The Effects of Incontinence Pad Application on Loaded Skin With Reference to Biophysical and Biochemical Parameters: An Exploratory Cohort Study Using a Repeated-Measures Design.

PURPOSE: The purpose of this study was to evaluate temporal changes in skin responses following exposure to moisture alone or moisture in combination with mechanical loading. DESIGN: Comparison cohort with a repeated-measures design. SUBJECTS AND SETTINGS: The sample comprised 12 healthy volunteers. Participants were purposely sampled from 2 different age groups; half were 32 to 39 years old and half were 50 to 62 years old. Participants identified as White, Black, or mixed; 83% (n = 10) identified as White; 8 (67%) were female. METHODS: Four sites at the sacrum were challenged with the application of specimens taken from 2 absorbent products; the pad specimens were applied dry or saturated with synthetic urine (SU; pH = 8); a further site from the sacral skin was also selected and used as a control. Skin assessments were performed at different points in time: (1) 60 minutes after exposure to dry or SU-saturated pad specimens; (2) 60 minutes after exposure to pads and mechanical loading (application of pressure in the form of 45°C high sitting); and (3) 30 minutes after removal of all pads (recovery period). Outcome measures were transepidermal water loss (TEWL), stratum corneum (SC) hydration, erythema, pH, and skin inflammatory biomarkers measured at each of the time points described earlier. RESULTS: The control site and those exposed to dry pads showed minimal time-dependent changes irrespective of the parameter investigated. In contrast, significant increases in TEWL (P = .0000007) and SC hydration responses (P = .0000007) were detected at the sites under absorbent pad specimens after saturation with SU (exposure to moisture). In some participants, TEWL and SC hydration parameters were significantly higher during pressure application. Skin pH remained in the mildly acidic range throughout the test session, and no consistent trends were observed with erythema. Skin inflammatory biomarkers also exhibited considerable variability across participants; none changed significantly over time. Significant differences (P = .02) were also detected following the exposure of moisture in combination with pressure. CONCLUSION: We evaluated an array of parameters to identify changes following skin exposure to 2 absorbent pads in the presence and absence of SU and mechanical loading. Analysis revealed changes in skin barrier properties in the presence of moisture and/or pressure. This observation suggests a need for frequent pad changing as well as periods of skin off-loading to protect the skin health of individuals with incontinence.

Characterisation of superficial corneocyte properties over category I pressure ulcers: Insights into topographical and maturation changes.

BACKGROUND: Pressure ulcers (PUs) are chronic wounds that are detrimental to the quality of life of patients. Despite advances in monitoring skin changes, the structure and function of skin cells over the site of pressure ulcers are not fully understood. OBJECTIVE: The present study aims to evaluate local changes in the properties of superficial corneocytes in category 1 PU sites sampled from a cohort of hospitalised patients. METHODS: Cells were collected from a PU-compromised site and an adjacent control area and their topographical, maturation and mechanical properties were analysed. RESULTS: Corneocytes at the PU-compromised site were characterised by higher levels of immature cornified envelopes (p < 0.001) and greater amounts of desmoglein-1 (corneodesmosomal protein) (p < 0.001) compared to the adjacent control area. The cells at the control site presented the typical ridges-and-valleys topographical features of sacrum corneocytes. By contrast, the PU cells presented circular nano-objects at the cell surface, and, for some patients, the cell topography was deformed. CEs at the PU site were also smaller than at the control site. Although differences were not observed in the mechanical properties of the cells, those of the elderly patients were much softer compared with young subjects. CONCLUSION: This is the first study investigating the changes in corneocyte properties in category I pressure ulcers. Superficial cells at the PU sites showed altered topographical and maturation characteristics. Further studies are required to elucidate if these changes are a consequence of early loss of skin integrity or a result of mechanical and microclimate insults to the skin surface.

Spatial and temporal changes in biophysical skin parameters over a category I pressure ulcer.

