A Clinical Pilot Study of Newly Developed Ostomy Tapes and How They Adhere to the Skin
NCT ID: NCT04544566
Last Updated: 2021-05-06
Study Results
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View full resultsBasic Information
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COMPLETED
NA
12 participants
INTERVENTIONAL
2020-07-07
2020-08-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
NONE
Study Groups
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Test product A new adhesive material
The adhesives in the ostomy tapes are developed to make the tape seal to the skin and thereby minimise the risk of leakage episodes. At the same time, the tape should be easy to remove without affecting the skin.
Test product A
one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Test product B
one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Comparator
Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin
Test product B new adhesion material
The adhesives in the ostomy tapes are developed to make the tape seal to the skin and thereby minimise the risk of leakage episodes. At the same time, the tape should be easy to remove without affecting the skin.
Test product A
one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Test product B
one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Comparator
Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin
Comparator
The comparator product is Brava Elastic tape which is already on the market and will be used within the in-tended use in this clinical investigation.
Test product A
one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Test product B
one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Comparator
Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin
Interventions
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Test product A
one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Test product B
one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Comparator
Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin
Eligibility Criteria
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Inclusion Criteria
* Be at least 18 years of age and have full legal capacity
* Have had a stoma for more than ½ year
* Have intact skin on the area used in the study (Assessed by investigator, see Appendix 1).
* Willing to change baseplate every second day or less frequent
* Willing to avoid using Concave baseplate during the study.
* Willing to avoid the use of barrier creams or similar that affect the skin/adhesive interface under the tape.
Exclusion Criteria
* Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet(injection) treatment
* Is pregnant or breastfeeding
* Having dermatological problems in the peristomal area (assessed by investigator)
18 Years
ALL
No
Sponsors
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Coloplast A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Tonny Karlsmark, MD
Role: PRINCIPAL_INVESTIGATOR
Bispebjerg hospital, Dermato-Venerologisk afdeling.
Locations
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Bispebjerg hospital
Copenhagen, Copenhagen NV, Denmark
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CP319
Identifier Type: -
Identifier Source: org_study_id
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