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van CCT (UK)

van CCT (UK)

Skincare intervention

- candidate number23347
- NTR NumberNTR5564
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-nov-2015
- Secondary IDsNL54372.018.15 
- Public TitleSkincare intervention
- Scientific Title‘Effectiveness of a skincare feedback program in healthcare workers’
- hypothesisThe proposed skincare feedback program will reduce the clinical severity of hand dermatitis compared to the ‘care as usual’
- Healt Condition(s) or Problem(s) studiedHand 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 criteriaNot performing 'wet work'' -activities
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2016
- planned closingdate1-aug-2017
- Target number of participants544
- Interventionsintervention program, consisting of provision of skin care products and regular feedback on the skin condition in health care workers
- Primary outcomeHand Eczema Severity Index score (HECSI-score)
- Secondary outcomeLevels of natural moisturizing factor (NMF) (mmol/g protein) in the skin
- Timepoints12 months
- Trial web site
- statusplanned
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Amsterdam
- Publications
- Brief summaryBackground: 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. Methods/design:

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 protective behavior.

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)
- RECORD2-nov-2015 - 4-apr-2016

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