Skip to content

Enhancing SKIN health and safety in aged CARE: An exploratory cluster randomized pragmatic trial in aged nursing home residents (SKINCARE)

Enhancing SKIN health and safety in aged CARE: An exploratory cluster randomized pragmatic trial in aged nursing home residents (SKINCARE) - SKINCARE

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00015680
Enrollment
500
Registered
2019-01-29
Start date
2019-04-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin health in nursing home residents, especially: Pressure ulcer, xerosis cutis (dry skin), incontinence-associated dermatitis, skin tears and intertrigo. L89 L85.3 L30.4

Interventions

Group 1: Experimental intervention: Interventions on nursing home level: - Adaption of skin care algorithm to local conditions and requirements - Educational sessions for nurses and other care givers

Sponsors

Charité-Universitätsmedizin Berlin
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Being resident of the respective nursing home 2. Being 65+ years old 3. Care degree 2 or higher (according to the German Social Code Book XI) 4. Written informed consent given by themselves or on their behalf by legal representatives

Exclusion criteria

Exclusion criteria: 1. Residents at the end of life (dying persons) 2. Any dermatological condition or skin affection requiring dermatological treatment 3. Known intolerances to any possible irritating product ingredients, e.g. urea or lactate buffer or known hypersensitivity to any product ingredients e.g. sorbid acid or cetylstearyl alcohol.

Design outcomes

Primary

MeasureTime frame
No distinction is made between primary and secondary outcomes. The concept of efficacy also does not apply in this pragmatic exploratory study. Clinical outcomes include the cumulative incidence of pressures ulcers, incontinence-associated dermatitis, intertrigo, skin tears and the severity of dry skin. Skin barrier characteristics (pH, stratum corneum hydration, transepidermal water loss) will be measured. Patient reported outcomes include quality of life (WHO-Five Wellbeing Index for cognitiv healthy residents, QUALIDEM tool for cognitiv impaired residents), itch (5-D itch scale for cognitiv healthy residents) and pain (numeric rating scale for cognitiv healthy residents, verbal rating scale for cognitiv impaired residents). All outcomes will be measured at week 0 (baseline), week 12 +/- 1 and week 24 +/- 1 (end of study).

Secondary

MeasureTime frame
No distinction is made between primary and secondary outcomes.

Countries

Germany

Contacts

Public ContactJan Kottner

Institut für Klinische Pflegewissenschaft, Charité – Universitätsmedizin Berlin

jan.kottner@charite.de+49 (0)30 450 529 411

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 3, 2026