Investigation of the Performance and Safety of New 1-piece Open Ostomy Appliances Compared to Standard Care

Ileostomy - Stoma Clinical Trial

Official title:

An Open-labelled, Randomized, Controlled, Comparative, Single Country (Denmark), Explorative, Cross-over Study Investigating the Performance and Safety of New 1-piece Open Ostomy Appliances Compared to Standard Care 1-piece Open Ostomy Appliances in 25 Subjects With Ileostomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01957384
• Other study ID #: CP221
• Status: Completed
• Phase: N/A
• First received: February 22, 2013
• Last updated: February 26, 2014
• Start date: February 2012
• Est. completion date: May 2012

Study information

• Verified date: February 2014
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

To assess the functionality and safety of the test products and also assess the products' ability to collect stool without interfering with the stoma. The degree of leakage using the product will also be measured

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have given written informed consent

• Be at least 18 years of age and have full legal capacity

• Be able to handle the bags themselves or with help from caregiver

• Have an ileostomy with a diameter between 15 and 45 mm

• Have had their ostomy for at least three months

• Currently use a 1-piece flat standard care product with open bag

• Negative result of a pregnancy test for women of childbearing age

• Custom-cut product user

• Be suitable for participation in the investigation

Exclusion Criteria:

• Use irrigation during the study (flush the stoma with water)

• Currently receiving or have within the past 2 months received radio- and/or chemotherapy

• Currently receiving or have within the past month received local or systemic steroid treatment in the peristomal area

• Are pregnant or breastfeeding

• Participating in other interventional clinical investigations or have previously participated in this investigation

• Max three days wear time

• Suffer from peristomal skin problems that preclude participation in the investigation (assessed by the investigation nurse)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Ileostomy - Stoma

Intervention

Device:
• Coloplast Test product 1
Coloplast Test product 1 is a new ostomy appliance developed by Coloplast.
• Coloplast Test product 2
Coloplast Test product 2 is a new ostmoy appliance developed by Coloplast A/S
• Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)
Standard Care was the subject usual ostomy appliance and had to be one of the following: Coloplast: SenSura, 1-piece open bag without inspection window, size midi and maxi, custom-cut, Dansac: Nova 1 & Nova Life, 1-piece open bag, size midi and maxi, custom-cut baseplate Hollister: Moderma Flex, 1-piece open, size midi and maxi, custom-cut baseplate ConvaTec: Esteem, 1-piece open bag, size midi and maxi, custom-cut baseplate B. Braun: Flexima Active & Softima, 1-piece open bag, size midi and maxi, custom-cut baseplate

Locations

Country	Name	City	State
Denmark	Coloplast A/S	Humlebæk

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of Leakage	The degree of leakage was measured on a 24-point scale 0 (best possible outcome) to 24 (worst possible outcome) developed by Coloplast A/S	Up to 14 days per test product	No