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barrier film, feasibility, incontinence-associated dermatitis, ICU, randomized controlled trial, skin protectant



  1. Coyer, Fiona PhD, MSc, RN
  2. Campbell, Jill PhD, RN, Grad Dip (Wound Care)
  3. Doubrovsky, Anna MPH, BSc (Hons)


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.