Investigating the Safety and Performance of Two New 1-piece Ostomy Products Compared With SenSura 1-piece

Not Applicable

Completed

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

• Registration Number: NCT01957488
• Lead Sponsor: Coloplast A/S

Brief Summary

The aim of the current investigation is to investigate the performance of two new 1-piece ostomy products

Detailed Description

The present investigation aims at testing the performance and safety of the two new 1-piece ostomy products

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-08-06
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Study First Submitted QC: 2013-10-01
• Study First Posted: 2013-10-08
• Results First Submitted: 2014-09-11
• Results First Submitted QC: 2014-09-11
• Results First Posted: 2014-09-17
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-26
• Last Update Posted: 2020-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 183

Inclusion Criteria

1. Have given written informed consent and signed letter of authority (mandatory in DK)
2. Be at least 18 years of age and have full legal capacity.
3. Be able to handle the products themselves
4. Have an ileostomy with a diameter between 10 and 40 mm.
5. Have had their ostomy for at least three months.
6. Have within the last month used a 1-piece flat product with open bag
7. Currently using midi or maxi bags
8. Willing to use minimum 1 product every second day, i.e. maximum 2 days wear time.
9. Be suitable for participation in the investigation
10. Must be able to use custom cut product
11. Negative result of a pregnancy test for women of childbearing age (only DK)

Exclusion Criteria

1. Currently receiving or have within the past 2 months received radio- and/or chemotherapy.
2. Currently receiving or have within the past month received systemic steroid or local treatment in the peristomal area
3. Are pregnant or breastfeeding
4. Participating in other interventional clinical investigations or have previously participated in this investigation
5. Has participated in the previous explorative Coloplast studies CP236 and CP237
6. Are currently or during the study using ostomy belt
7. Has a stoma below skin surface
8. Currently suffering from peristomal skin problems (i.e.bleeding and/or broken skin)
9. Has known hypersensitivity towards any of the test products

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment sequence 1; First Coloplast Test product 1	Coloplast SenSura	The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods. Subjects are first allocated to test Coloplast Test product 1 and secondly test either: 1. Coloplast Test product 1 and thereafter Coloplast SenSura 2. Coloplast Sensura and thereafter Coloplast Test product 2
Treatment seqence 2; First Coloplast Test product 2.	Coloplast Test Product 1	The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods. Subjects are first allocated to test Coloplast Test product 2 and secondly test either: 1. Coloplast Test product 1 and thereafter Coloplast SenSura 2. Coloplast Sensura and thereafter Coloplast Test product 1
Treatment sequence 3, First Coloplast SenSura	Coloplast Test Product 1	The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods. Subjects are first allocated to test Coloplast SenSura and secondly test either: 1. Coloplast Test product 2 and thereafter Coloplast Test product 1 2. Coloplast Test product 1 and thereafter Coloplast Test product 2
Treatment sequence 1; First Coloplast Test product 1	Coloplast Test Product 2	The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods. Subjects are first allocated to test Coloplast Test product 1 and secondly test either: 1. Coloplast Test product 1 and thereafter Coloplast SenSura 2. Coloplast Sensura and thereafter Coloplast Test product 2
Treatment seqence 2; First Coloplast Test product 2.	Coloplast Test Product 2	The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods. Subjects are first allocated to test Coloplast Test product 2 and secondly test either: 1. Coloplast Test product 1 and thereafter Coloplast SenSura 2. Coloplast Sensura and thereafter Coloplast Test product 1
Treatment seqence 2; First Coloplast Test product 2.	Coloplast SenSura	The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods. Subjects are first allocated to test Coloplast Test product 2 and secondly test either: 1. Coloplast Test product 1 and thereafter Coloplast SenSura 2. Coloplast Sensura and thereafter Coloplast Test product 1
Treatment sequence 3, First Coloplast SenSura	Coloplast Test Product 2	The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods. Subjects are first allocated to test Coloplast SenSura and secondly test either: 1. Coloplast Test product 2 and thereafter Coloplast Test product 1 2. Coloplast Test product 1 and thereafter Coloplast Test product 2
Treatment sequence 1; First Coloplast Test product 1	Coloplast Test Product 1	The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods. Subjects are first allocated to test Coloplast Test product 1 and secondly test either: 1. Coloplast Test product 1 and thereafter Coloplast SenSura 2. Coloplast Sensura and thereafter Coloplast Test product 2
Treatment sequence 3, First Coloplast SenSura	Coloplast SenSura	The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods. Subjects are first allocated to test Coloplast SenSura and secondly test either: 1. Coloplast Test product 2 and thereafter Coloplast Test product 1 2. Coloplast Test product 1 and thereafter Coloplast Test product 2

Primary Outcome Measures

Name	Time	Method
Leakage	14 +- 1 days	The fraction of baseplates with No leakage/seeping under the baseplate was measured. Leakage/seeping under the baseplate was assessed after each baseplate change.

Trial Locations

Locations (4)

Holtedam 3; 🇩🇰 Humlebæk, Denmark

Sykepleierklinikken; 🇳🇴 Larvik, Norway

QPS Nederlands; 🇳🇱 Groningen, Netherlands

Synexus Limited; 🇬🇧 Chorley, Lancashire, United Kingdom