Investigation of Three Newly Developed 2-piece Convex Base-plates in Subjects With Ileostomy

Not Applicable

Completed

• Conditions: Ileostomy - Stoma

• Registration Number: NCT01957397
• Lead Sponsor: Coloplast A/S

Brief Summary

To investigate the performance and safety of the three 2-piece convex ostomy appliances

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Primary Completion: 2012-11
• Study Completion: 2012-12
• Study First Submitted: 2013-10-01
• Study First Submitted QC: 2013-10-01
• Study First Posted: 2013-10-08
• Results First Submitted: 2014-02-26
• Results First Submitted QC: 2014-02-26
• Results First Posted: 2014-04-07
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-23
• Last Update Posted: 2016-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

Subjects interested in participating in the clinical investigation must comply with the following criteria:

1. Are at least 18 years of age and have full legal capacity
2. Have had an ileostomy for at least 3 months.
3. Have used a convex ostomy appliance for the last month
4. Have given written informed consent
5. Have an ileostomy with a diameter of 33mm or less
6. Have experienced leakage (seeping) under the baseplate at least two times over the last two weeks

Exclusion Criteria

Subjects complying with the following criteria must be excluded from participation in the clinical investigation:

1. Have a loop ostomy (also called double-barrel or ostomy with two outlets)

2. Are pregnant* or breastfeeding.

3. Currently receiving, or have received within the last 2 months, chemotherapy or radiation therapy.

4. Currently receiving or have received, within the last month, systemic or local steroid treatment (adrenocortical hormone) in the peristomal area.

5. Currently suffering from peristomal skin problems (i.e. bleeding or broken skin (weeping skin)).

6. Known hypersensitivity toward any of the test products

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Degree of Leakage	14 days	The degree of leakage was measured with a 32 -point scale developed by Coloplast A/S, where 0 is the best possible outcome (no leakage) and 32 is the worst possible outcome (full leakage under the baseplate)

Trial Locations

Locations (1)

Coloplast A/S; 🇩🇰 Humlebæk, Denmark