Assessment of New Ostomy Devices in Subjects Having an Ileostomy

Ileostomy - Stoma Clinical Trial

Official title:

Assessment of New Enhanced Ostomy Devices in Real-life Set-tings in Subjects Having an Ileostomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03427203
• Other study ID #: CP264
• Status: Completed
• Phase: N/A
• Start date: January 9, 2018
• Est. completion date: April 6, 2018

Study information

• Verified date: June 2018
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: April 6, 2018
• Est. primary completion date: April 6, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ileostomy - Stoma

Intervention

Device:
• SenSura Mio
SenSura Mio is a marked ostomy device which is used as the comparator in this study
• Coloplast Ostomy device 1
Coloplast Ostomy device 1 a newly developed ostomy device
• Coloplast Ostomy device
Coloplast Ostomy device 2 a newly developed ostomy device
• Coloplast Ostomy device 3
Coloplast Ostomy device 3 a newly developed ostomy device

Locations

Country	Name	City	State
Denmark	Coloplast A/S	Humlebæk
Denmark	CCBR Vejle	Vejle
Netherlands	QPS Netherlands	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Countries where clinical trial is conducted

Denmark,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trans epidermal water loss	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	14 days