Enhancing skin health and safety in aged care (SKINCARE trial): A cluster-randomised pragmatic trial.

Background: Older nursing home residents are prone to develop different skin conditions at the same time, including xerosis cutis, skin tears, pressure ulcers, incontinence-associated dermatitis or intertrigo. Guidelines and recommendations mainly address these skin conditions separately. The overall aim of this study was to measure the effects of the implementation of a skincare and prevention package.

Trial Design: A two-arm cluster-randomised controlled trial was conducted.

Methods: In nursing homes being assigned to the intervention group, an evidence-based and structured skincare and prevention programme was implemented for six months. Nursing home residents in the control group received standard care as usual. Blinded dermatologists conducted head-to-toe skin assessments, and the researchers assessed skin barrier parameters including stratum corneum hydration and transepidermal water loss at the upper and lower extremities after three and six months. Outcomes included the cumulative incidence of incontinence-associated dermatitis, skin tears, pressure ulcers and intertrigo, and were presented as intention-to-treat and per protocol analysis. Skin dryness and resident-reported outcomes (pain, itch, quality of life) were assessed.

Results: A random sample of 17 nursing homes in the federal state of Berlin, Germany, was drawn and randomised in intervention (n = 9) and control groups (n = 8). In total, 165 participants were allocated to the intervention, and 149 participants were allocated to the control group. The cumulative incidence of skin tears (19.2 %, 95 % CI 12.8-27.8), pressure ulcers (13.6 %, 95 % CI 8.1-21.9) and intertrigo (27.0 %, 95 % CI 18.4-37.7) was lower in the intervention compared to the control group, with cumulative incidences of 27.2 % (95 % CI 19.3-36.9) for skin tears, 16.9 % (95 % CI 10.6-25.9) for pressure ulcer, and 37.8 % (95 % CI 27.5-49.4) for intertrigo. The incidence of incontinence-associated dermatitis was higher in the intervention group (26.3 %, 95 % CI 17.9-36.8) compared to the control group (23.1 %; 95 % CI 14.6-34.5). Mean skin dryness was lower in the intervention group but showed variation. The impact on pain, itch, and quality of life was trivial.

Conclusions: The present study results indicate that the implementation of tailored and evidence-based nursing routines improves skin health and safety in residential long-term care. Evidence suggests that multiple adverse skin conditions can be prevented by regular skin assessments and individually tailored skincare routines. Positive effects on skin dryness were observed, but skin physiology parameters did not indicate changes of the skin barrier function.

Trial Registration: This study is registered at the German Clinical Trials Register (registration number: DRKS00015680; date of registration: January 29, 2019) and ClinicalTrials.gov (NCT03824886; date of registration: January 31, 2019).