Comparison of two skin protection regimes for the prevention of incontinence-associated dermatitis in geriatric care: an exploratory trial (PID)

Study description Incontinence-associated dermatitis (IAD) is a frequent inflammatory skin condition in older adults with urinary and/or faecal incontinence, particularly in long-term care and geriatric acute care settings. Although topical skin protectants are widely used in routine nursing practice to prevent IAD, direct comparative evidence between commonly applied product categories remains limited. The PID trial (“Prevention of Incontinence-Associated Dermatitis in Geriatric Care”) was designed as an exploratory, three-arm, assessor-blinded, randomised controlled pragmatic trial to generate comparative effect size estimates for two commonly used skin protection strategies under real-world conditions. Participants aged 65 years and older with urinary and/or faecal incontinence and intact or mildly inflamed skin (GLOBIAD category 0–1A) were randomised in a 1:1:1 allocation ratio to: Film-forming skin protectant plus standardised incontinence care Lipophilic skin protectant plus standardised incontinence care Standardised incontinence care alone The primary outcome was the 14-day incidence of IAD category 2A or 2B, assessed using the Ghent Global IAD Categorisation Tool (GLOBIAD). Secondary outcomes included skin condition parameters, patient-reported symptoms, and feasibility indicators. The trial was conducted in Berlin, Germany, and registered at ClinicalTrials.gov (NCT05403762). Dataset description This dataset contains de-identified individual participant data underlying the primary and secondary analyses of the PID trial. Included are: Baseline demographic and clinical characteristics Randomisation group (coded) Repeated skin assessments from day 0 to day 14 Primary outcome variable (incident IAD category 2A/2B) Secondary outcomes including erythema, erosion, maceration, itch, pain, and instrumental erythema measurements