Investigation of a New 2-piece Ostomy Product in People With an Ileostomy or Colostomy

Colostomy Clinical Trial

Official title:

Investigation of a New 2-piece Ostomy Product in People With an Ileostomy or Colostomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02362360
• Other study ID #: CP255
• Status: Completed
• Phase: N/A
• First received: February 9, 2015
• Last updated: August 5, 2015
• Start date: February 2015
• Est. completion date: May 2015

Study information

• Verified date: August 2015
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines AuthorityGermany: Federal Institute for Drugs and Medical DevicesNorway: Directorate of HealthNetherlands: Dutch Health Care Inspectorate
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the influence of a new ostomy product on the peristomal fit for people with an ileo- or colostomy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have given written informed consent and in DK: signed a letter of authority

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

• Have had their ileostomy or colostomy for at least 3 months

• Able to use a baseplate size 15 to 40 mm

• Be able to handle the product themselves

• Normally experience faeces under the baseplate at least 3 times during 2 weeks

• Currently using a 2-piece flat product with mechanical coupling

• Willing to test both the Coloplast test product and the comparator product

• Willing to use an open bag size maxi during the investigation

• Willing to use Coloplast test product and comparator products without initial use of accessories (except tube paste / belt)

• Willing to use at least 1 baseplate every 3rd day during the investigation

• Is able to use a custom cut product

• Be suitable for participating in the investigation

Exclusion Criteria:

• Are currently receiving or have within the past 2 months received radio-and/or chemotherapy (low doses chemotherapy are allowed for other indications than cancer)

• Are currently receiving or have within the past month received topical steroid treatment in the peristomal skin area (lotion or spray). Systemic steroid (tablet/injection) treatment are allowed

• Are pregnant or breastfeeding

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

• Use irrigation during the investigation (flush the intestines with water)

• Are currently suffering from peristomal skin problems i.e. bleeding and/or broken skin (assessed by the investigator)

• Have a loop ostomy

• Have known hypersensitivity towards any of the products used in the investigation

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Colostomy
• Ileostomy

Intervention

Device:
• Coloplast Test Product
A new 2-piece ostomy appliance developed by Coloplast A/S
• Comparator (Hollister)
Comparator is a Hollister FlexWear baseplate (ileostomy) or a Hollister SoftFlex baseplate (colostomy) both used with a Hollister open bag.

Locations

Country	Name	City	State
Denmark	Trial Form Support ApS (TFS)	Soeborg
Germany	Charité - Universitätsmedizin Berlin, Klinik für Allgemein-, Gefäß- und Thoraxchirurgie	Berlin
Germany	SIEWA Coloplast Homecare	Hamburg
Netherlands	QPS Netherlands	Groningen
Norway	Sykepleierklinikken A/S, Larvik	Larvik

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Countries where clinical trial is conducted

Denmark,  Germany,  Netherlands,  Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fit to the peristomal area, measured by a 5-point scale ranging from "very poor" to "very good".	Subjects will evaluate the fit to body for each product by answering the question "How was the baseplates ability to fit to the body contours in the area around the stoma?". The question is answered with a 5-point scale ranging from "very poor" to "very good".	21 +/- 3 days	No