The Advocate Study

Not Applicable

Completed

• Conditions: Ostomy
• Interventions: Device: Control Ostomy Barrier; Device: Test Ostomy Barrier

• Registration Number: NCT02401412
• Lead Sponsor: Hollister Incorporated

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-16
• Study First Submitted: 2015-03-24
• Study First Submitted QC: 2015-03-24
• Study First Posted: 2015-03-27
• Primary Completion: 2017-01-20
• Study Completion: 2017-02-03
• Results First Submitted: 2018-04-05
• Status Verified: 2018-06
• Results First Submitted QC: 2018-06-13
• Last Update Submitted: 2018-06-13
• Results First Posted: 2018-07-11
• Last Update Posted: 2018-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Ostomy Barrier	Control Ostomy Barrier	The control product is a currently marketed Hollister ostomy barrier.
Test Ostomy Barrier	Test Ostomy Barrier	The test product is a new Hollister ostomy barrier.

Primary Outcome Measures

Name	Time	Method
Stoma Related Cost of Care	12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Peristomal Skin Complication Rate	8 weeks	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.

Trial Locations

Locations (12)

Stoia Consultants; 🇺🇸 Riverside, California, United States

Jupiter Medical Center; 🇺🇸 Jupiter, Florida, United States

Indiana Health Ball Memorial University; 🇺🇸 Muncie, Indiana, United States

Winter Haven Hospital; 🇺🇸 Winter Haven, Florida, United States

University of Chicago Medicine; 🇺🇸 Chicago, Illinois, United States

Restored Images; 🇺🇸 Kansas City, Missouri, United States

Klein's Orthopedic & Medical Supply; 🇺🇸 Cuyahoga Falls, Ohio, United States

St. Elizabeth Hospital; 🇺🇸 Youngstown, Ohio, United States

Rouge Valley Health System; 🇨🇦 Toronto, Ontario, Canada

Lakeside Medicine Center; 🇨🇦 Kelowna, British Columbia, Canada

Pharmasave; 🇨🇦 Nanaimo, British Columbia, Canada

Ostomy Care Centre; 🇨🇦 New Westminster, British Columbia, Canada