Barrier damaging effects of n-propanol in occlusion-modified tandem repeated irritation test: Modulation by exposure factors and atopic skin disease.

BACKGROUND: Recent studies provide evidence for significant and previously underestimated barrier damaging effects of repeated exposure to 60% n-propanol in healthy skin in vivo. OBJECTIVES: To investigate further the cumulative effects of a range of n-propanol concentrations relevant at the workplace in healthy and atopic dermatitis (AD) individuals, and study the modulation of the outcomes by co-exposure and host-related factors. METHODS: Healthy adult and AD volunteers were exposed to n-propanol concentrations from 30% to 75% in occlusion-modified tandem repeated irritation test with measurements of erythema, transepidermal water loss, capacitance, and the natural moisturizing factor (NMF) levels at baseline and after 96 hours. RESULTS: n-Propanol exerted significant barrier damaging effects even at the lowest concentration in both groups. Exposure to all n-propanol concentrations significantly reduced the NMF levels. Preceding low-grade trauma by occlusion/water exposure reduced the skin irritation threshold in both groups. The differences in the severity of the barrier function impairment after exposure to the same concentrations under the same conditions between the AD and control groups were significant. CONCLUSIONS: The negative effects of cumulative exposure to n-propanol in healthy and atopic skin shown in the study suggest the need for critical re-evaluation of its irritant properties in vivo.

Effectiveness of a skin care programme for the prevention of contact dermatitis in healthcare workers (the Healthy Hands Project): A single-centre, cluster randomized controlled trial.

BACKGROUND: Healthcare workers (HCWs) are at risk of developing hand dermatitis (HD). Guidelines recommend moisturizers to prevent HD, but in practice their effectiveness has been poorly investigated. OBJECTIVES: To assess whether an intervention aimed at improving skin care leads to a reduction in HD severity. METHODS: In this 1-year randomized controlled trial, 9 wards (285 HCWs) were allocated to an intervention group (IG), and 10 wards (216 HCWs) were allocated to the control group (CG). The intervention included provision of cream dispensers with electronic monitoring of use, regularly communicated to the HCWs. The primary and secondary outcomes were change from baseline in Hand Eczema Severity Index (HECSI) score (ΔHECSI) and change in natural moisturizing factor (NMF) level (ΔNMF). RESULTS: At 12 months, the rates of loss to follow-up were 41% and 39% in the IG and the CG, respectively. The HECSI score was reduced in the IG by -6.2 points (95%CI: -7.7 to -4.7) and in the CG by -4.2 points (95%CI: -6.0 to -2.4). There was no significant difference in ΔHECSI or ΔNMF between the groups. Relative improvement in the HECSI score was significantly higher in the IG than in the CG (56% vs 44%). In a subgroup of HCWs with mild HD, the IG showed a larger HECSI score decrease than the CG (P < 0.001). CONCLUSION: Although there was no significant effect on the primary outcomes, the intervention showed overall positive effects on the HECSI score.

Evaluating the effect of electronic monitoring and feedback on hand cream use in healthcare workers: Healthy Hands Project.

BACKGROUND: Healthcare workers (HCWs) are at high risk of developing hand dermatitis (HD). Current guidelines on HD prevention recommend the use of emollients; however, in practice, adherence is poor. OBJECTIVE: To assess whether the provision of creams, electronic monitoring and feedback on cream consumption can improve skin care in HCWs. METHODS: A cluster randomized controlled trial was conducted on 19 academic hospital wards, including 501 HCWs, for 12 months. The intervention wards (n = 9; 285 HCWs) were provided with hand cream dispensers equipped with an electronic system to monitor use, which was regularly communicated to the HCWs by the use of posters. The process outcomes were self-reported cream consumption in both groups, and electronically measured consumption per ward in the intervention group (IG) vs the control group (CG). RESULTS: Self-reported cream use at follow-up was significantly higher in the IG than in the CG, before (odds ratio [OR] 2.27; 95%CI: 1.29-3.97; P = 0.004) and during (OR 3.30; 95%CI: 1.80-6.06, P < 0.001) the shift, whereas at baseline there was no difference between the groups. In the IG, electronically measured cream use was, on average, 0.4 events per shift per HCW. CONCLUSION: The intervention improved hand cream use, and may therefore be considered as a practical strategy to promote skin care in HCWs. Notwithstanding this, the application frequency remained lower than recommended in the present study and current guidelines.

Statistical analysis plan for the Healthy Hands Project; single centre cluster-randomised clinical trial of a skin care program for the prevention of contact dermatitis in health care workers.

