Assessment of New Ostomy Devices in Subjects Having an Ileostomy

Not Applicable

Completed

• Conditions: Ileostomy - Stoma
• Interventions: Device: SenSura Mio; Device: Coloplast Ostomy device 1; Device: Coloplast Ostomy device; Device: Coloplast Ostomy device 3

• Registration Number: NCT03427203
• Lead Sponsor: Coloplast A/S

Brief Summary

The study investigates the performance of three new adhesives with regard to leakage and the skin condition.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-09
• Study First Submitted: 2018-01-29
• Study First Submitted QC: 2018-02-02
• Study First Posted: 2018-02-09
• Primary Completion: 2018-04-06
• Study Completion: 2018-04-06
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-04
• Last Update Posted: 2018-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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. 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. Get a 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 4.1. Exception: 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.
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: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm 1	Coloplast Ostomy device 1	The subjects test the products in the following order SenSura Mio (comparator) Coloplast Ostomy device 1 Coloplast Ostomy device 2 Coloplast Ostomy device 3
Arm 2	Coloplast Ostomy device	The subjects test the products in the following order SenSura Mio (comparator) Coloplast Ostomy device 1 Coloplast Ostomy device 3 Coloplast Ostomy device2
Arm 1	Coloplast Ostomy device	The subjects test the products in the following order SenSura Mio (comparator) Coloplast Ostomy device 1 Coloplast Ostomy device 2 Coloplast Ostomy device 3
Arm 1	Coloplast Ostomy device 3	The subjects test the products in the following order SenSura Mio (comparator) Coloplast Ostomy device 1 Coloplast Ostomy device 2 Coloplast Ostomy device 3
Arm 2	SenSura Mio	The subjects test the products in the following order SenSura Mio (comparator) Coloplast Ostomy device 1 Coloplast Ostomy device 3 Coloplast Ostomy device2
Arm 2	Coloplast Ostomy device 1	The subjects test the products in the following order SenSura Mio (comparator) Coloplast Ostomy device 1 Coloplast Ostomy device 3 Coloplast Ostomy device2
Arm 1	SenSura Mio	The subjects test the products in the following order SenSura Mio (comparator) Coloplast Ostomy device 1 Coloplast Ostomy device 2 Coloplast Ostomy device 3
Arm 2	Coloplast Ostomy device 3	The subjects test the products in the following order SenSura Mio (comparator) Coloplast Ostomy device 1 Coloplast Ostomy device 3 Coloplast Ostomy device2

Primary Outcome Measures

Name	Time	Method
Trans epidermal water loss	14 days	Trans epidermal water loss is an objective skin measurement that is measures the evaporation of water on the skin surface using a probe (DermaLab).The trans epidermal water loss is a measure for the skins barrier function. There is always aloss of water from the skin due to evaporation. When the skin barrier is damaged this evaporation of water increases. Thus, transepidermal water loss can be used to assess skin damage

Trial Locations

Locations (3)

Coloplast A/S; 🇩🇰 Humlebæk, Denmark

CCBR Vejle; 🇩🇰 Vejle, Denmark

QPS Netherlands; 🇳🇱 Groningen, Netherlands