The Advocate Study

Hollister

Status: Completed

Conditions: Ostomy

Treatments: Device: Test Ostomy Barrier; Device: Control Ostomy Barrier

Study type: Interventional

Funder types: Industry

Identifiers

NCT02401412

5787-O

Details and patient eligibility

About

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.

Enrollment: 170 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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170 participants in 2 patient groups

Test Ostomy Barrier

Other group

Description:

The test product is a new Hollister ostomy barrier.

Treatment:

Device: Test Ostomy Barrier

Control Ostomy Barrier

Other group

Description:

The control product is a currently marketed Hollister ostomy barrier.

Treatment:

Device: Control Ostomy Barrier