In acute care facilities, the detection of pressure ulcers (PUs) relies on visual and manual examination of the patient's skin, which has been reported to be inconsistent and may lead to misdiagnosis. In skin and wound research, various biophysical parameters have been extensively employed to monitor changes in skin health. Nonetheless, the transition of these measures into care settings as part of a routine clinical assessment has been limited. This study was designed to examine the spatial and temporal changes in skin biophysical parameters over the site of a category I PU, in a cohort of hospitalised patients. Thirty patients, each presenting with a category I PU, were enrolled in the study. Skin integrity was assessed at the PU-compromised site and two adjacent areas (5 and 10 cm away). Data was collected over three sessions to examine both temporal differences and longitudinal changes. Skin integrity was assessed using two biophysical parameters, namely, transepidermal water loss (TEWL) and stratum corneum (SC) hydration. In addition, the influence of intrinsic factors, namely, incontinence and mobility status, on the parameters was evaluated. TEWL values at the sites compromised by PU were statistically significantly greater (P < .001) than corresponding values at the adjacent control sites at 5 and 10 cm, which were consistent with a normative range (<20 g/h/m2 ). By contrast, SC hydration values did not reveal clear distinctions between the three sites, with high inter-patient variation detected at the sites. Nevertheless, individual profiles were consistent across the three sessions, and the PU site was observed to be either abnormally dry or overhydrated in different individuals. No consistent temporal trend in either parameter was evident. However, intrinsic factors were shown to influence the parameters, with females, bedridden and incontinent patients presenting significantly higher TEWL and SC hydration values (P < .05). TEWL was able to identify differences in skin responses at skin sites compromised with a category I PU when compared to healthy adjacent skin sites. Accordingly, this parameter could be included in the clinical assessment for the identification of PU risk. Further studies are required to elucidate the role of hydration and skin barrier function in the development of PUs and their ability to monitor temporal changes in skin integrity.

Inflammatory biomarkers in sebum for identifying skin damage in patients with a Stage I pressure ulcer in the pelvic region: A single centre observational, longitudinal cohort study with elderly patients.

Pressure Ulcers (PU) are a major burden for affected patients and healthcare providers. Current detection methods involve visual assessments of the skin by healthcare professionals. This has been shown to be subjective and unreliable, with challenges associated with identifying erythema in darker colour skin. Although there exists a number of promising non-invasive biophysical techniques such as ultrasound, capacitance measurements, and thermography, the present study focuses on directly measuring the changes in the inflammatory status of the skin and underlying tissues. Therefore, in this study, we aim to analyse inflammatory cytokines collected through non-invasive sampling techniques to detect early signs of skin damage. Thirty hospitalised patients presenting with Stage I PU were recruited to evaluate the inflammatory response of skin at the site of damage and an adjacent healthy control site. Sebutapes were collected over three sessions to investigate the temporal changes in the inflammatory response. The panel of cytokines investigated included high-abundance cytokines, namely, IL-1α and IL-1RA, and low abundance cytokines; IL-6, IL-8, TNF-α, INF-γ, IL-33, IL-1ß and G-CSF. Spatial and temporal differences between sites were assessed and thresholds were used to determine the sensitivity and specificity of each biomarker. The results suggest significant (P < .05) spatial changes in the inflammatory response, with upregulation of IL-1α, IL-8, and G-CSF as well as down-regulation of IL-1RA over the Stage I PU compared with the adjacent control site. There were no significant temporal differences between the three sessions. Selected cytokines, namely, IL-1α, IL-1RA, IL-8, G-CSF, and the ratio IL-1α/IL-1RA offered clear delineation in the classification of healthy and Stage-I PU skin sites, with receiver operating characteristic curves demonstrating high sensitivity and specificity. There were limited influences of intrinsic and extrinsic factors on the biomarker response. Inflammatory markers provided a high level of discrimination between the sites presenting with Stage I PU and an adjacent healthy skin site, in a cohort of elderly inpatients. Indeed, the ratio of IL-1α to IL-1RA provided the highest sensitivity and specificity, indicative that inflammatory homeostasis is affected at the PU site. There was a marginal influence of intrinsic and extrinsic factors, demonstrating the localised effects of the inflammation. Further studies are required to investigate the potential of inflammatory cytokines incorporated within Point of Care technologies, to support routine clinical use.

