The Advocate Study
- Conditions
- Ostomy
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 170
Ostomy patients who:
- Have healthy peristomal skin
- Are within 12 weeks post op
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
- 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
Winter Haven Hospital
🇺🇸Winter Haven, Florida, United States
University of Chicago Medicine
🇺🇸Chicago, Illinois, United States
Indiana Health Ball Memorial University
🇺🇸Muncie, Indiana, 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
Lakeside Medicine Center
🇨🇦Kelowna, British Columbia, Canada
Pharmasave
🇨🇦Nanaimo, British Columbia, Canada
Scroll for more (2 remaining)Stoia Consultants🇺🇸Riverside, California, United States