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Completed

NCT Number: NCT01799239

Safety and Performance of Newly Developed 1-piece Ostomy Product Compared With SenSura

The aim of the current investigation is to evaluate the combination of an adhesive with a soft top film.

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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

Skövde Hospital

Skövde, 541 85, Sweden

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
  • Have an ileostomy with a diameter between 15 and 55 mm
  • Have had their ileostomy for at least 3 months
  • Currently use a 1-piece flat ostomy appliance with open bag
  • Use minimum 1 product every second day, i.e. maximum 2 days wear time
  • Be suitable for participation in the study and for using a standard adhesive, flat base plate
  • Must be able and willing to use custom cut products
  • Accept to test two 1-piece products within the study period

Exclusion criteria

  • Use irrigation during the study period (flush the intestines with water)
  • Currently receiving or have within the past 2 months received chemotherapy or radiation therapy
  • Currently receiving or have within the past month received systematic steroid or local treatment in the peristomal area
  • Are pregnant or breastfeeding
  • Participating in other interventional clinical investigations or have previously participated in this investigation
  • Currently using a ostomy belt
  • Currently using extended wear product
  • Have a loop ileostomy
  • Known hypersensitivity towards any of the test products
  • Suffering from severe peristomal skin problems prior to participation in the investigation (assessed by the study nurse)

Treatment and study plan

Test Product

Device

The test product consists of an adhesive with a new top film

SenSura

Device

SenSura is the CE-marked and commercially available comparator product

Primary outcomes

  1. Leakage (Percentage of All Baseplates With Leakage)

    Time frame: After each baseplate change over a period, of 7 days

    leakage is measured using a 4-point leakage scale developed by Coloplast A/S. At every baseplate change the subjects had to look at the skin facing side of the baseplate and access which of the four scenarios described below provided an accurate description of the baseplate.

    The subjects tick of one of the four possible answers:

    • No leakage
    • Starting to leak (leakage under the baseplate)
    • Leakage (seepage of faeces resulting in leakage on clothes)
    • Sudden leakage (the baseplate pops off resulting in sudden leakage under the baseplate and outside the baseplate)

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Official study title

Investigating the Safety and Performance of Newly Developed 1-piece Ostomy Product Concept Compared With SenSura 1-piece in Subjects With an Ileostomy

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Feb 26, 2013
Registry last updated
Sep 30, 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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