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

Abstract

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.