N/A N=28 Randomized Supportive Care

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

Ileostomy - Stoma

Bottom Line

View on ClinicalTrials.gov: NCT02064231 ↗

Enrolled (actual)

Serious AEs

1.7%

Results posted

Apr 2014

Primary outcome: Primary: Degree of Leakage — 6.4; 3.4; 7.0; 7.0 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Coloplast Test A (Device); Coloplast Test B (Device); Own product (Device); Coloplast Test C (Device); Coloplast Test D (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Coloplast A/S
Primary completion: Aug 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Degree of Leakage	6.4; 3.4; 7.0; 7.0; 1.9	—

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.

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02064231). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.