Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
22 participants
INTERVENTIONAL
2012-04-30
2012-05-31
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
NONE
Study Groups
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Peristomal skin
The peel force used to remove two types of adhesive strips (Hydrocolloid strip and strata strip) from the Peristomal skin
Hydrocolloid strip
An adhesive strip made of hydrocolloid adhesive
Strata strip
An adhesive strip made of the Strata adhesive
Pre-stripped abdominal skin
The peel force used to remove two types of adhesive strips (Hydrocolloid strip and strata strip) from healthy abdominal skin
Hydrocolloid strip
An adhesive strip made of hydrocolloid adhesive
Strata strip
An adhesive strip made of the Strata adhesive
Interventions
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Hydrocolloid strip
An adhesive strip made of hydrocolloid adhesive
Strata strip
An adhesive strip made of the Strata adhesive
Eligibility Criteria
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Inclusion Criteria
2. Be in the age of 45 to 75 years of age both extremes included.
3. Have had a colostomy for at least 1 year.
4. Has a colostomy with a diameter up to (≤) 40 mm.
5. Have mental capacity to understand the study guidelines and questionnaires.
6. Be assessed by the investigator as having a peristomal and abdominal skin condition justifying entry into the investigation.
7. Are colostomists currently using a 1-piece and 2-piece flat ostomy appliance.
8. Have a BMI between 20-30 kg/m2.
9. Are willing to comply with investigation procedures.
Exclusion Criteria
2. Received radio- and/or chemotherapy within the last two months.
3. Currently using or have within the last 3 weeks used topical steroid products or other skin prep products.
on peristomal skin (injections and oral treatment are accepted).
4. Have dermatological problems.
5. Participating in other clinical studies or have previously participated in this test.
6. Be a daily user of a convex base-plate.
7. Are pregnant or breastfeeding.
8. Systemic elements that could affect skin histology (e.g. liver, kidney or immunological diseases).
45 Years
75 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, Denmark
Other Identifiers
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CP228
Identifier Type: -
Identifier Source: org_study_id
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