Clinical Evaluation of a Skin Protectant for the Management of Incontinence-Associated Dermatitis: An Open-Label, Nonrandomized, Prospective Study.
Mary R Brennan, Catherine T Milne, Marie Agrell-Kann and 1 others
PMID 28267125WHAT IT FOUND
In 16 patients with incontinence-associated dermatitis, a liquid barrier film and structured cleansing were followed by median 96% reduction in skin damage score.
Among 11 able to report pain, median FACES score fell from 8 to 0. No control group; film's effect cannot be separated.
Key findings
01The primary clinician-assessed IAD score had a median 96% reduction from baseline to study end, significantly different from zero.
02Among 11 patients able to report pain at enrollment, median FACES pain score fell from 8 to 0, and the change was significant.
03The IAD score improved in 13 of 16 patients, remained unchanged in 1, and deteriorated in 2.
STILL TO COME
How it was doneWhat they foundWhat it means for RNs
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What it does not show
The study was small, with only 16 patients, and had no comparison group, so improvement cannot be separated from cleansing and structured care. The IAD score used was developed for this study and had not been tested for validity or reliability. The same scorer assessed patients, but interrater reliability was not assessed. No power analysis was done; the sample size was chosen for an initial evaluation and to allow for dropouts. Patients were followed for up to 3 weeks (21 days), and some were discharged or healed earlier, so long-term results are not shown. Pain could not be assessed in all patients: 11 of 16 could report pain at enrollment. The study was open-label, so patients and clinicians knew they were receiving the investigational film.
The easy way to misread this
Do not read the 96% median score reduction as proof that the barrier film alone treats incontinence-associated dermatitis. The study had no comparison group, the skin score tool was not validated, and all patients also received structured cleansing.