Retrospective Cohort Noninferiority Analysis of Barrier Cream in Preventing Pressure Injuries.

OBJECTIVE: To assess the effectiveness of a dimethicone- and zinc-based barrier cream compared with hyperoxygenated fatty acids in preventing pressure injuries (PIs) in patients at high or very high risk. METHODS: Researchers conducted a retrospective noninferiority study in an inpatient acute care hospital in Spain that included hospitalized patients in nonsurgical departments with impaired mobility. RESULTS: The study authors reviewed 522 patients in a control group (hyperoxygenated fatty acids) and an experimental group (barrier cream) over a period of 7 days. The incidence of PI was 31% in the control group and 31.1% in the experimental group. The hazard ratio for developing PI was 0.84 (confidence interval, 0.61-1.17; P = .32) in the experimental group compared with the control group, meeting the criteria for noninferiority. The Kaplan-Meier estimator indicated no statistically significant difference between groups (log-rank = 0.654). CONCLUSIONS: Dimethicone- and zinc-based barrier cream was not inferior to hyperoxygenated fatty acids in preventing PIs in hospitalized patients at high or very high risk of developing them during their hospital stay.

Effects of skin moisturizer on the skin barrier dysfunction model: An evaluation of the heel via tape-stripping in healthy, young adults.

BACKGROUND: This study seeks to establish the skin barrier dysfunction model at the heel via tape-stripping (TS) by evaluating the skin moisturizing effects. MATERIALS AND METHODS: Nineteen young, female participated in the study. A sequence of TS was performed at the heel and trans-epidermal water loss (TEWL), stratum corneum (SC) hydration, and surface pH were measured. Following TS, the subjects were divided into three groups: moisturizer, emollient, and overcoat. These agents were applied daily at night, and the skin parameters were measured the next morning for a week. RESULTS: The TEWL value of TS immediately and 5 min after TS were significantly higher than what was obtained before TS, while the SC hydration after TS was significantly lower than what was obtained before TS. However, there were no significant differences in the skin parameters among the three agents on day 7 after application, with the two-way ANOVA showing no interaction among the agents and number of days. CONCLUSION: The skin barrier dysfunction model at the heel was established by TS in healthy, young adults. However, the physiological function of the skin at the heel did not change drastically and showed no differences even after continuous application for 7 days.

Identification and characterization of unknown degradation impurities in beclomethasone dipropionate cream formulation using HPLC, ESI-MS and NMR.

The present study focuses on identifying the degradation profile and pathways of unknown impurities from beclomethasone dipropionate (BDP) topical cream formulation reported under accelerated stability conditions. Six degradation impurities were observed during the accelerated stability testing of BDP topical cream formulation, and these thermally labile degradation impurities were primarily identified using a simple, effective and mass compatible isocratic reversed-phase high-performance liquid chromatography with ultraviolet detection method. The degradation impurities found in this sample were of very low concentration levels, thus the concentration of these impurities in the sample was enriched by mimicking the thermal degradation conditions to structurally elucidate the unknown impurities. These BDP thermal degradation impurities were isolated using preparative liquid chromatography and followed by pre-concentration using rota-vapour. Further, the collected thermal degradation impurities were characterized using ESI-MS, and the major impurity was identified using 1H and C13 NMR spectroscopy, and DEPT technique. Plausible degradation pathway and mechanism of each impurity from BDP has been proposed based on the obtained mass and NMR spectral data. Thus, the present method is simple and suitable to be applied towards BDP assay in various formulations, and also to investigate the thermal stability and degradation kinetics of the final drug product.

Effective tool for assessment of the quality of barrier creams - relationships between rheological, textural and sensory properties.

The efficiency of barier creams (BC) in the prevention of occupational skin diseases is closely related to their mechanical, rheological but also sensory properties. The measurement procedure we elaborated, which simulates the spreadability conditions on the skin and evaluation whether the structure reconstruction occurs (hysteresis loop test, shear rate dependence of normal force), allows the assessment of the effectivness of the BC in terms of mechanical resistance and its adhesion to the skin surface. In this thesis an effort was made to define the impact of the human factor - the product application on skin - on the efficiency of medical devices for cutaneous use. Creams' performance such as the spreadability or the feeling on the skin during and after application, which mostly determine users willingness to use them systematically and rigorously, have been linked to parameters obtained during the structure analysis and to rheological properties. Moreover an attempt has been made to correlate the values of basic textural properties with rheological parameters determined by viscoelasticity and classic flow analysis. Instrumental analysis of selected BC products demonstrated a good correlation with organoleptic tests carried out on probands. The applicability of our tool for quality evaluation of BC has been confirmed.

