A Randomized Controlled Trial Determining Variances in Ostomy Skin Conditions and the Economic Impact (ADVOCATE Trial).

ABSTRACT:

Purpose

To compare ostomy-related costs and incidence of peristomal skin complications (PSCs) for ceramide-infused ostomy skin barriers and control skin barriers.

Design

The ADVOCATE trial is a multi-centered randomized controlled trial, and double-blinded international study with an adaptive design.

Subjects and setting

The sample comprised 153 adults from 25 sites from the United States, Canada, and Europe. Participants were seen in hospital and outpatient care settings.

Methods

Data were collected by investigators at each site during face-to-face visits and during telephone check-in calls between visits. Cost of care data were collected using a questionnaire developed specifically for the study. The peristomal skin was assessed using the Ostomy Skin Tool. He

SUBMITTER: Colwell JC 

PROVIDER: S-EPMC5757663 | biostudies-literature | 2018 Jan/Feb

REPOSITORIES: biostudies-literature