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

Not Applicable

• 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; Decubitus ulcer and pressure area; Xerosis cutis; Erythema intertrigo

• Registration Number: DRKS00015680
• Lead Sponsor: Charité-Universitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-29
• Study Completion: 2021-06-04
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 405

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

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.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
o distinction is made between primary and secondary outcomes. The concept of efficacy also does not apply in this pragmatic exploratory study. <br><br>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. <br><br>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).<br><br>All outcomes will be measured at week 0 (baseline), week 12 +/- 1 and week 24 +/- 1 (end of study).

Secondary Outcome Measures

Name	Time	Method
o distinction is made between primary and secondary outcomes.