The aim of this investigation is to investigate the performance and safety of a new baseplate comprising a protective layer, which is expected to reduce peristomal skin complications induced by output.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
ileo- of colostomie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective is to investigate whether a new baseplate comprising of a
protective layer can reduce peristomal skin complications induced by output.
Secondary outcome
The secondary objective is to evaluate the psychometric properties of a new
clinical assessment tool for the peristomal skin condition.
Background summary
It is known that a stoma with liquid output can cause skin irritation around
the stoma. The non-CE marked investigational product is intended to support
collection of output from a stoma and to provide a barrier between peristomal
skin and stomal output and it is thought that it causes less skin irritation
than the products used so far.
Study objective
The aim of this investigation is to investigate the performance and safety of a
new baseplate comprising a protective layer, which is expected to reduce
peristomal skin complications induced by output.
Study design
This investigation is a randomised, controlled, open-label, comparative,
cross-over, multicentre investigation, with two test periods. In total 96
subjects will be included and randomised, and each subject will have three test
visits overseen by the Principal Investigator, or delegate. Each subject will
be enrolled for 2 × 42±3 days in total for the entire investigation, thus for a
maximum of 90 days. The subjects will test the Coloplast investigational
product and one of the comparator products in randomised order.
Intervention
Use of the investigational stoma product compared in a croos over design with
another usual stoma product.
Study burden and risks
The Coloplast investigational product comprises a protecting layer that should
help protect the skin from leakage induced skin damage, which could be
beneficial for the subjects. The outcome of this investigation will contribute
with important information for development of products for subjects with a
stoma.
Disadvantages during the investigation could be the extra workload related to
completion of questionnaires, visits at site and using the clinical app at each
change of product. The subjects are also asked to use a CEmarked competitor
product for the comparator test period that may not be their preferred product
on the market. The participating subjects will contribute with important
information for development of new stoma products, that may have less negative
impact on the peristomal skin. Due to the actions taken to mitigate the
abovementioned risks, the risks and disadvantages when participating in this
clinical investigation are estimated as low. The subject*s health will not
benefit directly from this investigation, but they may benefit from the use of
the new stoma product through less irritated peristomal skin and improved
quality of life in the future.
Holtedam 1-3
Humlebaek 3000
DK
Holtedam 1-3
Humlebaek 3000
DK
Listed location countries
Age
Inclusion criteria
1. Has given written consent to participate by signing the Informed Consent
Signature Form
2. Has an ileostomy or colostomy with liquid output (Definition of liquid
output: Six-Seven in the Bristol scale (Appendix 5 - Bristol scale)
3. Currently using a flat product
4. Be at least 18 years of age and have full legal capacity
5. Have had their stoma for at least three months (90 days)
6. Can use a product with a max cut size of 40 mm
7. Has experienced leakage* under the baseplate at least three times within the
last fourteen days. )*Leakage defined as output seeping under the baseplate
(Appendix 6 * Classification of leakage)
8. Has symptoms of peristomal skin complications or has peristomal skin
complications defined by at least one of the below
a) Has experienced symptoms of skin complications (itching, burning, pain)
within the last fourteen days
b) Has experienced red skin in the inner circle (within three cm from stoma
edge) within the last fourteen days
c) Has skin complication (assessed by Principal Investigator, or delegate) in
the inner circle (within three cm from stoma edge) of the peristomal area
9. Is able to handle the electronic diary (questionnaire/photo) themselves
10. Is able to handle (apply, remove, cut etc.) the product themselves
11. Is willing to not use barrier film or barrier cream during the
investigation
12. Is willing and suitable (determined by Principal Investigator, or delegate)
to use a flat custom cut one-piece open or a two-piece open product during the
investigation.
13. Is willing to change the product (1pc) or baseplate (2pc) at least every
fourth days.
Exclusion criteria
1. Is currently receiving or have within the past 60 days received radio-and/or
chemotherapy; low doses chemotherapy (assessed by Principal Investigator) is
allowed for indications other than cancer
2. Is currently receiving or have within the past month received topical
steroid treatment in the peristomal skin area, e.g. lotion or spray. Low dose
systemic steroid treatment (e.g. inhalation) assessed by the Principal
Investigator are allowed. Other systemic steroid treatment (e.g. injection, or
tablet) are not allowed.
3. Is breastfeeding
4. Is pregnant (based on pregnancy test - urine)
5. Has known hypersensitivity towards any of the products used in the
investigation
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL71653.068.19 |