Status:
COMPLETED
Human Skin Test Model in Colostomists
Lead Sponsor:
Coloplast A/S
Conditions:
Colostomy Stoma
Eligibility:
All Genders
45-75 years
Phase:
NA
Brief Summary
The aim of the study is to investigate the correlation in peel force when peeling off a standard hydrocolloid adhesive strip and standard strata adhesive strip from peristomal skin compared to pre-str...
Eligibility Criteria
Inclusion
- Have given written informed consent.
- Be in the age of 45 to 75 years of age both extremes included.
- Have had a colostomy for at least 1 year.
- Has a colostomy with a diameter up to (≤) 40 mm.
- Have mental capacity to understand the study guidelines and questionnaires.
- Be assessed by the investigator as having a peristomal and abdominal skin condition justifying entry into the investigation.
- Are colostomists currently using a 1-piece and 2-piece flat ostomy appliance.
- Have a BMI between 20-30 kg/m2.
- Are willing to comply with investigation procedures.
Exclusion
- Currently suffering from peristomal skin problems (i.e. bleeding or broken skin).
- Received radio- and/or chemotherapy within the last two months.
- 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).
- Have dermatological problems.
- Participating in other clinical studies or have previously participated in this test.
- Be a daily user of a convex base-plate.
- Are pregnant or breastfeeding.
- Systemic elements that could affect skin histology (e.g. liver, kidney or immunological diseases).
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01918085
Start Date
April 1 2012
End Date
May 1 2012
Last Update
March 12 2014
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