N/A
N=170
The Advocate Study
Ostomy
Bottom Line
View on ClinicalTrials.gov: NCT02401412 ↗Enrolled (actual)
170
Serious AEs
11.8%
Results posted
Jul 2018
Primary outcome: Primary: Stoma Related Cost of Care — 223.73; 260.19 USD
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Test Ostomy Barrier (Device); Control Ostomy Barrier (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hollister Incorporated
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Stoma Related Cost of Care |
223.73; 260.19 | — |
| SECONDARY Peristomal Skin Complication Rate |
32; 41 | — |
Summary
Hollister Incorporated is studying stoma related cost of care related to a new ostomy skin barrier that is designed to maintain adhesive properties and good peristomal skin health compared to other currently marketed barriers.
Eligibility Criteria
Inclusion Criteria
Ostomy patients who:
- Have healthy peristomal skin
- Are within 12 weeks post op
Exclusion Criteria
Ostomy patients who:
- Have a fistula, wound, lesion or suspected infection in the peristomal area
- Are in-patient in healthcare facility
Data sourced from ClinicalTrials.gov (NCT02401412). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.