Colostomy
Conditions
Brief summary
The objective of this investigation is to evaluate leakage, handling and comfort of a new ostomy appliance compared to SenSura.
Detailed description
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.
Interventions
Sponsors
Coloplast A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Leakage (Percent of All Base Plates With Leakage) | After each base plate change measured over a period of 10 +/- 2 days. Base plates are changed 1-6 times a day | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | During the investigation ~ 24 days per subject | Safety is evaluated by adverse events occuring continues while the subjects are testing the devices |
| Security (Subjects Own Assessment) | After each test period, i.e. after 10 (±2) days with one test product and after 10 (±2) days with the other test product | 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' |
| Handling at Appliance (Subjects Own Assessment) | 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 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' |
| Comfort (Subjects Own Assessment) | 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 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' |
| Wear Time (Registered by Subject When Applying and Removing a Product) | After each base plate change measured over a period of 10 +/- 2 days. Base plates are changed 1-6 times a day | 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. |
Countries
Denmark
Participant flow
Recruitment details
Subjects recruited from a user database in Denmark and through six hospital sites in France between august and november 2010
Pre-assignment details
56 subject where enrolled, however two subjects did not comply to the in- and exclusion criteria and was hence terminated before testing any devices
Participants by arm
| Arm | Count |
|---|---|
| Entire Study Population Includes groups randomized to receive SS (new ostomy bag)first and SenSura first | 54 |
| Total | 54 |
Baseline characteristics
| Characteristic | Entire Study Population |
|---|---|
| Age Continuous | 70.5 years STANDARD_DEVIATION 10.9 |
| Region of Enrollment Denmark | 39 participants |
| Region of Enrollment France | 15 participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 54 | 1 / 54 |
| serious Total, serious adverse events | 0 / 54 | 0 / 54 |
Outcome results
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
Time frame: After each base plate change measured over a period of 10 +/- 2 days. Base plates are changed 1-6 times a day
Population: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| New Adhesive SS | Leakage (Percent of All Base Plates With Leakage) | 27 Percent of Base plates |
| SenSura | Leakage (Percent of All Base Plates With Leakage) | 30 Percent of Base plates |
Secondary
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
Population: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| New Adhesive SS | Adverse Events | 1 Adverse events |
| SenSura | Adverse Events | 2 Adverse events |
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'
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
Population: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| New Adhesive SS | Comfort (Subjects Own Assessment) | 93 Percent of participants |
| SenSura | Comfort (Subjects Own Assessment) | 67 Percent of participants |
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'
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
Population: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| New Adhesive SS | Handling at Appliance (Subjects Own Assessment) | 89 Percent of participants |
| SenSura | Handling at Appliance (Subjects Own Assessment) | 91 Percent of participants |
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'
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
Population: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| New Adhesive SS | Security (Subjects Own Assessment) | 48 Percent of participants |
| SenSura | Security (Subjects Own Assessment) | 28 Percent of participants |
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.
Time frame: After each base plate change measured over a period of 10 +/- 2 days. Base plates are changed 1-6 times a day
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| New Adhesive SS | Wear Time (Registered by Subject When Applying and Removing a Product) | 11.46 Hours | Standard Deviation 7.07 |
| SenSura | Wear Time (Registered by Subject When Applying and Removing a Product) | 11.41 Hours | Standard Deviation 6.41 |