Assessment of new enhanced ostomy devices in real-life settings in subjects having an ileostomy

Completed

• Conditions: Artificial opening for faeces; ostomy; 10017977

• Registration Number: NL-OMON44434
• Lead Sponsor: Coloplast A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

1. Have given written informed consent
2. Be at least 18 years of age and have full legal capacity
3. Have had their ileostomy for at least 3 months
4 .Must be able to use custom cut product
5. Can use a product with max cut size 45 mm
6. Self-reported problems with leakage (3 x within 14 days)
7. Can handle the Clinical App. and product themselves
8. Users get red skin after exposure to output (screening visit)

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 participating in other interventional clinical investigations or have previously participated in this investigation. Participation in other Coloplast in-house clinical investigations are accepted under the circumstances that the subject has paused the activities in the investigation and are otherwise complying with the inclusion and exclusion criteria of this (CP264) protocol.
4. Are currently suffering from peristomal skin problems i.e. bleeding and/or broken skin (assessed by the investigator)
5. Have known hypersensitivity towards any of the products used in the investigation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Trans epidermal water loss (TEWL) (30 min) in the inner circle around the<br /><br>stoma. Each TEWL measurement will be repeated three times.</p><br>