BACKGROUND: The Healthy Hands Project (HHP) is a randomised clinical trial aiming to determine the effectiveness of an intervention program in the prevention of hand dermatitis in healthcare workers (HCWs). The intervention is comprised of placing dispensers with hand creams on wards combined with continuous electronic monitoring of cream consumption and regular feedback to HCWs. The clinical severity (HECSI score) was used as the primary outcome and natural moisturising factor (NMF) levels as the secondary outcome. The study protocol for the cluster-randomised controlled trial of HHP was published in Trials in 2017. This article describes the detailed statistical analysis plan for the HHP trial. METHODS/DESIGN: The HHP is a single-centre, cluster-randomised controlled trial with two parallel groups and blinded outcome assessment. This update article presents (1) the descriptive statistics of the primary and secondary outcomes, (2) the statistical models used for the analysis of the main outcomes, (3) sensitivity analyses on the effect of observed exposure to wet work, (4) handling of missing data including sensitivity analysis and (5) an updated power calculation. This statistical analysis plan was written prior to unblinding of the study. DISCUSSION: This paper presents a comprehensive statistical analysis plan for the data resulting from the HHP trial. It supports transparency in reporting by clarifying differences between the previously published protocol and the proposed actual statistical analyses. TRIAL REGISTRATION: Netherlands Trial Register (NTR), identification number NTR5564 . Registered on 2 November 2015.

Specific barrier response profiles after experimentally induced skin irritation in vivo.

BACKGROUND: Recently, natural moisturizing factors (NMFs) and corneocyte surface topography were suggested as biomarkers for irritant dermatitis. OBJECTIVES: To investigate how exposure to different irritants influences corneocyte surface topography, NMF levels and the barrier function of human skin in vivo. METHODS: Eight healthy adult volunteers were exposed to aqueous solutions of 60% n-propanol, 0.5% sodium lauryl sulfate (SLS), 0.15% sodium hydroxide, and 2.0% acetic acid, and distilled water, in a repeated irritation test over a period of 96 hours. Erythema, transepidermal water loss (TEWL), skin hydration, the dermal texture index (DTI) and NMF levels were measured at baseline, and after 24 and 96 hours. RESULTS: SLS and sodium hydroxide had the most pronounced effects on erythema and TEWL. Although n-propanol caused only slight changes in TEWL and erythema, it showed pronounced effects on skin hydration, NMF levels, and the DTI. NMF was the only parameter that was significantly altered by all investigated irritants. The changes in the DTI were inversely associated with NMF levels and skin hydration. CONCLUSION: Skin barrier impairment and the inflammatory response are irritant-specific, emphasizing the need for a multiparametric approach to the study of skin irritation. NMF levels seem to be the most sensitive parameter in detecting irritant-induced skin barrier alterations.

The effectiveness of a skin care program for the prevention of contact dermatitis in health care workers (the Healthy Hands Project): study protocol for a cluster randomized controlled trial.

BACKGROUND: Health care workers (HCW) are at high risk for developing occupational hand dermatitis (HD) due to frequent exposure to 'wet work'. Amongst HCWs, nurses are at highest risk, with an estimated point prevalence of HD ranging between 12 and 30%. The burden of disease is high with chronicity, sick leave, risk of unemployment and impaired quality of life. Despite evidence from the medical literature on the risk factors and the importance of skin care in the prevention of HD, in practice, compliance to skin care protocols are below 30%. New preventive strategies are obviously needed. METHODS/DESIGN: This is a cluster randomized controlled trial, focusing on nurses performing wet work. In total, 20 wards are recruited to include 504 participating nurses in the study at baseline. The wards will be randomized to an intervention or a control group and followed up for 18 months. The intervention consists of the facilitation of creams being available at the wards combined with the continuous electronic monitoring of their consumption with regular feedback on skin care performance in teams of HCWs. Both the intervention and the control group receive basic education on skin protection (as 'care as usual'). Every 6 months, participants of both groups will fill in the questionnaires regarding exposure to wet work and skin protective behavior. Furthermore, skin condition will be assessed and samples of the stratum corneum collected. The effect of the intervention will be measured by comparing the change in Hand Eczema Severity Index (HECSI score) from baseline to 12 months. The Natural Moisturizing Factor (NMF) levels, measured in the stratum corneum as an early biomarker of skin barrier damage, and the total consumption of creams per ward will be assessed as a secondary outcome. DISCUSSION: This trial will assess the clinical effectiveness of an intervention program to prevent hand dermatitis among health care workers TRIAL REGISTRATION: Netherlands Trial Register (NTR), identification number NTR5564 . Registered on 2 November 2015.