Nano-adjuvanted dry powder vaccine for the mucosal immunization against airways pathogens.

Nasal vaccination has been shown to provide optimal protection against respiratory pathogens. However, mucosal vaccination requires the implementation of specific immunization strategies to improve its effectiveness. Nanotechnology appears a key approach to improve the effectiveness of mucosal vaccines, since several nanomaterials provide mucoadhesion, enhance mucosal permeability, control antigen release and possess adjuvant properties. Mycoplasma hyopneumoniae is the main causative agent of enzootic pneumonia in pigs, a respiratory disease responsible for considerable economic losses in the pig farming worldwide. The present work developed, characterized, and tested in vivo an innovative dry powder nasal vaccine, obtained from the deposition on a solid carrier of an inactivated antigen and a chitosan-coated nanoemulsion, as an adjuvant. The nanoemulsion was obtained through a low-energy emulsification technique, a method that allowed to achieve nano droplets in the order of 200 nm. The oil phase selected was alpha-tocopherol, sunflower oil, and poly(ethylene glycol) hydroxystearate used as non-ionic tensioactive. The aqueous phase contained chitosan, which provides a positive charge to the emulsion, conferring mucoadhesive properties and favoring interactions with inactivated M. hyopneumoniae. Finally, the nanoemulsion was layered with a mild and scalable process onto a suitable solid carrier (i.e., lactose, mannitol, or calcium carbonate) to be transformed into a solid dosage form for administration as dry powder. In the experimental study, the nasal vaccine formulation with calcium carbonate was administered to piglets and compared to intramuscular administration of a commercial vaccine and of the dry powder without antigen, aimed at evaluating the ability of IN vaccination to elicit an in vivo local immune response and a systemic immune response. Intranasal vaccination was characterized by a significantly higher immune response in the nasal mucosa at 7 days post-vaccination, elicited comparable levels of Mycoplasma-specific IFN-γ secreting cells and comparable, if not higher, responsiveness of B cells expressing IgA and IgG in peripheral blood mononuclear cells, with those detected upon a conventional intramuscular immunization. In conclusion, this study illustrates a simple and effective strategy for the development of a dry powder vaccine formulation for nasal administration which could be used as alternative to current parenteral commercial vaccines.

Characterisation of superficial corneocytes in skin areas of the face exposed to prolonged usage of respirators by healthcare professionals during COVID-19 pandemic.

INTRODUCTION: During the COVID-19 pandemic healthcare workers (HCWs) have used respiratory protective equipment for prolonged periods, which has been associated with detrimental effects on the underlying skin. The present study aims to evaluate changes in the main cells (corneocytes) of the stratum corneum (SC) following prolonged and consecutive use of respirators. METHODS: 17 HCWs who wore respirators daily during routine hospital practice were recruited to a longitudinal cohort study. Corneocytes were collected via tape stripping from a negative control site (area outside the respirator) and from the cheek which was in contact with the device. Corneocytes were sampled on three occasions and analysed for the level of positive-involucrin cornified envelopes (CEs) and the amount of desmoglein-1 (Dsg1), as indirect measurements of immature CEs and corneodesmosomes (CDs), respectively. These were compared to biophysical measurements (Transepidermal water loss, TEWL, and SC hydration) at the same investigation sites. RESULTS: A large degree of inter-subject variability was observed, with maximum coefficients of variation of 43% and 30% for the level of immature CEs and Dsg1, respectively. Although it was observed that there was not an effect of prolonged respirator usage on the properties of corneocytes, the level of CDs was greater at the cheek than the negative control site (p < 0.05). Furthermore, low levels of immature CEs correlated with greater TEWL values after prolonged respirator application (p < 0.01). It was also noted that a smaller proportion of immature CEs and CDs was associated with a reduced incidence of self-reported skin adverse reactions (p < 0.001). CONCLUSIONS: This is the first study that investigated changes in corneocyte properties in the context of prolonged mechanical loading following respirator application. Although differences were not recorded over time, the levels of CDs and immature CEs were consistently higher in the loaded cheek compared to the negative control site and were positively correlated with a greater number of self-reported skin adverse reactions. Further studies are required to evaluate the role of corneocyte characteristics in the evaluation of both healthy and damaged skin sites.

