Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SenSura | Active Comparator | 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. |
|
| New ostomy appliance (SS) | Active Comparator | SS = New ostomy appliance. Due to company confidentiality the product is just called SS and this is not short for any other names. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SS | Device | New ostomy appliance (SS) is tested in 10 ± 2 days and the degree of leakage under the baseplate is measured and compared to SenSura. |
|
| 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 |
| 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pia Nordmand, MSc | Coloplast A/S | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coloplast A/S | Humlebæk | 3050 | Denmark |
56 subject where enrolled, however two subjects did not comply to the in- and exclusion criteria and was hence terminated before testing any devices
Subjects recruited from a user database in Denmark and through six hospital sites in France between august and november 2010
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | SenSura First, Then SS | SS = new ostomy bag. SS used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a colostomy. SenSura used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a stoma (e.g. a ileostomy or a colostomy). Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage. The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test. |
| FG001 | SS First, Then SenSura | SS = new ostomy bag. SS used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a colostomy. SenSura used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a stoma (e.g. a ileostomy or a colostomy). Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage. The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (10 Days +/- 2 Days) |
| |||||||||||||
| Second Intervention (10 Days +/- 2 Days) |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | Includes groups randomized to receive SS (new ostomy bag)first and SenSura first |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Intention to treat. As this is a cross-over investigation 26 started at SS and crossed over to SenSura, and 28 started at SenSura and crossed to SS leading to a total population of 54 evaluating each medical device | Posted | Number | Percent of Base plates | After each base plate change measured over a period of 10 +/- 2 days. Base plates are changed 1-6 times a day | Base plates | Participants |
|
AE data where collected from inclusion to the two test periods where completed (~24 days)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SenSura | Base plates applied 1 till 6 times a day |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Redness and skin damage | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Rated as related to medical device. Moderate severity. Device used while experiencing adverse event: SenSura |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pia Nordmand, Clinical Trial Manager | Coloplast A/S | +4549113250 | dkpialn@coloplast.com |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| SenSura | Device | New ostomy appliance (SS) is tested in 10 ± 2 days and the degree of leakage under the baseplate is measured and compared to SenSura. |
|
|
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 |
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | SenSura | CE marked and launched SenSura used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a stoma (e.g. a ileostomy or a colostomy). Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage. The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test. |
|
|
| Secondary | Adverse Events | Safety is evaluated by adverse events occuring continues while the subjects are testing the devices | As this is a cross-over investigation 26 started at SS and crossed over to SenSura, and 28 started at SenSura and crossed to SS leading to a total population of 54 evaluating each medical device. Population is ITT | Posted | Mar 2011 | Number | Adverse events | During the investigation ~ 24 days per subject |
|
|
|
| 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' | As this is a cross-over investigation 26 started at SS and crossed over to SenSura, and 28 started at SenSura and crossed to SS leading to a total population of 54 evaluating each medical device. Population is ITT | Posted | Mar 2011 | Number | Percent of participants | After each test period, i.e. after 10 (±2) days with one test product and after 10 (±2) days with the other test product |
|
|
|
| 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' | As this is a cross-over investigation 26 started at SS and crossed over to SenSura, and 28 started at SenSura and crossed to SS leading to a total population of 54 evaluating each medical device. Population is ITT | Posted | Mar 2011 | Number | Percent of participants | After each test period, i.e. after 10 (±2) days with one test product and after 10 (±2) days with the other test product |
|
|
|
| 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' | As this is a cross-over investigation 26 started at SS and crossed over to SenSura, and 28 started at SenSura and crossed to SS leading to a total population of 54 evaluating each medical device. Population is ITT | Posted | Mar 2011 | Number | Percent of participants | After each test period, i.e. after 10 (±2) days with one test product and after 10 (±2) days with the other test product |
|
|
|
| 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. | As this is a cross-over investigation 26 started at SS and crossed over to SenSura, and 28 started at SenSura and crossed to SS leading to a total population of 54 evaluating each medical device. Population is ITT | Posted | Mar 2011 | Mean | Standard Deviation | Hours | After each base plate change measured over a period of 10 +/- 2 days. Base plates are changed 1-6 times a day | Base plates | Participants |
|
|
|
| 0 |
| 54 |
| 2 |
| 54 |
| EG001 | SS (New Ostomy Bag) | Base plates applied 1 till 6 times a day SS = new ostomy bag | 0 | 54 | 1 | 54 |
|
| Peripheral lesions from 5 cm (peripheral edges) | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Rated as related to medical device. Moderate severity. Device used while experiencing adverse event: SenSura |
|
| Redness on skin 0-2 cm from stoma edge | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Rated as related to medical device. Mild severity. Device used while experiencing adverse event: SS (new ostomy appliance) |
|
Not provided
Not provided
Not provided