|- candidate number||23347|
|- NTR Number||NTR5564|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||2-nov-2015|
|- Secondary IDs||NL54372.018.15 |
|- Public Title||Skincare intervention |
|- Scientific Title||‘Effectiveness of a skincare feedback program in healthcare workers’|
|- hypothesis||The proposed skincare feedback program will reduce the clinical severity of hand dermatitis compared to the ‘care as usual’
|- Healt Condition(s) or Problem(s) studied||Hand eczema, Intervention|
|- Inclusion criteria||- Informed written consent|
- Age between 18-65 years
- exposure to wet work activities
- employment as nurse at the participating wards
|- Exclusion criteria||Not performing 'wet work'' -activities|
|- mec approval received||no|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-feb-2016|
|- planned closingdate||1-aug-2017|
|- Target number of participants||544|
|- Interventions||intervention program, consisting of provision of skin care products and regular feedback on the skin condition in health care workers
|- Primary outcome||Hand Eczema Severity Index score (HECSI-score) |
|- Secondary outcome||Levels of natural moisturizing factor (NMF) (mmol/g protein) in the skin |
|- Timepoints||12 months|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||MD Maryam Soltanipoor|
|- CONTACT for SCIENTIFIC QUERIES||MD Maryam Soltanipoor|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|Academic Medical Center (AMC), Amsterdam|
|- Brief summary||Background:
Healthcare Workers (HCW) are at high risk for developing occupational hand dermatitis (HD) due to
frequent exposure to wet work, including irritants and allergens. Amongst HCW, nurses are particularly at
high risk of HD, with an estimated point prevalence between 12-30%. The burden of disease is high with
risk of chronicity, sick leave, unemployment and impaired quality of life. Despite evidence from literature on
the importance of skin protection and care in the prevention of HD, compliance to skincare protocols in
practice is below 30%. New strategies are obviously needed.
Trial design: This is a randomized clustered controlled trial.
Objectives: To assess effects of an intervention program on skin condition in HCW, consisting of regular
feedback on the consumption of provided hand creams.
Participants: The trial includes nurses performing wet work. A total of 34 wards in the Free
university academic center (VUmc, Amsterdam) are recruited as participating sites. The wards are
randomized to an intervention vs control group and followed up to18 months.
Intervention: The experimental intervention comprised provision of hand creams in dispensers at the
wards with regular training and feedback, including reports of the electronically monitored consumption.
Both the experimental and the control group receive basic education on skin protection (as care as usual).
Every six months all participants will fill in the questionnaires regarding exposure to irritants and skin
Outcomes: The primary outcome is the change in Hand Eczema Severity Index (HECSI-score) from
baseline to 12 months. The secondary outcomes are the Natural Moisturizing Factor (NMF) levels in the
stratum corneum as a biomarker of skin barrier damage and the total consumption of creams per ward.
Conflicts of interest: The authors have declared no conflicts of interest
|- Main changes (audit trail)|
|- RECORD||2-nov-2015 - 4-apr-2016|