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Completed

NCT Number: NCT02362360

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.

Completed

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Key information

Conditions

Ileostomy Colostomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Trial Form Support ApS (TFS), Soeborg, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coloplast test product

Device

A new 2-piece ostomy appliance developed by Coloplast A/S

Comparator (Hollister)

Device

Comparator is a Hollister FlexWear baseplate (ileostomy) or a Hollister SoftFlex baseplate (colostomy) both used with a Hollister open bag.

Primary outcomes

  1. Fit to the Peristomal Area, Measured by a 5-point Scale Ranging From "Very Poor" to "Very Good".

    Time frame: 21 +/- 3 days

    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".

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Feb 12, 2015
Registry last updated
Oct 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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