N/A Completed N=170 Randomized Triple-blind Other

The Advocate Study

Ostomy

Source: ClinicalTrials.gov NCT02401412 ↗

Enrolled (actual)

170

Serious AEs

11.8%

Results posted

Jul 2018

Primary outcomePrimary: Stoma Related Cost of Care — 223.73; 260.19 USD

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Stoma Related Cost of Care	223.73; 260.19	—
SECONDARY Peristomal Skin Complication Rate	32; 41	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.