Safety and Performance of New 2-piece Ostomy Product Concept Compared With SenSura Click in Subjects With Ileostomy

Not Applicable

Completed

• Conditions: Subjects With an Ileostomy
• Interventions: Device: Coloplast A; Device: Coloplast C; Device: Coloplast B; Device: SenSura Click

• Registration Number: NCT01800890
• Lead Sponsor: Coloplast A/S

Brief Summary

The aim of the current clinical investigation is to evaluate the performance and safety of new 2-piece ostomy product concepts.

Detailed Description

The new products have been developed to reduce the degree of leakage and other problems related to ostomy appliances in people with a stoma.

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-22
• Study First Submitted QC: 2013-02-26
• Study First Posted: 2013-02-28
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Results First Submitted: 2014-04-28
• Status Verified: 2014-07
• Results First Submitted QC: 2014-07-14
• Last Update Submitted: 2014-07-14
• Results First Posted: 2014-08-06
• Last Update Posted: 2014-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

1. Have given written informed consent and signed letter of authority form.
2. Be at least 18 years of age and have full legal capacity.
3. Be able to handle the appliances themselves
4. Have an ileostomy with a diameter between 15 and 40 mm.
5. Have had their ostomy for at least three months.
6. Use minimum 1 baseplate every third day.
7. Currently use 2-piece flat mechanical coupling product with open bag and a coupling size in the inter val of 43-55mm (both extremes included)
8. Must be able to use custom cut product
9. Accept to test three 2-piece products within the study.
10. Negative result of a pregnancy test for women of childbearing age.

Exclusion Criteria

1. Use irrigation during the study (flush the stoma with water).
2. Currently receiving or have within the past 2 months received radio- and/or chemotherapy.
3. Currently receiving or have within the past month received local or systemic steroid treatment in the peristomal area.
4. Are pregnant or breastfeeding.
5. Participating in other interventional clinical investigations or have previously participated in this investigation.
6. More than three days wear time as usual change pattern.
7. Currently using ostomy belt
8. Currently using extended wear product (Sensura Xpro, Assura TERA, Dansac NovaLife X3, Hollister Flextend, Convatec Durahesive)
9. Have a loop ileostomy
10. Known hypersensitivity towards any of the test products
11. Suffer from peristomal skin problems that preclude participation in the investigation (assessed by the investigation nurse)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment sequence 1	Coloplast A	Subjects randomised to Treatment sequence 1 will test three different products: 1. Coloplast A 2. Coloplast B 3. SenSura Click The subjects test the three test products in a randomized order: ABS; BSA, SAB
Treatment sequence 2	Coloplast C	Subjects randomised to Treatment sequence 2 will test three different products: 1. Coloplast C (C) 2. Coloplast B (B) 3. SenSura Click (S) The subjects test the three test products in a randomized order: CBS; BSC, SCB
Treatment sequence 3	Coloplast A	Subjects randomised to Treatment sequence 3 will test three different products: 1. Coloplast A (A) 2. Coloplast C (C) 3. SenSura Click (S) The subjects test the three test products in a randomized order: ACS; CSA, SAC
Treatment sequence 1	Coloplast B	Subjects randomised to Treatment sequence 1 will test three different products: 1. Coloplast A 2. Coloplast B 3. SenSura Click The subjects test the three test products in a randomized order: ABS; BSA, SAB
Treatment sequence 1	SenSura Click	Subjects randomised to Treatment sequence 1 will test three different products: 1. Coloplast A 2. Coloplast B 3. SenSura Click The subjects test the three test products in a randomized order: ABS; BSA, SAB
Treatment sequence 2	SenSura Click	Subjects randomised to Treatment sequence 2 will test three different products: 1. Coloplast C (C) 2. Coloplast B (B) 3. SenSura Click (S) The subjects test the three test products in a randomized order: CBS; BSC, SCB
Treatment sequence 3	SenSura Click	Subjects randomised to Treatment sequence 3 will test three different products: 1. Coloplast A (A) 2. Coloplast C (C) 3. SenSura Click (S) The subjects test the three test products in a randomized order: ACS; CSA, SAC
Treatment sequence 2	Coloplast B	Subjects randomised to Treatment sequence 2 will test three different products: 1. Coloplast C (C) 2. Coloplast B (B) 3. SenSura Click (S) The subjects test the three test products in a randomized order: CBS; BSC, SCB
Treatment sequence 3	Coloplast C	Subjects randomised to Treatment sequence 3 will test three different products: 1. Coloplast A (A) 2. Coloplast C (C) 3. SenSura Click (S) The subjects test the three test products in a randomized order: ACS; CSA, SAC

Primary Outcome Measures

Name	Time	Method
Degree of Leakage	10 days	The degree of leakage is assessed using a 4 point leakage scale developed by Coloplast A/S.; The 4-point leakage scale has four choices; 1. No leakage; 2. Starting to leakage; 3. Leakage; 4. Sudden leakage; Leakage was assessed at every baseplate change

Trial Locations

Locations (1)

Coloplast A/S; 🇩🇰 Humlebæk, Denmark