In vivo efficacy of biocompatible silver nanoparticles cream for empirical wound healing.

Wound healing is a complicated process that begins at the onset of injury and a continued process till complete healing. The emergence of nanotechnology has provided a new therapeutic modality to silver nanoparticles in treatment of wounds. However, the safety of these silver nanoparticles in the process of wound healing is yet to be elucidated; nevertheless, biocompatibility is the primary concern. Biosynthesis of silver nanoparticles was synthesized using aqueous clove extract and silver nitrate solution under microwave and the obtained particles size were 30-60 nm and roughly spherical in shape. The present study focused on the efficacy of biocompatible silver nanoparticles in vivo wound healing process. Consequently, this study supported the incorporation of biosynthesized silver nanoparticles in wound dressings as a cream formulation for improved healthcare.

A Quasi-experimental Study to Explore the Effect of Barrier Cream on the Peristomal Skin of Patients With a Tracheostomy.

Peristomal skin problems represent one of the most common complications of a tracheostomy. A quasi-experimental study was conducted among patients ages 18 to 65 years hospitalized in a Turkish university hospital ear-nose-throat clinic between August 15, 2013, and December 15, 2013, to compare the effect of using or not using a barrier cream on the peristomal skin with regard to pH, moisture, temperature, color, odor, turgor, infections, and lesions after tracheostomy surgery. Patients were selected using a purposeful sampling method and included if they had not undergone another operation for a complication (eg, pneumothorax, tube misplacement, hemorrhage) within 24 hours following the tracheostomy operation. In phase 1 of the study, 9 registered nurses were observed 3 times each by the researcher, who completed an observation form. From these observations and related nursing textbooks, the researcher developed a protocol entitled "Nursing Care Steps for Patients with a Tracheostomy." This protocol was followed during phase 2 of the study during which participants were alternately assigned to either the intervention (a barrier cream containing dimethicone, acrylate terpolymer, oils, paraffin, water, dicapryladipate, isopropyl palmitate, and PPG-15 stearyl ether followed by gauze) or control (gauze only) group (n = 30 each) and observed for 7 days. Demographic characteristics were gathered for each patient upon admission to the study. Peristomal skin was assessed in terms of pH, temperature, and moisture (relative humidity [RH]) using a surface pH meter, surface thermometer, and digital skin moisture tester, as well as for lesions, infection, and maceration. Findings were documented on a skin condition assessment form. Twenty-four (24) hours post surgery, the barrier cream plus gauze was applied over peristomal area in the study group and gauze dressing only in the control group. Peristomal skin pH, moisture, and temperature were within the normal range for both groups during all observations throughout the study but closer to normal ranges in the intervention group. Mean peristomal skin pH in the intervention group was significantly higher (5.452 ± 0.043) than in the control group (5.123 ± 0.057; P &.001), mean peristomal skin moisture in the control group (46.90 ± 0.132 RH) was significantly greater than in the intervention group (41.71 ± 0.774 RH; P &.001), and mean peristomal skin temperature in the control group (33.59 ± 1.3˚ C) was significantly higher than in the intervention group (31.64 ± 0.607˚ C; P &.001). In both groups, Staphylococcus epidermidis was the most commonly cultured microorganism, and S aureus was the most cultured pathological microorganism in addition to the normal skin flora. Peristomal skin condition was maintained for both the intervention and control groups. Use of a barrier cream to protect tracheostomy peristomal skin beneath absorbent dressings (eg, gauze) is recommended, but additional short-term and long-term studies are needed.

Cost-effectiveness of a Ceramide-Infused Skin Barrier Versus a Standard Barrier: Findings From a Long-Term Cost-effectiveness Analysis.

