Efficacy of Incontinence-Associated Dermatitis Intervention for Patients in Intensive Care: An Open-Label Pilot Randomized Controlled Trial

OBJECTIVE: To determine the feasibility of an adequately powered trial testing a long-acting cyanoacrylate skin protectant to prevent incontinence-associated dermatitis in critically ill patients. METHODS: This open-label pilot randomized controlled feasibility study was conducted in the adult ICU of an Australian quaternary referral hospital. Patients were allocated to either an intervention group or a control group (usual care). The intervention was the application of a skin protectant (a durable, ultra-thin, transparent, waterproof, no-removal barrier film). Data collected by trained research nurses included demographic and clinical variables, skin assessment, and incontinence-associated dermatitis presence and severity. Data were analyzed using descriptive and inferential statistics. RESULTS: Of the 799 patients screened, 85% were eliminated because of a short ICU stay or other exclusion criteria. The mean proportion of patients not meeting any of the exclusion criteria was 22% on each screening day. Protocol fidelity was followed for 90% of intervention participant study days. Retention of participants was 86%(31 participants out of 36), 15 in the intervention group and 16 in the control group. Enrolled patients had a mean age of 59 years, 50% were obese, 67% were male, and 36% were smokers. Two patients (11%) in the intervention group developed incontinence-associated dermatitis, compared with three (17%) in the control group. CONCLUSIONS: This study reports no significant findings between the two groups. Difficulty in recruitment and feasibility issues might be overcome with changes to inclusion criteria and study design.