A Clinical Investigation Evaluating Three New 1-piece Ostomy Products

Not Applicable

Completed

• Conditions: Ileostomy - Stoma
• Interventions: Device: Ostomy device 3; Device: Ostomy device 2; Device: Ostomy device 1

• Registration Number: NCT03154944
• Lead Sponsor: Coloplast A/S

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-15
• Study First Submitted: 2017-05-15
• Study First Submitted QC: 2017-05-15
• Study First Posted: 2017-05-16
• Primary Completion: 2018-02-02
• Study Completion: 2018-02-02
• Results First Submitted: 2023-10-02
• Status Verified: 2025-03
• Results First Submitted QC: 2025-03-07
• Last Update Submitted: 2025-03-07
• Results First Posted: 2025-03-28
• Last Update Posted: 2025-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ostomy device 3	Ostomy device 3	In this arm the subjects test a new ostomy device consisting of a known adhesive and a new top film
Ostomy device 2	Ostomy device 2	In this arm the subjects test a new ostomy device consisting of a new adhesive and a known top film
Ostomy device 1	Ostomy device 1	In this arm the subjects test a new ostomy device consisting of a known adhesive and a new top film

Primary Outcome Measures

Name	Time	Method
Trans Epidermal Water Loss	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).

Trial Locations

Locations (1)

Coloplast A/S; 🇩🇰 Humlebaek, Denmark