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Completed

NCT Number: NCT01995357

The Influence of Baseplate Adhesive on the Degree of Leakage

The influence of the baseplate adhesive type, shape and application is investigated with regard to the degree of leakage.

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Key information

Conditions

Colostomy Stoma Ileostomy Stoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Coloplast A/S

Humlebæk, 3050, Denmark

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 signed letter of authority
  • Be at least 18 years of age and have full legal capacity
  • Have had their ileostomy/colostomy for at least 3 months
  • Have a stoma with a diameter between 15 and 36 mm
  • Be able to handle the products themselves
  • Be able to use a custom cut product
  • Normally experience faeces under the base plate at least 3 times during 2 weeks
  • Currently using SenSura 1-piece flat, open or closed bag, pre-cut or custom-cut or SenSura Mio 1-piece flat, closed bag, pre-cut or custom cut
  • Be willing to test the test products without using paste and/or ring
  • Be willing to use minimum 1 test product every second day, i.e. maximum 48 hours wear time per prod-uct
  • Be suitable for participation in the investigation
  • Be able to present a negative result of a pregnancy test - for women of childbearing age

Exclusion criteria

  • Are currently receiving or have within the past 2 months received radio- and/or chemotherapy
  • Are currently receiving or have within the past month received local or systemic steroid treatment in the peristomal area
  • 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/investigator representative)
  • Have a loop stoma
  • Have known hypersensitivity towards any of the test products (including adhesive remover)

Treatment and study plan

Coloplast Test A

Device

Coloplast Test A is a newly developed ostomy appliance

Coloplast Test B

Device

Coloplast Test B is a newly developed ostomy appliance.

Standard product

Device

Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation.

Primary outcomes

  1. Degree of Leakage

    Time frame: 10 (- 2 days)

    The primary endpoint was the degree of leakage under the baseplate, which was assessed using the three innermost rings of the 32-point leakage scale, corresponding to a total of 24 points (0 indicating no leakage and 24 indicating maximum leakage).

    Results are given separately for subjects with colostomy and ileostomy. In the ileostomy group there were no SenSura Mio participants in the standard care group.

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Official study title

The Influence of Base Plate Adhesive Type, Shape and Application on Degree of Leak-age - a Randomized Controlled Trial in Subjects With Ileostomy and Colostomy

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Nov 26, 2013
Registry last updated
Feb 3, 2015

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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