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

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.

Study Overview

• Status: Completed
• Conditions: Colostomy; Ileostomy
• Intervention / Treatment: Device: Coloplast Test Product; Device: Comparator (Hollister)

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Soeborg, Denmark, 2860
    • Trial Form Support ApS (TFS)
• Germany
  • Berlin, Germany, 12203
    • Charité - Universitätsmedizin Berlin, Klinik für Allgemein-, Gefäß- und Thoraxchirurgie
  • Hamburg, Germany, 22045
    • SIEWA Coloplast Homecare
• Netherlands
  • Groningen, Netherlands, 9713G12
    • QPS Netherlands
• Norway
  • Larvik, Norway, 3269
    • Sykepleierklinikken A/S, Larvik

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:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Coloplast Test Product then Comparator; The subject first tests the Coloplast Test Product and then tests the Comparator	Device: Coloplast Test Product; A new 2-piece ostomy appliance developed by Coloplast A/S; Device: Comparator (Hollister); Comparator is a Hollister FlexWear baseplate (ileostomy) or a Hollister SoftFlex baseplate (colostomy) both used with a Hollister open bag.
EXPERIMENTAL: Comparator then Coloplast Test Product; The subject first tests the Comparator and then tests the Coloplast Test Product.	Device: Coloplast Test Product; A new 2-piece ostomy appliance developed by Coloplast A/S; Device: Comparator (Hollister); Comparator is a Hollister FlexWear baseplate (ileostomy) or a Hollister SoftFlex baseplate (colostomy) both used with a Hollister open bag.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Coloplast A/S

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (ACTUAL): May 1, 2015
• Study Completion (ACTUAL): May 1, 2015

Study Registration Dates

• First Submitted: February 9, 2015
• First Submitted That Met QC Criteria: February 11, 2015
• First Posted (ESTIMATE): February 12, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): October 11, 2016
• Last Update Submitted That Met QC Criteria: August 18, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Ostomy
• Other Study ID Numbers: CP255