Enhancing SKIN health and safety in aged CARE (SKINCARE Trial): a study protocol for an exploratory cluster-randomized pragmatic trial

BACKGROUND: Aged long-term care receivers are affected by various adverse skin conditions like pressure ulcers, incontinence-associated dermatitis, dryness, intertrigo, and many more. Prevention of these skin problems and the provision of general hygiene and skin care activities are key areas of nursing practice. Numerous condition-specific guidelines are available and are implemented separately. On the other hand, there is huge overlap in terms of etiology, pathogenesis, and prevention of the skin conditions mentioned above. This leads to fragmented practice neglecting shared etiologies and prevention and treatment principles. METHODS: The overall aims of this trial are to test the feasibility and to estimate possible effects of the implementation of a comprehensive skin care and prevention strategy targeting main nursing-relevant skin problems at the same time. A two-arm cluster-randomized controlled trial will be performed in 20 nursing homes randomly selected from the population of nursing homes of the state of Berlin, comparing skin care according to the skin care and prevention strategy with standard skin care. DISCUSSION: It is expected that the implementation of this evidence-based skin care and prevention strategy will reduce the incidence of pressure ulcers, incontinence dermatitis, and other skin problems frequently related to care dependency. This trial will benefit individual patients and aged nursing home residents in general given the high prevalence and incidence of the addressed skin conditions. Findings of this exploratory trial may lay the foundation for a change in the development and evaluation of clinical standards and practices in general as it moves the perspective from individual conditions to a more comprehensive view on overlapping or coexisting health problems, in this case common skin conditions, in old-age long-term care receivers. TRIAL REGISTRATION: The study is registered at the German Clinical Trials Register https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00015680 (Deutsches Register Klinischer Studien, or DRKS; registration number: DRKS00015680, date of registration: January 29, 2019) and ClincialTrials.gov (registration number: NCT03824886, date of registration: January 31, 2019).