N/A N=10 Randomized Supportive Care

An Explorative Randomized Controlled Investigation Evaluating Newly Developed Ostomy Products

Ileostomy

Bottom Line

View on ClinicalTrials.gov: NCT02351817 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2015

Primary outcome: Primary: Product Acceptance — 0; 1 participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Test A (Device); Test B (Device); Baseline (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Coloplast A/S
Primary completion: Mar 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Product Acceptance	0; 1	—

Summary

The primary objective of the investigation is to explore the acceptance of a newly developed adhesive.

Eligibility Criteria

Inclusion Criteria

Have given written informed consent and letter of authority
Be at least 18 years of age and have full legal capacity
Be able to handle the products her/himself
Have an ileostomy with a diameter between 10 and 30 mm
Willing to follow the product change schedule (one change per day)
Have had their ostomy for at least three months
Willing to use 1 piece open ostomy products during the test period
Must be able to use a custom cut product
Have intact skin
Negative result of a pregnancy test for women of childbearing age

Exclusion Criteria

Currently receiving or have within the past 2 months received radio- and/or chemotherapy
Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/ injection) treatment
Is pregnant or breastfeeding.
Is participating in other interventional clinical investigations or have previously participated in this investigation
Have a loop ileostomy
Known hypersensitivity towards any of the test products

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02351817). 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.