Clinical trial NCT02176954: The Influence of Adhesive Wafer Design on Fit to the Body
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ostomy - Ileostomy or Colostomy
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2014-06-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to investigate the influence of the adhesive wafer design on the products ability to fit to the body..


Eligibility criteria: Inclusion Criteria:

To participate in the study, it is mandatory that the subject fulfill all inclusions criteria:

* Have given written informed consent and signed letter of Authority
* Be at least 18 years of age and have full legal capacity
* Have had their ileostomy or colostomy for at least 3 months
* Have a stoma with a diameter between 15 and 43 mm
* Be able to handle the product themselves
* Be able to use a custom cut product
* Normally experience faeces under the adhesive wafer at least 3 times during 2 weeks
* Currently using a 1-piece flat product or a 1-piece soft convex product
* Be willing to test products with open bag size maxi
* Be willing to test Moderma Flex or Confidence® Natural, Drainable and the two test products A and B
* Be willing to use minimum 1 test product every second day, i.e. maximum 48 hours wear time per product
* Be suitable for participating in the investigation
* Be willing to take/have taken pictures of the stoma before, during and after application of product

Exclusion Criteria:

Subjects complying with the following criteria must be excluded from participation in the clinical investigation:

* Are currently receiving or have within the past 2 months received radio-and/or chemotherapy
* Are currently receiving or have within the past month received topical steroid treatment in the peri-stomal skin area or systemic steroid (tablet/injection) treatment
* Are pregnant or breastfeeding
* Are participating in other interventional clinical investigations or have previously participated in this investigation
* Use irrigation during the investigation (flush the intestines with water)
* Are currently suffering from peri-stomal skin problems i.e. bleeding and/or broken skin (assessed by the study nurse)
* Have a loop stoma
* Have known hypersensitivity towards any of the test products

Primary outcomes:
measure: Fit to body
timeFrame: 14 +/- 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: QPS Netherlands
city: Berkshire
country: United Kingdom
facility: Synexus Thames Valley
city: Birmingham
country: United Kingdom
facility: Synexus Midlands
city: Cardiff
country: United Kingdom
facility: Synexus Wales
city: Glasgow
country: United Kingdom
facility: Synexus Scotland
city: Gloucestershire
country: United Kingdom
facility: Cheltenham General Hospital
city: Lancashire
country: United Kingdom
facility: Synesxus Lancashire
city: Liverpool
country: United Kingdom
facility: Synexus Merseyside
city: Manchester
country: United Kingdom
facility: Synexus Manchester
city: Northumberland
country: United Kingdom
facility: Synexus North East
Study officials:
affiliation: QPS Netherlands
name: Khalid Abd-Elaziz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Synexus North East, United Kingdom
name: Susanne Eyre, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cheltenham General Hospital, United Kingdom
name: Gillian Hopkins
role: PRINCIPAL_INVESTIGATOR
References: