Study Evaluating a New Ostomy Appliance With Regard to Leakage, Handling and Comfort

Study Overview
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Brief Summary
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The objective of this investigation is to evaluate leakage, handling and comfort of a new ostomy appliance compared to SenSura.

Detailed Description
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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.

Official Title
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Cross-over, Open Label Study Evaluating a New Ostomy Appliance With Regard to Leakage, Handling and Comfort

Conditions
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Colostomy

Intervention / Treatment
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* Device: SS
* Device: SenSura


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SenSura<br>CE marked and launched (The letters CE do not represent any specific words, though may have initially stood for Communauté Européenne (European Community) or Conformité Européenne (European Conformity). By affixing the CE marking to a product, the manufacturer declares that it meets EU safety and health and environmental requirements. | Device: SS<br>* New ostomy appliance (SS) is tested in 10 ± 2 days and the degree of leakage under the baseplate is measured and compared to SenSura.<br>* Other names: New ostomy appliance;Device: SenSura<br>* New ostomy appliance (SS) is tested in 10 ± 2 days and the degree of leakage under the baseplate is measured and compared to SenSura.<br>* Other names: New ostomy appliance;|
| Active Comparator: New ostomy appliance (SS)<br>SS = New ostomy appliance. Due to company confidentiality the product is just called SS and this is not short for any other names. | Device: SS<br>* New ostomy appliance (SS) is tested in 10 ± 2 days and the degree of leakage under the baseplate is measured and compared to SenSura.<br>* Other names: New ostomy appliance;Device: SenSura<br>* New ostomy appliance (SS) is tested in 10 ± 2 days and the degree of leakage under the baseplate is measured and compared to SenSura.<br>* Other names: New ostomy appliance;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Safety is evaluated by adverse events occuring continues while the subjects are testing the devices | 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' | 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' | 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' | 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. | After each base plate change measured over a period of 10 +/- 2 days. Base plates are changed 1-6 times a day |