PURPOSE: To assess the cost-effectiveness of a ceramide-infused skin barrier (CIB) versus other skin barriers (standard of care) among patients who have undergone ostomy creation. DESIGN: Cost-effectiveness analysis, based on a decision-analytic model that was estimated using data from the ADVOCATE (A Study Determining Variances in Ostomy Skin Conditions And The Economic Impact) trial, which investigated stoma-related healthcare costs over 12 weeks among patients who recently underwent fecal ostomy, and from other sources. SUBJECTS AND SETTING: Analysis was based on a hypothetical cohort of 1000 patients who recently underwent fecal ostomy; over a 1-year period, 500 patients were assumed to use CIB and 500 were assumed to use standard of care. METHODS: We adapted a previous economic model to estimate expected 1-year costs and outcomes among persons with a new ostomy assumed to use CIB versus standard of care. Outcomes of interest included peristomal skin complications (PSCs) (up to 2 during the 1-year period of interest) and quality-adjusted life days (QALDs); QALDs vary from 1, indicating a day of perfect health to 0, indicating a day with the lowest possible health (deceased). Subjects were assigned QALDs on a daily basis, with the value of the QALD on any given day based on whether the patient was experiencing a PSC. Costs included those related to skin barriers, ostomy accessories, and care of PSCs. The incremental cost-effectiveness of CIB versus standard of care was estimated as the incremental cost per PSC averted and QALD gained, respectively; net monetary benefit of CIB was also estimated. All analyses were run using the perspective of an Australian payer. RESULTS: On a per-patient basis, use of CIB was expected over a 1-year period to result in 0.16 fewer PSCs, an additional 0.35 QALDs, and a savings of A$180 (Australian dollars, US $137) in healthcare costs all versus standard of care. Management with CIB provided a net monetary benefit (calculated as the product of maximum willingness to pay for 1 QALD times additional QALDs with CIB less the incremental cost of CIB) of A$228 (US $174). Probabilistic sensitivity analysis was also completed; it revealed that 97% of model runs resulted in fewer expected PSCs with CIB; 92% of these runs resulted in lower expected costs with CIB. CONCLUSIONS: Findings suggest that the CIB is a cost-effective skin barrier for persons living with an ostomy.

Quantitation of 24-Hour Moisturization by Electrical Measurements of Skin Hydration.

PURPOSE: The purpose of this study was to quantify the effects of several moisturizers on hydration of the stratum corneum by measuring their effect on electrical conductance over a 24-hour period. DESIGN: Double-blind, randomized controlled trial. SUBJECTS AND SETTING: Twenty-five healthy female volunteers aged 18 to 65 years with dry skin on the lower legs and no other known dermatologic pathology participated in the study. Additional exclusion criteria were pregnant or taking anti-inflammatory steroids. The study was carried out in a clinical research facility in Winnipeg, Manitoba, Canada. METHODS: Subjects underwent a 3-day conditioning period using a natural soap bar on the lower legs and no application of moisturizer to the skin. Participants then came to the test site and equilibrated for at least 30 minutes under controlled conditions of temperature and humidity. After baseline hydration measurements on test sites on the lower legs of each subject, a single application of each of 5 test products at a dose of 2 mg/cm was made. Skin hydration was assessed by electrical conductance measurements with a specialized probe. The probe was briefly placed on the skin surface with light pressure, and the measurement recorded in units of microsiemens (µS). Conductance was measured at 2, 4, 6, 8, and 24 hours after product applications. RESULTS: Although all but 1 of the test products increased conductance at 2 hours, only 2 moisturizers containing high levels of glycerin (products C and E) maintained increased conductance relative to baseline at 24 hours, +37.8 (P < .001) and +103.5 (P < .001), respectively. CONCLUSIONS: Moisturizers containing high levels of glycerin can provide a measurable moisturization benefit as determined by skin conductance for at least 24 hours after a single application.

Effects of a Skin Barrier Cream on Management of Incontinence-Associated Dermatitis in Older Women: A Cluster Randomized Controlled Trial.

PURPOSE: The purpose of this study was to examine the effects of a skin barrier cream with moisturization and skin-protectant characteristics for improving the severity of incontinence-associated dermatitis (IAD) pertaining to the skin physiology and appearance. We measured the following outcomes: (1) skin physiological characteristics indicating skin protection and enhancement of the skin's moisture barrier (stratum corneum hydration, dermis hydration level, transepidermal water loss, and skin pH); and (2) changes in skin appearance (the degree of erythema and pigmentation, and the sulcus cutis condition). DESIGN: Single-blind, cluster randomized controlled trial. SUBJECTS AND SETTING: The study was conducted in a long-term care facility in Japan between November 7, 2011, and May 6, 2012. We used block randomization to obtain a random sample of 6 (4 experimental and 2 control) out of 10 available wards. All subjects were elderly women with IAD of the buttock or inner thigh. We assessed 295 patients, but only 33 met inclusion criteria; 18 were allocated to the experimental group and 15 were allocated to the control group. METHODS: All participants were managed with cleansing with a skin cleanser and application of a moisturizer daily. In addition, a skin barrier cream designed to enhance the skin's moisture barrier and act as a protective barrier was applied to the skin of patients in the experimental group 3 times a day when absorptive briefs were changed. Skin physiological and appearance characteristics were scored only at the buttock or thigh area. All data were collected on days 1 and 14 of the study. RESULTS: Univariate analysis found that the erythema index was lower in the intervention group than in the control group at day 14 (P = .004). Multivariate analysis found significant associations between use of the skin barrier cream and increased stratum corneum hydration (ß= .443, P = .031), decreased skin pH (ß=-.439, P = .020), and magnitude of erythema (ß=-.451, P = .018). CONCLUSIONS: Study findings suggest that a barrier cream designed to enhance the skin's moisture barrier and act as a skin protectant increased stratum corneum hydration, reduced cutaneous pH, and reduced erythema.

