Soltanipoor Maryam, Kezic Sanja, Sluiter Judith K, Rustemeyer Thomas
Department of Dermatology, VU University Medical Centre (VUmc), De Boelelaan 1117, Amsterdam, 1081HV, The Netherlands.
Coronel Institute of Occupational Health, Academic Medical Center (AMC), Meibergdreef 9, Amsterdam, 1105 AZ, The Netherlands.
Trials. 2017 Feb 28;18(1):92. doi: 10.1186/s13063-017-1803-0.
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.
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.
医护人员由于频繁接触“湿作业”,发生职业性手部皮炎(HD)的风险很高。在医护人员中,护士的风险最高,HD的估计时点患病率在12%至30%之间。该病负担沉重,具有慢性化、病假、失业风险及生活质量受损等问题。尽管医学文献中有关于HD危险因素及皮肤护理在预防HD中的重要性的证据,但在实际中,皮肤护理方案的依从率低于30%。显然需要新的预防策略。
方法/设计:这是一项整群随机对照试验,聚焦于从事湿作业的护士。总共招募20个病房,基线时纳入504名参与研究的护士。病房将被随机分为干预组或对照组,并随访18个月。干预措施包括在病房提供乳膏并对其使用情况进行持续电子监测,同时定期反馈医护人员团队的皮肤护理表现。干预组和对照组均接受皮肤保护的基础教育(即“常规护理”)。每6个月,两组参与者都要填写关于接触湿作业和皮肤保护行为的问卷。此外,将评估皮肤状况并采集角质层样本。干预效果将通过比较从基线到12个月手部湿疹严重程度指数(HECSI评分)的变化来衡量。作为皮肤屏障损伤早期生物标志物的角质层中天然保湿因子(NMF)水平以及每个病房乳膏的总消耗量将作为次要结局进行评估。
本试验将评估一项预防医护人员手部皮炎的干预方案的临床效果。试验注册:荷兰试验注册库(NTR),识别号NTR5564。于2015年11月2日注册。