Colostomy Clinical Trial
Official title:
Cross-over, Open Label Study Evaluating a New Ostomy Appliance With Regard to Leakage, Handling and Comfort
The objective of this investigation is to evaluate leakage, handling and comfort of a new ostomy appliance compared to SenSura.
Status | Completed |
Enrollment | 56 |
Est. completion date | November 2010 |
Est. primary completion date | November 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Have given written informed consent - Be at least 18 years of age and have full legal capacity - Be able to handle the bags themselves (application, removal) - Have a colostomy with a diameter less than 45 mm - Have had a colostomy for at least 3 months - Currently use a 1-piece flat ostomy appliance with closed bag - is suitable for treatment with a standard adhesive, flat base plate (evaluated by nurse) - Use minimum 1 product per day - Be willing to test a new Coloplast one-piece custom cut ostomy appliance size midi or maxi for 10 days and SenSura (1- piece open ostomy bag custom cut ostomy appliance) size midi or maxi for 10 days - Have the mental capacity to understand the study and questionnaires Exclusion Criteria: - Use irrigation during the study (flush the stoma with water). - Currently suffering from peristomal skin problems (i.e. bleeding or red and broken skin) - Currently receiving or have within the last 2 months received chemotherapy or radiation therapy - Currently receive or have within the past three weeks been receiving steroid medication in the peristomal area. - Are pregnant or breastfeeding |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
Denmark | Coloplast A/S | Humlebæk |
Lead Sponsor | Collaborator |
---|---|
Coloplast A/S |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Leakage (Percent of All Base Plates With Leakage) | Leakage is evaluated after each change of base plate on a 4-point scale from no leakage, leakage on the base plate, leakage soiling clothe and sudden leakage - the 3 last mentioned are all defined as leakage. No leakage is the preferred end point | After each base plate change measured over a period of 10 +/- 2 days. Base plates are changed 1-6 times a day | No |
Secondary | Adverse Events | Safety is evaluated by adverse events occuring continues while the subjects are testing the devices | During the investigation ~ 24 days per subject | Yes |
Secondary | Security (Subjects Own Assessment) | Results of participants who answered on own assessment of security on a 5 point scale ('very poor', 'poor', 'acceptable', 'good' and 'very good'). 'Good' and 'very good' are the preferred end points The 'very good' result are presented here. Unit of measure is: Percentage of participants answering 'very good' |
After each test period, i.e. after 10 (±2) days with one test product and after 10 (±2) days with the other test product | No |
Secondary | Handling at Appliance (Subjects Own Assessment) | Handling at appliance where evaluated by subjects own assessment on a 5 point scale from very difficult to very easy. Results of participants who answered on own feeling of handling at appliance on a 5 point scale (very difficult, difficult, acceptable, easy, very easy). Easy and very easy are the preferred end points and it is the these results that are presented here. Unit of measure is: Percentage of participants answering 'very easy' and 'easy' |
After each test period, i.e. after 10 (±2) days with one test product and after 10 (±2) days with the other test product | No |
Secondary | Comfort (Subjects Own Assessment) | Comfort where evaluated by subjects own assessment on a 5 point scale from very uncomfortable to very comfortable. Results of participants who answered on own assessment of comfort of wearing the product on a 5 point scale (very uncomfortable, uncomfortable, acceptable, comfortable, very comfortable). Comfortable and very comfortable are the preferred end points and it is these results that are presented here. Unit of measure is: Percentage of participants answering 'very comfortable' and 'comfortable' |
After each test period, i.e. after 10 (±2) days with one test product and after 10 (±2) days with the other test product | No |
Secondary | Wear Time (Registered by Subject When Applying and Removing a Product) | Wear time was calculated from the time the subjects applied their product (date, year, time) to the time they detached the product (date, year, time). Wear time was estimated in hours per subject per base plate and mean value was calculated. | After each base plate change measured over a period of 10 +/- 2 days. Base plates are changed 1-6 times a day | No |
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