Clinical trial NCT02675634: Investigation of Two New 1-piece Ostomy Products in People With an Ileostomy or Colostomy
Official title: Investigation of Two New 1-piece Ostomy Products in People With an Ileostomy or Colostomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ileostomy
Colostomy
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2016-02-05
Enrollment: 55
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: This clinical investigation is intended to explore the performance and safety of two newly developed ostomy products with regard to the products fit to body properties.


Eligibility criteria: Inclusion Criteria:

1. Have given written informed consent and in DK: signed a letter of authority 2. Are at least 18 years of age and have full legal capacity 3. Have had their ileostomy or colostomy for at least 3 months 4. Are able to use a baseplate cut-max 15 to 40 mm 5. Are able to handle the product themselves 6. Currently using a 1-piece flat product 8. Willing to use an open bag size maxi during the investigation 9. Are able to use a custom cut (custom fit) product 10. Are suitable for participating in the investigation - this means that the subjects must be able to follow all elements of the study procedures.

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
5. Use irrigation during the investigation (flush the intestines with water, this is mostly for people with a colostomy)
6. Are currently suffering from peristomal skin problems i.e. bleeding and/or broken skin (assessed by the investigator)
7. Have a loop ostomy (also called double barrel ostomy)
8. Have known hypersensitivity towards any of the products used in the investigation

   * In DK: women in the child-bearing age will be ask to produce a negative pregnancy test and to sign a form ensuring the use of safe contraception during the investigation.

Primary outcomes:
measure: Fit to Body
timeFrame: 14 +/- 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Radiant Research
state: Arizona
city: Saint Paul
country: United States
facility: Prism research center
state: Minnesota
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Søborg
country: Denmark
facility: TFS
city: Groningen
country: Netherlands
facility: QPS Netherlands
city: Birmingham
country: United Kingdom
facility: Synexus Midlands
city: Boston
country: United Kingdom
facility: Pilgrim Hospital
city: Cheshire
country: United Kingdom
facility: Illingworth Research Nurses
city: Lincoln
country: United Kingdom
facility: Lincon Country hospital
city: Liverpool
country: United Kingdom
facility: Aintree University Hospital NHS Foundation Trust
city: Northamptonshire
country: United Kingdom
facility: Kettering General hospital
city: Northumberland
country: United Kingdom
facility: Synexus Hexam
Study officials:
affiliation: Head of Clinical Operation
name: Camilla F Vibjerg
role: STUDY_CHAIR
References: