A Clinical Investigation Examining the Performance and Handling of New 2-piece Ostomy Products in 28 People With an Ileostomy.

Ileostomy - Stoma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02064231
• Other study ID #: CP222
• Status: Completed
• Phase: N/A
• Start date: June 2012
• Est. completion date: August 2012

Study information

• Verified date: August 2020
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Had given written informed consent

2. Was at least 18 years of age

3. Was able to handle the appliances themselves or with help from a caregiver (e.g. spouse)

4. Had an ileostomy with a diameter between 15-45 mm

5. Have had an ileostomy for at least 3 months

6. Currently used a 2-piece flat appliance

Exclusion Criteria:

1. Used irrigation during the investigation (flush stoma with water)

2. Currently received or had within the past 2 months received radio- and/or chemotherapy.

3. Currently received or had within the past month received local or systemic steroid treatment in the peristomal area.

4. Was pregnant or breast feeding

5. Participated in other interventional studies that could interfere with this one or had previously participated in this investigation.

6. Had a baseplate wear time of more than three days

7. Suffered from peristomal skin problems that precluded participation in the investigation (assessed by the investigation nurse)

Related Conditions & MeSH terms

• Ileostomy - Stoma

Intervention

Device:
• Coloplast Test A
Coloplast Test A is a new ostomy appliance developed by Coloplast A/S
• Coloplast Test B
Coloplast Test B is a newly developed ostomy appliance developed by Coloplast A/S
• Own product
Own product is tested to get baseline results. Own product can be any 2-piece product that is commercially available. The manufactures can be Coloplast, Hollister, Convatec, Dansac, B. Braun and others.
• Coloplast Test C
Coloplast Test C is a new ostomy appliance developed by Coloplast A/S
• Coloplast Test D
Coloplast Test D is a new ostomy appliance developed by Coloplast A/S

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of Leakage	Degree of leakage is measured on a 24 point scale where 0 represents no leakage (best possible outcome) and 24 represents leakage on the whole plate (worst possible outcome).	14 days