Ceramide-Infused Skin Barrier for Use Following Ostomy Surgery: A Narrative Review of Available Data.
Ariel Berger, Nicola Sawalhi-Leckenby, Gary Inglese and 2 others
PMID 41778656WHAT IT FOUND
In ostomy pouching, a ceramide-infused barrier lowered 12-week care costs by $36.46 in a randomized trial.
The trial did not show a clear reduction in peristomal skin complication incidence. Nurses and patients reported high satisfaction.
Key findings
01The trial's primary outcome was economic impact, and mean 12-week ostomy-related costs were $36.46 lower with the ceramide barrier.
02The complication incidence difference did not meet the trial's required threshold: 40.5% with the ceramide barrier versus 55.4% with control, P=.069, threshold P<.026.
03In multinational product evaluations, mean peristomal skin DET score fell from 4.0 to 1.7 on a 0 to 15 scale after switching to the barrier.
STILL TO COME
How it was doneWhat they foundWhat it means for RNs
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What it does not show
This is a narrative review, not a new controlled trial, and it mixes published results with unpublished industry analyses. The randomized trial was powered for cost, not for peristomal skin complication incidence. The complication incidence difference did not meet the trial's predefined significance threshold. Many supportive analyses are post hoc, simulated, or based on previously unpublished manufacturer data. Product evaluations were observational switches without a control group, with provider discretion and missing responses. The one-year cost savings figure is extrapolated from 12-week data, not observed. Two authors were employees of the manufacturer during manuscript development.
Declared interests
Hollister Incorporated markets the barrier and supplied unpublished trial and product data. Two authors were Hollister employees during manuscript development; one remains employed.
The easy way to misread this
Do not read this as proof that the barrier prevents peristomal skin complications. The trial's primary outcome was cost, and the complication incidence difference did not meet the trial's required threshold. Much of the supporting evidence is manufacturer-led.