Biophysical and biochemical changes in skin health of healthcare professionals using respirators during COVID-19 pandemic.

BACKGROUND: Personal protective equipment, including respirator devices, has been used to protect healthcare workers (HCWs) during the COVID-19 pandemic. These are fitted to skin sites on the face to prevent airborne transmission but have resulted in reports of discomfort and adverse skin reactions from their continued usage. The present study addresses the objective changes in both the structural integrity and biological response of the skin following prolonged and consecutive use of respirators. MATERIALS AND METHODS: A longitudinal cohort study, involving 17 HCWs who wear respirators daily, was designed. Changes in the barrier properties and biological response of the skin were assessed at three facial anatomical sites, namely, the nasal bridge, left cheek and at a location outside the perimeter of respirator. Assessments were made on three different sessions corresponding to the first, second and third consecutive days of mask usage. Skin parameters included transepidermal water loss (TEWL), stratum corneum (SC) hydration and erythema, as well as cytokine biomarkers sampled from sebum using a commercial tape. RESULTS: The cheek and the site outside the perimeter covered by the respirator presented minimal changes in skin parameters. By contrast, significant increases in both the TEWL (up to 4.8 fold) and SC hydration (up to 2.7 fold) were detected at the nasal bridge on the second consecutive day of respirator-wearing. There was a high degree of variation in the individual expression of pro-and anti-inflammatory cytokines. Increasing trends in nasal bridge TEWL values were associated with the body mass index (p < 0.05). CONCLUSIONS: The most sensitive objective parameter in detecting changes in the skin barrier proved to be the increase in TEWL at the nasal bridge, particularly on the second day of consecutive respirator usage. By contrast, other measures of skin were less able to detect remarkable variations in the barrier integrity. Consideration for protecting skin health is required for frontline workers, who continue to wear respirators for prolonged periods over consecutive days during the pandemic.

The influence of gender and ethnicity on facemasks and respiratory protective equipment fit: a systematic review and meta-analysis.

INTRODUCTION: Black, Asian and minority ethnic (BAME) people are disproportionately affected by COVID-19. Respiratory protective equipment (RPE) has conventionally been developed for a predominantly white male population that does not represent the healthcare workforce. The literature was reviewed to determine the protection offered to female and BAME users. METHODS: Five databases were searched. Eligible studies related to respirator fit in the context of anthropometrics, gender and ethnicity. Meta-analysis was performed for gender-based anthropometric differences. A priori protocol registration was not performed. RESULTS: 32 studies were included and anthropometric data was extracted from 15 studies. Meta-analysis revealed 14 anthropometric measurements were significantly smaller for females. Mean differences ranged from 0.37 mm to 22.05 mm. Gender-based anthropometric differences did not always translate to lower fit factor scores, with 12 studies reporting worse performance and fit for females and 10 reporting no gender effect. No studies provided disaggregate anthropometric data by ethnic group. Pass rates (PR) were low or moderate in 12 BAME or mixed-ethnicity cohorts. 14 studies reported associations between facial dimensions (FD) and respirator fit. Three comparative studies showed lower PR among selective BAME people. 18 studies reported RPE performance differed with model and design. Most studies did not prespecify inclusion/exclusion criteria. Small sample size and lack of justification or power calculations was a concern. Significant heterogeneity in study designs limited comparisons, particularly relating to respirator selection or availability and defining study outcomes relating to RPE performance. CONCLUSION: The literature reports on largely Caucasian or single ethnic populations, and BAME people remain under-represented, limiting comparisons between ethnic groups. Facial anthropometrics vary between gender and likely between ethnicity, which may contribute to lower PR among females and ethnic minorities, particularly Asians. There is a need for studies including a broader spectrum of ethnicities and for consideration of female and BAME users during RPE development.

The identification of biophysical parameters which reflect skin status following mechanical and chemical insults.

