The objective of this investigation is to evaluate leakage, handling and comfort of a new ostomy appliance compared to SenSura.
Peristomal skin problems are reported to have a negative impact on the quality of life of people with a stoma and cause one third of all visits to a stoma care nurse. Stoma effluent in contact with the peristomal skin (leakage) appears to predispose patients to peristomal skin problems. To protect the skin against effluent, the appliance used for collection of stoma effluent should completely cover the peristomal skin close to the stoma. Coloplast has developed a new ostomy appliance to improve the feeling of security and increase comfort by the appliance characteristics. The objective of this investigation is to evaluate leakage, handling and comfort of a new ostomy appliance compared to SenSura. The study is a randomised controlled cross-over intervention study, where all study participants will test two test products (new ostomy appliance and SenSura). Each test period will last 10 ± 2 days and the subjects will follow their usual wear and change pattern. The participants will visit the study investigator at study start and at cross-over. Evaluation of the test products will occur via questionnaires the subjects fill in at home. 50 healthy subjects with a colostomy will be included in the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
56
Coloplast A/S
Humlebæk, Denmark
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
Time frame: After each base plate change measured over a period of 10 +/- 2 days. Base plates are changed 1-6 times a day
Adverse Events
Safety is evaluated by adverse events occuring continues while the subjects are testing the devices
Time frame: During the investigation ~ 24 days per subject
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'
Time frame: After each test period, i.e. after 10 (±2) days with one test product and after 10 (±2) days with the other test product
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'
Time frame: After each test period, i.e. after 10 (±2) days with one test product and after 10 (±2) days with the other test product
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'
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Time frame: After each test period, i.e. after 10 (±2) days with one test product and after 10 (±2) days with the other test product
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.
Time frame: After each base plate change measured over a period of 10 +/- 2 days. Base plates are changed 1-6 times a day