A Clinical Investigation Examining the Performance and Handling of New 2-piece Ostomy Products in 28 People With an Ileostomy.

Coloplast A/S0 sites28 target enrollmentJune 2012

ConditionsIleostomy - Stoma

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Ileostomy - Stoma
Sponsor: Coloplast A/S
Enrollment: 28
Primary Endpoint: Degree of Leakage
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

To assess the functionality and safety of the test products and also assess the products ability to collect stool without interfering with the stoma.

Registry

clinicaltrials.gov

Start Date

June 2012

End Date

August 2012

Last Updated

5 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Coloplast A/S

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Had given written informed consent
•Was at least 18 years of age
•Was able to handle the appliances themselves or with help from a caregiver (e.g. spouse)
•Had an ileostomy with a diameter between 15-45 mm
•Have had an ileostomy for at least 3 months
•Currently used a 2-piece flat appliance

Exclusion Criteria

•Used irrigation during the investigation (flush stoma with water)
•Currently received or had within the past 2 months received radio- and/or chemotherapy.
•Currently received or had within the past month received local or systemic steroid treatment in the peristomal area.
•Was pregnant or breast feeding
•Participated in other interventional studies that could interfere with this one or had previously participated in this investigation.
•Had a baseplate wear time of more than three days
•Suffered from peristomal skin problems that precluded participation in the investigation (assessed by the investigation nurse)

Outcomes

Primary Outcomes

Degree of Leakage

Time Frame: 14 days

Degree of leakage is measured on a 24 point scale where 0 represents no leakage (best possible outcome) and 24 represents leakage on the whole plate (worst possible outcome).