Safety and Performance of New 1-piece Ostomy Product

Not Applicable

Completed

• Conditions: Stoma Ileostomy
• Interventions: Device: Coloplast Adhesive baseplate A; Device: Coloplast Adhesive baseplate B; Device: Coloplast Adhesive baseplate C; Device: SenSura 1-Piece

• Registration Number: NCT01800916
• Lead Sponsor: Coloplast A/S

Brief Summary

The aim of the the current investigation is to develop new soft and more flexible 1-piece ostomy products.

Detailed Description

The present investigation aims at testing the degree of leakage with the new flexible 1-piece ostomy products as well as other performance and safety parameters.

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-22
• Study First Submitted QC: 2013-02-27
• Study First Posted: 2013-02-28
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Results First Submitted: 2014-04-27
• Results First Submitted QC: 2014-04-27
• Results First Posted: 2014-05-30
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-17
• Last Update Posted: 2017-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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 bags themselves.
4. Have an ileostomy with a diameter between 15 and 40 mm.
5. Have had their ostomy for at least three months.
6. Currently use a 1-piece flat ostomy appliance with open bag.
7. Use minimum 1 ostomy appliance every second day.
8. Be suitable for participation in the investigation and for using standard adhesive, flat base plate.
9. Must be able to use a custom cut ostomy appliance.
10. Accept to test three 1-piece ostomy appliances in the investigation.
11. Negative result of a pregnancy test for women of childbearing age (only DK).

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 months 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. Currently using ostomy belt.
7. Currently using extended wear product.
8. Known hypersensitivity towards any of the test products
9. 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 Adhesive baseplate B	The subjects randomised to Treatment sequence 1 are going to test 1. Coloplast Adhesive baseplate A (A) 2. Coloplast Adhesive baseplate B (B) 3. SenSura 1-piece (S) The subjects test the three test products in a randomised order: ABS; BSA; SAB
Treatment sequence 2	SenSura 1-Piece	The subjects randomised to Treatment sequence 2 are going to test 1. Coloplast Adhesive baseplate B (B) 2. Coloplast Adhesive baseplate C (C) 3. SenSura 1-piece (S) The subjects test the three test products in a randomised order: CBS; BSC; SCB
Treatment sequence 2	Coloplast Adhesive baseplate B	The subjects randomised to Treatment sequence 2 are going to test 1. Coloplast Adhesive baseplate B (B) 2. Coloplast Adhesive baseplate C (C) 3. SenSura 1-piece (S) The subjects test the three test products in a randomised order: CBS; BSC; SCB
Treatment sequence 3	SenSura 1-Piece	The subjects randomised to Treatment sequence 3 are going to test 1. Coloplast Adhesive baseplate A (A) 2. Coloplast Adhesive baseplate B (C) 3. SenSura 1-piece (S) The subjects test the three test products in a randomised order: ACS; CSA; SAC
Treatment sequence 3	Coloplast Adhesive baseplate A	The subjects randomised to Treatment sequence 3 are going to test 1. Coloplast Adhesive baseplate A (A) 2. Coloplast Adhesive baseplate B (C) 3. SenSura 1-piece (S) The subjects test the three test products in a randomised order: ACS; CSA; SAC
Treatment sequence 1	Coloplast Adhesive baseplate A	The subjects randomised to Treatment sequence 1 are going to test 1. Coloplast Adhesive baseplate A (A) 2. Coloplast Adhesive baseplate B (B) 3. SenSura 1-piece (S) The subjects test the three test products in a randomised order: ABS; BSA; SAB
Treatment sequence 1	SenSura 1-Piece	The subjects randomised to Treatment sequence 1 are going to test 1. Coloplast Adhesive baseplate A (A) 2. Coloplast Adhesive baseplate B (B) 3. SenSura 1-piece (S) The subjects test the three test products in a randomised order: ABS; BSA; SAB
Treatment sequence 2	Coloplast Adhesive baseplate C	The subjects randomised to Treatment sequence 2 are going to test 1. Coloplast Adhesive baseplate B (B) 2. Coloplast Adhesive baseplate C (C) 3. SenSura 1-piece (S) The subjects test the three test products in a randomised order: CBS; BSC; SCB
Treatment sequence 3	Coloplast Adhesive baseplate C	The subjects randomised to Treatment sequence 3 are going to test 1. Coloplast Adhesive baseplate A (A) 2. Coloplast Adhesive baseplate B (C) 3. SenSura 1-piece (S) The subjects test the three test products in a randomised order: ACS; CSA; SAC

Primary Outcome Measures

Name	Time	Method
Degree of Leakage	one week	The degree of leakage is measured using a 4-point leakage scale developed by Coloplast A/S at every baseplate change.; The subjects had to tick off one of the following choices: 1. No leakage; 2. Starting to leak; 3. Leakage; 4. Sudden Leakage

Trial Locations

Locations (1)

Holtedam 3; 🇩🇰 Humlebæk, Denmark