BACKGROUND: Skin is constantly exposed to mechanical and chemical insults, in the form of prolonged loading, overhydration or exposure to irritants. An array of non-invasive biophysical tools has been adopted to monitor the changes in skin response. The present study aims to identify a set of robust parameters sensitive to mechanical and chemical challenges to skin integrity. MATERIALS AND METHODS: Eleven healthy participants were recruited to evaluate the skin response following mechanical loading, tape stripping, overhydration and chemical irritation. Forearm skin responses were recorded at baseline and at three time points following the insult. Measurements included transepidermal water loss, sub-epidermal moisture, erythema and laser Doppler imaging. Thresholds were informed by basal values, and the sensitivity of parameters to detect skin changes was evaluated. RESULTS: High degree of variability in skin response was observed with selected biophysical parameters, such as sub-epidermal moisture, laser Doppler imaging and erythema, even in the absence of an applied insult. Temporal skin response revealed distinct response profiles during each evoked insult. Indeed, the sensitivity of the biophysical parameters was influenced by the threshold values and time point of measurement. Some statistically significant correlations were determined between the biophysical parameters. CONCLUSION: The study revealed that thresholds derived from single biophysical parameters were limited in detecting skin changes following insults. A complementary evaluation using combined parameters has the potential to provide a more sensitive assessment. Further research is required to identify robust biophysical parameters, to aid the early detection of skin damage in clinical settings.

Anatomical variability of sub-epidermal moisture and its clinical implications.

BACKGROUND: Technologies have been developed to monitor changes in dermal oedema, indicative of the early signs of pressure ulcers. However, there is limited information on the effects of regional differences in tissue morphology on these sub-epidermal moisture (SEM) parameters. This study was designed to investigate the absolute SEM readings across different anatomical sites using a commercial device. METHODS: Twenty-four healthy participants were recruited to evaluate basal SEM values at different bony prominences, sampled by an experienced operator. RESULTS: Distinct differences were observed in unloaded SEM values across different anatomical sites, notably between the upper and lower extremities. A high degree of variability was observed in particular sites, such as the heels. Moreover, SEM values at certain locations revealed significant relationships with age, BMI and gender (p < 0.05). CONCLUSION: The study revealed a high level of variability between and within anatomical sites in a healthy cohort of participants. Determining the changes in local skin and sub-dermal tissue status using SEM may require consideration of both site specific and individual demographic factors, with further research needed in cohorts at risk of pressure ulcers.

Personal protective equipment related skin reactions in healthcare professionals during COVID-19.

Since the outbreak of COVID-19 pandemic, clinicians have had to use personal protective equipment (PPE) for prolonged periods. This has been associated with detrimental effects, especially in relation to the skin health. The present study describes a comprehensive survey of healthcare workers (HCWs) to describe their experiences using PPE in managing COVID-19 patients, with a particular focus on adverse skin reactions. A 24-hour prevalence study and multi-centre prospective survey were designed to capture the impact of PPE on skin health of hospital staff. Questionnaires incorporated demographics of participants, PPE type, usage time, and removal frequency. Participants reported the nature and location of any corresponding adverse skin reactions. The prevalence study included all staff in intensive care from a single centre, while the prospective study used a convenience sample of staff from three acute care providers in the United Kingdom. A total of 108 staff were recruited into the prevalence study, while 307 HCWs from a variety of professional backgrounds and demographics participated in the prospective study. Various skin adverse reactions were reported for the prevalence study, with the bridge of the nose (69%) and ears (30%) being the most affected. Of the six adverse skin reactions recorded for the prospective study, the most common were redness blanching (33%), itchiness (22%), and pressure damage (12%). These occurred predominantly at the bridge of the nose and the ears. There were significant associations (P < .05) between the adverse skin reactions with both the average daily time of PPE usage and the frequency of PPE relief. The comprehensive study revealed that the use of PPE leads to an array of skin reactions at various facial locations of HCWs. Improvements in guidelines are required for PPE usage to protect skin health. In addition, modifications to PPE designs are required to accommodate a range of face shapes and appropriate materials to improve device safety.