Skip to main content
OpenTrials
Completed

NCT Number: NCT03154944

A Clinical Investigation Evaluating Three New 1-piece Ostomy Products

This investigation evaluates three new ostomy appliances and their impact on the peristomal skin.

Completed

Looking for future studies?

Notify Me

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, 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 in DK: signed a letter of authority
  • Be at least 18 years of age and have full legal capacity
  • Have had their ileostomy for at least 3 months
  • Have an ileostomy with a diameter between 10 and 55 mm
  • Be able to handle the Clinical App. and product themselves
  • Must be able to use custom cut product
  • Minimum change of product every second day
  • If current product is SenSura Mio - Be willing to use Maxi bag during investigation
  • Subject using Sensura or Sensura Mio flat 1 pc. open for at least two weeks before inclusion in the study.
  • Negative result of a pregnancy test for women of childbearing age (only DK)

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, e.g. below 15 mg methotrexate for rheumatoid arthritis)
  • Are currently receiving or have within the past month received topical steroid treatment in the peristomal skin area, e.g. lotion or spray. Systemic steroid treatment (e.g. injection, or tablet) are allowed.
  • Are pregnant or breastfeeding**
  • Are participating in other interventional clinical investigations or have previously participated in this investigation
  • Are currently suffering from peristomal skin problems i.e. bleeding and/or broken skin (assessed by the investigator)
  • Have known hypersensitivity towards any of the products used in the investigation

Treatment and study plan

Ostomy device 1

Device

This device consists of a known adhesive and a new top film

Ostomy device 2

Device

This device consists of a new adhesive and a known top film

Ostomy device 3

Device

This device consists of a known adhesive and a new top film

Primary outcomes

  1. Trans Epidermal Water Loss

    Time frame: 7 days

    The trans epidermal water loss is measured on the peristomal skin using a probe. The Tran epirdermal water loss is a maesure for the skins barrier function. There is always a loss of water from the skin due to natural evaporation. However, when the skin barrier is damaged the evaporation of water increases leading to a higher trans epidermal water loss. Thus, trans epidermal water loss is used to assess the damage to the skin. Measurements are in grams of water per square meter per hour (g/m^2/h).

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 16, 2017
Registry last updated
Mar 28, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.