the-art methodological standards. Despite these challenges, we do have substantial knowledge about PU risk factors that helps us to make better clinical decisions. An important next step in the development of PU risk prediction might be the combination of clinical and other predictors for more individualised care. Any prognostic test or procedure must lead to better prevention at an acceptable cost.

The prevalence and severity of dry skin and related skin care in older adult residents in institutional long-term care: A cross-sectional study.

OBJECTIVES: To identify possible factors associated with different severities of xerosis cutis and to describe possible associations between (skin) care dependency and application of moisturizers. DESIGN: Cross-sectional study using baseline data from a cluster-randomized controlled trial. Demographic and health characteristics, skin physiological measurements, functional abilities and application of moisturizers were compared between the participants with mild and severe dry skin. Frequency of moisturization were also compared based on the participants' skin care dependency. RESULTS: The more distal the body area, the more severe xerosis were observed. There were no or minor differences between the groups, except for the stratum corneum hydration and skin surface pH. Participants with severe xerosis received moisturizers less often. Skin care dependent residents received moisturizers frequently. CONCLUSION: There is under-application regarding xerosis cutis treatment in long-term care. Skin care provided by nurses, in adequate frequencies, might be helpful compared to skin care performed by the residents themselves.

[Justification of nurses' interventions for skin cleansing and skincare: Qualitative results of the SKINCARE-Pilot study]. / Begründung pflegerischer Maßnahmen zur Hautreinigung und Hautpflege.

Justification of nurses' interventions for skin cleansing and skincare: Qualitative results of the SKINCARE-Pilot study Abstract. Background: Skin care interventions are core tasks of nursing. Various factors influence the implementation of evidence-based care. Aims: To explore the perspectives of nursing staff on the relevance of skin care interventions in long-term care settings and the justification of clinical decisions about the application of such interventions. Methods: Qualitative part of a mixed methods study in three long-term-care facilities, consisting of short interviews with nursing staff members directly after nursing assistance with personal hygiene, focus group discussions with nursing staff members, and semi-structured interviews with nursing managers. The data were analyzed by means of content analysis. Results: The sample (N = 30) comprises 10 short interviews, 3 focus groups (n = 17), and 3 individual interviews. Nurses predominantly assigned a high relevance to nursing support in personal hygiene. As a basis for their decision-making, residents' needs and preferences, nurses' personal knowledge as well as own experiences and preferences were reported. Evidence-based sources of knowledge were hardly mentioned. The availability of skin cleansing and skin care products, staff and time resources, and nurse-physician cooperation were identified as influencing factors. Conclusions: Decisions about nursing support in personal hygiene seem poorly informed by evidence-based sources for clinical decision-making. Evidence-based decision support could facilitate the use of appropriate nursing interventions.

Core outcomes for pressure ulcer prevention trials: results of an international consensus study: Classification: Outcomes and qualitative research.

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.

Development, dissemination and evaluation of a smartphone-based app for pressure ulcer/injury prevention and treatment for use at the bedside.

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.

Associations between skin structural and functional changes after loading in healthy aged females at sacral and heel skin: A secondary data analysis.

AIM OF THE STUDY: 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. MATERIAL AND METHODS: 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 (rs) was used to estimate possible associations. RESULTS: Loading 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 (rs = 0.9 at heel and sacral skin) and between changes of epidermal and stratum corneum hydration at both skin areas (rs = 0.7 at sacral skin and rs = 0.5 at the heel). CONCLUSION: Two 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.

The uptake of the international pressure ulcer/injury prevention and treatment guidelines in the scientific literature: A systematic analysis of two major citation databases.

BACKGROUND: The European Pressure Ulcer Advisory Panel, the National Pressure Injury Advisory Panel and the Pan Pacific Pressure Injury Alliance developed international Clinical Practice Guidelines of the prevention and treatment of pressure ulcers/injuries in 2009, 2014, and 2019. Despite substantial dissemination efforts, evidence about guideline dissemination and uptake in the international literature is lacking. AIM: The aim of this review was to capture to the greatest detail possible the number of the citations of the three published Clinical Practice Guidelines. METHODS: The citation databases Web of Science and Scopus were searched for citations of the 2009, 2014 and 2019 Clinical Practice Guidelines including all derivative products including short versions and translations. Two separate search strategies were iteratively developed to ensure highest sensitivity. RESULTS: The Cited Reference Search in Web of Science identified hundreds of different referencing formats with more than 2000 citing articles. The Scopus search revealed 250 different reference formats and more than 2000 citation counts. After publication there was a gradual increase of citations that peaks approximately after four years. CONCLUSION: The three Clinical Practice Guidelines including all derivate versions had a substantial uptake in the scientific literature. This supports the assumption that the guideline dissemination strategies were and are successful.

