Investigation of Two New 1-piece Ostomy Products in People With an Ileostomy or Colostomy

Not Applicable

Completed

• Conditions: Colostomy; Ileostomy

• Registration Number: NCT02675634
• Lead Sponsor: Coloplast A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-29
• Study First Submitted QC: 2016-02-02
• Study First Posted: 2016-02-05
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Results First Submitted: 2017-08-04
• Results First Submitted QC: 2017-08-04
• Status Verified: 2017-09
• Results First Posted: 2017-09-05
• Last Update Submitted: 2017-09-14
• Last Update Posted: 2017-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Fit to Body	14 +/- 2 days	Subjects will evaluate the fit to body for each product by answering the question "how was the baseplates ability to fit the body contours in the area around the stoma?" The question is answered using an ordinal 5 point scale ranging from very poor to very good. The result shown below shows the fraction of subject who answered 'Good' or' Very Good' to the question.

Trial Locations

Locations (12)

Radiant Research; 🇺🇸 Tempe, Arizona, United States

Prism research center; 🇺🇸 Saint Paul, Minnesota, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

TFS; 🇩🇰 Søborg, Denmark

QPS Netherlands; 🇳🇱 Groningen, Netherlands

Synexus Midlands; 🇬🇧 Birmingham, United Kingdom

Pilgrim Hospital; 🇬🇧 Boston, United Kingdom

Illingworth Research Nurses; 🇬🇧 Cheshire, United Kingdom

Lincon Country hospital; 🇬🇧 Lincoln, United Kingdom

Aintree University Hospital NHS Foundation Trust; 🇬🇧 Liverpool, United Kingdom

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