Safety and risk assessment of ceramide 3 in cosmetic products.

Ceramide 3 is used mainly as a moisturizer in various cosmetic products. Although several safety studies on formulations containing pseudo-ceramide or ceramide have been conducted at the preclinical and clinical levels for regulatory approval, no studies have evaluated the systemic toxicity of ceramide 3. To address this issue, we conducted a risk assessment and comprehensive toxicological review of ceramide and pseudo-ceramide. We assumed that ceramide 3 is present in various personal and cosmetic products at concentrations of 0.5-10%. Based on previously reported exposure data, the margin of safety (MOS) was calculated for product type, use pattern, and ceramide 3 concentration. Lipsticks with up to 10% ceramide 3 (MOS = 4111) are considered safe, while shampoos containing 0.5% ceramide 3 (MOS = 148) are known to be safe. Reported MOS values for body lotion applied to the hands (1% ceramide 3) and back (5% ceramide 3) were 103 and 168, respectively. We anticipate that face cream would be safe up to a ceramide 3 concentration of 3% (MOS = 149). Collectively, the MOS approach indicated no safety concerns for cosmetic products containing less than 1% ceramide 3.

S1 guideline on occupational skin products: protective creams, skin cleansers, skin care products (ICD 10: L23, L24)--short version.

Job-related hand dermatitis heads up the list of reported occupational diseases. So-called skin products - understood to mean protective creams, skin cleansers and skin care products - are used for the primary and secondary prevention of job- related hand dermatitis. In the interests of evidence-based medicine, the only preventive measures and/or occupational skin products that should be used are those whose potential uses and efficacy are underpinned by scientific research. To this end, the Arbeitsgemeinschaft für Berufs- und Umweltdermatologie e.V. (Working Group for Occupational and Environmental Dermatology, ABD) of the DDG (German Dermatological Society) and the Deutsche Gesellschaft für Arbeits- und Umweltmedizin (German Society for Occupational and Environmental Medicine, DGAUM) have summed up the latest scientific findings and recommendations in the updated guideline. The benefit of the combined application of protective creams and skin care products in the primary and secondary prevention of work-related contact dermatitis has been widely confirmed by recent clinical-epidemiological studies. The guideline clearly explains the necessity of demonstrating the efficacy of protective creams and cleansing products by means of in vivo methods in the sense of repetitive applications. Transferable standardised testing systems designed to examine the irritation potential and thus the compatibility of occupational skin cleansers and the reduction of irritation by protective skin creams have now been developed and validated by multicentre studies for skin protection creams and cleansers. The status of the current assessment of the safety of occupational skin products is also summarised.

[Barrier creams in prevention of hand dermatoses]. / Stosowanie preparatów barierowych w profilaktyce dermatoz rak.

Contact dermatitis is a common skin disease in the workplace and at home. Due to the high incidence of skin diseases the European Union countries have taken the activity to reduce or minimize this problem by the promotion of skin protection program, based on the application of skin protection measures - barrier creams and moisturizers. Definitions, reasons, mechanism of action and duration, application of methods, as well as the efficacy of using skin protection products in different workplaces are extensively reviewed in this article. Correctly matched barrier preparations protect against harmful factors and irritants, facilitating at the same time hand washing at the end of the working day, and together with the use of suitable non-irritating detergents and skin care products are important elements contributing to the prevention of occupational skin diseases. They shouldn't be used as a primary protection against high-risk substances. Numerous creams declared as the skin protection measures are on the market, so a careful selection of appropriate effective skin protecting barrier cream for the specific situations/environments is recommended.