A Clinical Investigation Evaluating Three New 1-piece Ostomy Products

June 4, 2018 updated by: Coloplast A/S
This investigation evaluates three new ostomy appliances and their impact on the peristomal skin.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Humlebaek, Denmark, 3050
        • Coloplast A/S

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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)
  2. 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.
  3. Are pregnant or breastfeeding**
  4. Are participating in other interventional clinical investigations or have previously participated in this investigation
  5. Are currently suffering from peristomal skin problems i.e. bleeding and/or broken skin (assessed by the investigator)
  6. Have known hypersensitivity towards any of the products used in the investigation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ostomy device 1
In this arm the subjects test a new ostomy device consisting of a known adhesive and a new top film
Device: Ostomy device 1
This device consists of a known adhesive and a new top film
Experimental: Ostomy device 2
In this arm the subjects test a new ostomy device consisting of a new adhesive and a known top film
Device: Ostomy device 2
This device consists of a new adhesive and a known top film
Experimental: Ostomy device 3
In this arm the subjects test a new ostomy device consisting of a known adhesive and a new top film
Device: Ostomy device 3
This device consists of a known adhesive and a new top film

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Coloplast A/S

Investigators

  • Principal Investigator: Birte P Jakosen, MD, Medial director

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2017

Primary Completion (Actual)

February 2, 2018

Study Completion (Actual)

February 2, 2018

Study Registration Dates

First Submitted

May 15, 2017

First Submitted That Met QC Criteria

May 15, 2017

First Posted (Actual)

May 16, 2017

Study Record Updates

Last Update Posted (Actual)

June 6, 2018

Last Update Submitted That Met QC Criteria

June 4, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • CP275

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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