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SUBJECTS AND SETTING: Patients over 18 years old, being cared for in a facility providing nursing care 24h/day, with moderate to severe incontinence-associated dermatitis, with or without continued fecal or fecal and urinary incontinence. Twelve of the patients had epidermal skin loss and four had severe redness.
METHODS: The investigational product is a formulation based on acrylate chemistry. The barrier film application schedule was twice a week for up to 3 weeks for a maximum of 6 applications during the study period. A skin assessment tool designed for IAD was used to document each patient’s IAD score over time. The efficacy of the investigational product was evaluated in terms of IAD score improvement over the study period. In addition, complete re-epithelialization was recorded when observed, and pain scores were noted in patients able to report pain.
RESULTS: The IAD score improved in 13 of 16 patients, remained unchanged in one, and deteriorated in two (1 non-compliant and 1 died). The median percent improvement in IAD score was 96%, which was significantly different from zero (p=0.013 by Wilcoxon Signed-Rank test). Four of the patients with epidermal skin loss had complete re-epithelialization with 4-6 applications of the barrier film, and five had substantial improvement. The four patients with severe red skin returned to normal skin with 2-4 barrier film applications. Substantial pain reduction was reported by all 9 patients who reported pain at enrollment. There were no reported adverse events associated with the barrier film.
CONCLUSIONS: The formulation successfully created a protective barrier in the presence of oozing exudate and blood. The new product was effective as a protective barrier film in presence of incontinence.