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OpenTrials
Completed

NCT Number: NCT01957384

Investigation of the Performance and Safety of New 1-piece Open Ostomy Appliances Compared to Standard Care

To assess the functionality and safety of the test products and also assess the products' ability to collect stool without interfering with the stoma. The degree of leakage using the product will also be measured

Completed

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Key information

Conditions

Ileostomy - Stoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Coloplast A/S

Humlebæk, 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
  • Be at least 18 years of age and have full legal capacity
  • Be able to handle the bags themselves or with help from caregiver
  • Have an ileostomy with a diameter between 15 and 45 mm
  • Have had their ostomy for at least three months
  • Currently use a 1-piece flat standard care product with open bag
  • Negative result of a pregnancy test for women of childbearing age
  • Custom-cut product user
  • Be suitable for participation in the investigation

Exclusion criteria

  • Use irrigation during the study (flush the stoma with water)
  • Currently receiving or have within the past 2 months received radio- and/or chemotherapy
  • Currently receiving or have within the past month received local or systemic steroid treatment in the peristomal area
  • Are pregnant or breastfeeding
  • Participating in other interventional clinical investigations or have previously participated in this investigation
  • Max three days wear time
  • Suffer from peristomal skin problems that preclude participation in the investigation (assessed by the investigation nurse)

Treatment and study plan

Coloplast Test product 1

Device

Coloplast Test product 1 is a new ostomy appliance developed by Coloplast.

Coloplast Test product 2

Device

Coloplast Test product 2 is a new ostmoy appliance developed by Coloplast A/S

Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)

Device

Standard Care was the subject usual ostomy appliance and had to be one of the following:

  • Coloplast: SenSura, 1-piece open bag without inspection window, size midi and maxi, custom-cut,
  • Dansac: Nova 1 & Nova Life, 1-piece open bag, size midi and maxi, custom-cut baseplate
  • Hollister: Moderma Flex, 1-piece open, size midi and maxi, custom-cut baseplate
  • ConvaTec: Esteem, 1-piece open bag, size midi and maxi, custom-cut baseplate
  • B. Braun: Flexima Active & Softima, 1-piece open bag, size midi and maxi, custom-cut baseplate

Primary outcomes

  1. Degree of Leakage

    Time frame: Up to 14 days per test product

    The degree of leakage was measured on a 24-point scale 0 (best possible outcome) to 24 (worst possible outcome) developed by Coloplast A/S

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Official study title

An Open-labelled, Randomized, Controlled, Comparative, Single Country (Denmark), Explorative, Cross-over Study Investigating the Performance and Safety of New 1-piece Open Ostomy Appliances Compared to Standard Care 1-piece Open Ostomy Appliances in 25 Subjects With Ileostomy

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Oct 8, 2013
Registry last updated
Mar 27, 2014

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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