A Randomized Controlled Trial Determining Variances in Ostomy Skin Conditions and the Economic Impact (ADVOCATE Trial).
Janice C Colwell, Joyce Pittman, Rose Raizman and 1 others
PMID 29300287WHAT IT FOUND
A ceramide ostomy skin barrier lowered the average 12-week stoma-related cost by $36.46 compared with control.
Skin complication rates were 40.5% vs 55.4%, but the difference was not conclusive.
Key findings
01Adjusted average 12-week stoma-related cost was $223.73 in the treatment group and $260.19 in the control group; the reported difference was $36.46 (P = .017).
02Peristomal skin complication incidence was 40.5% in the treatment group and 55.4% in the control group; the reported 14.9% difference was not statistically significant (P = .069).
03More peristomal skin complications resolved within 4 weeks in the treatment group than in the control group (53% vs 29%; P = .042).
STILL TO COME
How it was doneWhat they foundWhat it means for RNs
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What it does not show
The study stopped at 153 subjects after an interim analysis, so the cost result is based on early stopping. The peristomal skin complication incidence difference was not statistically significant, so the barrier did not clearly show it prevents complications. Costs were modeled to a 12-week period from follow-up times of 1 to 97 days, so real long-term costs are not shown. Only one manufacturer's barriers were compared, although fit options and accessories from other manufacturers were allowed. The sample was adults with new ostomies and healthy peristomal skin, so it does not show effects in patients who already had skin complications or in long-term ostomy care.
Declared interests
The supplied text names Hollister Incorporated as the barrier manufacturer but does not state funding or author conflicts.
The easy way to misread this
Do not read the lower skin complication rate as proof the barrier prevents complications. The cost result was significant, but the complication rate difference was not statistically significant (P = .069).