Investigation of Newly Developed 1-piece Convex Baseplates in Subjects With Ileostomy

Not Applicable

Completed

• Conditions: Ileostomy - Stoma
• Interventions: Device: Coloplast Test 1; Device: Coloplast Test 2

• Registration Number: NCT01994876
• Lead Sponsor: Coloplast A/S

Brief Summary

To investigate the performance and safety of two newly developed convex 1-piece ostomy appliances

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Study First Submitted: 2013-10-01
• Study First Submitted QC: 2013-11-21
• Study First Posted: 2013-11-26
• Status Verified: 2014-02
• Results First Submitted: 2014-02-26
• Results First Submitted QC: 2014-02-26
• Last Update Submitted: 2014-02-26
• Results First Posted: 2014-04-07
• Last Update Posted: 2014-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Subjects must comply with the following criteria in order to participate in the investigation:

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 33 mm or less
6. Have experience 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 (adreno-cortical hormone) in the peristomal area
5. Currently suffering from peristomal skin problems (i.e. bleeding or broken skin (weeping skin))
6. Are currently participating in another clinical investigation or has previously participated in this investigation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
First Coloplast Test 1	Coloplast Test 2	The subjects first test their own product to collect a baseline measurement The subjects are randomised to first test Coloplast Test 1 and thereafter Coloplast Test 2
First Coloplast Test 2	Coloplast Test 1	The subjects first test their own product to collect baseline measurements The subjects are randomised to first test Coloplast Test 2 and thereafter Coloplast Test 1
First Coloplast Test 1	Coloplast Test 1	The subjects first test their own product to collect a baseline measurement The subjects are randomised to first test Coloplast Test 1 and thereafter Coloplast Test 2
First Coloplast Test 2	Coloplast Test 2	The subjects first test their own product to collect baseline measurements The subjects are randomised to first test Coloplast Test 2 and thereafter Coloplast Test 1

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 point represents the best possible outcome (no leakage) and 32 represents the worst possible outcome (full leakage under baseplate)

Trial Locations

Locations (1)

QPS; 🇳🇱 Groningen, Netherlands