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OpenTrials
Completed

NCT Number: NCT02401412

The Advocate Study

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.

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Key information

Conditions

Ostomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lakeside Medicine Center, Kelowna, British Columbia, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Test Ostomy Barrier

Device

Control Ostomy Barrier

Device

Primary outcomes

  1. Stoma Related Cost of Care

    Time frame: 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 outcomes

  1. Peristomal Skin Complication Rate

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hollister Incorporated

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 27, 2015
Registry last updated
Jul 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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