Assessment of New Enhanced Ostomy Device in Real-life Settings in Subjects Having a Stoma

Not Applicable

Completed

Conditions: Ileostomy - Stoma
Colostomy Stoma

Interventions: Device: Test Product A

Registration Number: NCT03770078

Lead Sponsor: Coloplast A/S

Brief Summary: The study investigates the performance of a new adhesive with regard to the skin condition

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 23

Inclusion Criteria

Have given written informed consent
Have an ileostomy or a colostomy with liquid* output (as their usual output)
Be at least 18 years of age and have full legal capacity
Have had their stoma for at least three months
Be able to use products with max cut size 45 mm
Have self-reported problems with leakage** (three times within 14 days)
Handle the Clinical App, test product and comparator product themselves
Use a flat SenSura® Mio or a flat SenSura® with standard adhesive as their current product
Minimum change of baseplate at least once every 3rd day
Are willing and suitable (determined by investigator/study nurse) to use the test product and comparator without using a paste/mouldable ring during the investigation
Are willing and suitable (determined by investigator/study nurse) to use a 1-piece product during the investigation

Exclusion Criteria

Are currently receiving or have within the past two 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)
Are currently receiving or have within the past month received topical steroid treatment in the peristomal skin area (e.g. lotion or spray) or systemic treatment* (e.g. injection or tablets).
Get a positive result of a pregnancy test for women of childbearing age/fertile (**clarified in section 6.3.2)
Are breast feeding
Are participating in other interventional clinical investigations or have previously participated in this investigation

Exception:

Participation in other Coloplast in-house clinical investigations is 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 (CP300) protocol.

Have known hypersensitivity towards any of the products used in the investigation

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study period	Test Product A	First the subjects will use the comparator (SenSura Mio) and then the test products (Test Product A)

Primary Outcome Measures

Name	Time	Method
Trans Epidermal Water Loss	Four weeks	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 a loss 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. Trans Epidermal Water Loss is reported in grams of water per square meter per hour (g/m\^2/h).

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (4): CCBR Vejle
🇩🇰
Vejle, Denmark
KTA Prim Stockholm
🇸🇪
Stockholm, Sweden
CCBR Aalborg
🇩🇰
Aalborg, Denmark
Coloplast
🇩🇰
Humlebæk, Denmark