Status:
COMPLETED
Controlled Randomized Study With Athena Base Plate Versus SenSura Base Plate on Perspiring Skin
Lead Sponsor:
Coloplast A/S
Collaborating Sponsors:
Lægernes Test Center A/S
Conditions:
Healthy
Eligibility:
MALE
50-70 years
Phase:
NA
Brief Summary
Aim The aim of the Athena project is to develop an ostomy product that is softer and more flexible in order to improve the comfort for people with a stoma. The present investigation aims at testing ...
Detailed Description
The aim of the Athena project is to develop an ostomy product, for people with a colostomy, with better comfort than other normal ostomy products. This has been attempted through development of a soft...
Eligibility Criteria
Inclusion
- Group A: Men without a stoma in the age of 50-70 years Group B: Men with a stoma
- Inclusion criteria:
- To be included in the investigation, the subjects in Group A must comply with the following selection criteria:
- Have signed informed consent and letter of attorney
- Be a man in the age of 50-70 years
- Is capable of understanding the experiment
- Have a BMI (body mass index) between 20-30 kg/m2
- Is willing to test the adhesives from the two Coloplast products, Athena and SenSura
- Is evaluated as suitable for inclusion according to cardiovascular test and fitness test performed at the screening
- To be included in the investigation, the subjects in Group B must comply with the following selection criteria:
- Have signed informed consent and letter of attorney
- Be a man of at least 18 years of age
- Have a colostomy with a max width of 45 mm and have had the colostomy for at least 3 months
- Is capable of understanding the experiment
- Have a BMI between 20-30 kg/m2
- Is willing to test the adhesives from the two Coloplast products, Athena and SenSura
- Is evaluated as suitable for inclusion according to cardiovascular test and fitness test performed at the screening
Exclusion
- Subjects who comply with the following criteria must be excluded from the investigation:
- Have dermatological problems
- Currently receiving or have within the past 2 months received radio- and/or chemotherapy.
- Have elevated cholesterol levels, elevated blood pressure, diabetes or any form of cardiovascular disease.
- Currently receiving or have within the last 3 weeks received local treatment with steroids (ointment or creme) on back or stomach\*
- Group A may not have a stoma
- Group B may not use convex base plates \* Radio- and chemotherapy can lead to changes in the skin and intestine. It is known that steroid can lead to fragile skin which can affect application and removal of the adhesive
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01245413
Start Date
November 1 2010
End Date
December 1 2010
Last Update
January 1 2013
Active Locations (1)
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1
Lægernes Test Center A/S
Skodsborg, Denmark, 2942