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

Investigating the Safety and Performance of Two New 1-piece Ostomy Products in 180 Subjects With Ileostomy

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

Study Overview

• Status: Completed
• Conditions: Ileostomy - Stoma
• Intervention / Treatment: Device: Coloplast Test Product 1; Device: Coloplast Test Product 2; Device: Coloplast SenSura

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 183
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Humlebæk, Denmark, 3050
    • Holtedam 3
• Netherlands
  • Groningen, Netherlands, 9713
    • QPS Nederlands
• Norway
  • Larvik, Norway, 3269
    • Sykepleierklinikken
• United Kingdom
  • Lancashire
    • Chorley, Lancashire, United Kingdom, PR71NY
      • Synexus Limited

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment sequence 1; First 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: Coloplast Test product 1 and thereafter Coloplast SenSura; Coloplast Sensura and thereafter Coloplast Test product 2	Device: Coloplast Test Product 1; Coloplast Test product 1 is a newly developed 1-piece ostomy appliance; Device: Coloplast Test Product 2; Coloplast Test product 2 is a newly developed 1-piece ostomy appliance; Device: Coloplast SenSura; SenSura 1-piece is the commercial available CE-marked SenSura 1-piece from Coloplast A/S.; Other Names: SenSura 1-piece
Experimental: Treatment seqence 2; First 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: Coloplast Test product 1 and thereafter Coloplast SenSura; Coloplast Sensura and thereafter Coloplast Test product 1	Device: Coloplast Test Product 1; Coloplast Test product 1 is a newly developed 1-piece ostomy appliance; Device: Coloplast Test Product 2; Coloplast Test product 2 is a newly developed 1-piece ostomy appliance; Device: Coloplast SenSura; SenSura 1-piece is the commercial available CE-marked SenSura 1-piece from Coloplast A/S.; Other Names: SenSura 1-piece
Experimental: Treatment sequence 3, First 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: Coloplast Test product 2 and thereafter Coloplast Test product 1; Coloplast Test product 1 and thereafter Coloplast Test product 2	Device: Coloplast Test Product 1; Coloplast Test product 1 is a newly developed 1-piece ostomy appliance; Device: Coloplast Test Product 2; Coloplast Test product 2 is a newly developed 1-piece ostomy appliance; Device: Coloplast SenSura; SenSura 1-piece is the commercial available CE-marked SenSura 1-piece from Coloplast A/S.; Other Names: SenSura 1-piece

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Coloplast A/S
• Investigators: Principal Investigator: Birte P Jakobsen, MD, Coloplast A/S

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: August 6, 2013
• First Submitted That Met QC Criteria: October 1, 2013
• First Posted (Estimate): October 8, 2013

Study Record Updates

• Last Update Posted (Actual): September 10, 2020
• Last Update Submitted That Met QC Criteria: August 26, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: CP242