Investigation of a new stoma product for people with a stoma

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 15

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective is to investigate whether a new baseplate comprising of a<br /><br>protective layer can reduce peristomal skin complications induced by output. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary objective is to evaluate the psychometric properties of a new<br /><br>clinical assessment tool for the peristomal skin condition. </p><br>