The Advocate Study

Ostomy Clinical Trial

Official title:

A Study Determining Variances in Ostomy Skin Conditions And The Economic Impact.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02401412
• Other study ID #: 5787-O
• Status: Completed
• Phase: N/A
• Start date: March 16, 2015
• Est. completion date: February 3, 2017

Study information

• Verified date: June 2018
• Source: Hollister Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: February 3, 2017
• Est. primary completion date: January 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ostomy

Intervention

Device:
• Test Ostomy Barrier

• Control Ostomy Barrier

Locations

Country	Name	City	State
Canada	Lakeside Medicine Center	Kelowna	British Columbia
Canada	Pharmasave	Nanaimo	British Columbia
Canada	Ostomy Care Centre	New Westminster	British Columbia
Canada	Rouge Valley Health System	Toronto	Ontario
United States	University of Chicago Medicine	Chicago	Illinois
United States	Klein's Orthopedic & Medical Supply	Cuyahoga Falls	Ohio
United States	Jupiter Medical Center	Jupiter	Florida
United States	Restored Images	Kansas City	Missouri
United States	Indiana Health Ball Memorial University	Muncie	Indiana
United States	Stoia Consultants	Riverside	California
United States	Winter Haven Hospital	Winter Haven	Florida
United States	St. Elizabeth Hospital	Youngstown	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Hollister Incorporated

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stoma Related Cost of Care	12 week stoma related cost of care. Cost of care includes treatments related to ostomy and/or PSCs (topical medications, clinic visits, and selected accessory use), social impact of ostomy and/or PSCs (missed work/ appointments), ostomy-related hospitalizations, emergency department visits, physician/clinic visits, medication use and therapies, and product utilization.	12 weeks
Secondary	Peristomal Skin Complication Rate	Observed 8 week Peristomal Skin Complication (PSC) rate. The validated Ostomy Skin Tool DET score was used to describe the status of the peristomal skin. Subjects were deemed to have had a PSC if the DET score was above zero due to anything other than normal postoperative healing and/or scar tissue, or the DET score increased above the normal score obtained at a previous visit.	8 weeks