An exploration of the perspectives of individuals and their caregivers on pressure ulcer/injury prevention and management to inform the development of a clinical guideline.

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.

Our contemporary understanding of the aetiology of pressure ulcers/pressure injuries.

In 2019, the third and updated edition of the Clinical Practice Guideline (CPG) on Prevention and Treatment of Pressure Ulcers/Injuries has been published. In addition to this most up-to-date evidence-based guidance for clinicians, related topics such as pressure ulcers (PUs)/pressure injuries (PIs) aetiology, classification, and future research needs were considered by the teams of experts. To elaborate on these topics, this is the third paper of a series of the CPG articles, which summarises the latest understanding of the aetiology of PUs/PIs with a special focus on the effects of soft tissue deformation. Sustained deformations of soft tissues cause initial cell death and tissue damage that ultimately may result in the formation of PUs/PIs. High tissue deformations result in cell damage on a microscopic level within just a few minutes, although it may take hours of sustained loading for the damage to become clinically visible. Superficial skin damage seems to be primarily caused by excessive shear strain/stress exposures, deeper PUs/PIs predominantly result from high pressures in combination with shear at the surface over bony prominences, or under stiff medical devices. Therefore, primary PU/PI prevention should aim for minimising deformations by either reducing the peak strain/stress values in tissues or decreasing the exposure time.

The effect of a basic skin care product on the structural strength of the dermo-epidermal junction: An exploratory, randomised, controlled split-body trial.

Skin ageing is associated with various structural alterations including a decreased strength of the dermo-epidermal adhesion increasing the risk for shear type injuries (skin tears). Topical applications of basic skin care products seem to reduce skin tear incidence. The suction blister method leads to the artificial and controlled separation of dermis and epidermis. Therefore, time to blister formation may be used as outcome measuring the strength of dermo-epidermal adhesion. We conducted an exploratory, randomised, controlled trial with a split-body design on forearms in healthy female subjects (n = 12; mean age 70.3 [SD 2.1] years). Forearms assigned to the intervention were treated twice daily with petrolatum for 8 weeks. Suction blisters were induced on forearms after 4 and 8 weeks and time to blister formation was measured. Stratum corneum and epidermal hydration were measured and epidermal thickness was assessed via optical coherence tomography. Time to blistering was longer and stratum corneum as well as epidermal hydration was consistently higher in intervention skin areas. We conclude that topical application of basic skin care products may improve mechanical adhesion of the dermo-epidermal junction and that the parameter "time to blistering" is a suitable outcome to measure dermo-epidermal adhesion strength in clinical research.

Comparing the effects of three different multilayer dressings for pressure ulcer prevention on sacral skin after prolonged loading: An exploratory crossover trial.

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-1α) 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°C and 3.8°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 µm 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-1α 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.

A Melanocortin-4 Receptor Agonist Induces Skin and Hair Pigmentation in Patients with Monogenic Mutations in the Leptin-Melanocortin Pathway.

BACKGROUND AND OBJECTIVES: Gene mutations within the leptin-melanocortin signaling pathway lead to severe early-onset obesity. Recently, a phase 2 trial evaluated new pharmacological treatment options with the MC4R agonist setmelanotide in patients with mutations in the genes encoding proopiomelanocortin (POMC) and leptin receptor (LEPR). During treatment with setmelanotide, changes in skin pigmentation were observed, probably due to off-target effects on the closely related melanocortin 1 receptor (MC1R). Here, we describe in detail the findings of dermatological examinations and measurements of skin pigmentation during this treatment over time and discuss the impact of these changes on patient safety. METHODS: In an investigator-initiated, phase 2, open-label pilot study, 2 patients with loss-of-function POMC gene mutations and 3 patients with loss-of-function variants in LEPR were treated with the MC4R agonist setmelanotide. Dermatological examination, dermoscopy, whole body photographic documentation, and spectrophotometric measurements were performed at screening visit and approximately every 3 months during the course of the study. RESULTS: We report the results of a maximum treatment duration of 46 months. Skin pigmentation increased in all treated patients, as confirmed by spectrophotometry. During continuous treatment, the current results indicate that elevated tanning intensity levels may stabilize over time. Lips and nevi also darkened. In red-haired study participants, hair color changed to brown after initiation of setmelanotide treatment. DISCUSSION: Setmelanotide treatment leads to skin tanning and occasionally hair color darkening in both POMC- and LEPR-deficient patients. No malignant skin changes were observed in the patients of this study. However, the results highlight the importance of regular skin examinations before and during MC4R agonist treatment.