Stoma Colostomy
Conditions
Brief summary
The purpose of the study is to evaluate leakage of a newly developed ostomy product compared to standard care in subjects with colostomies. Subjects will be asked to use each test product for 2 weeks - in total, the study period is 4 weeks and the hypothesis is to show that the newly developed ostomy product is significantly better to reduce leakage compared to standard care.
Interventions
DEVICESenSura Mio
Ostomy product - 1 piece closed bag
DEVICEStandard Care
Ostomy product 1 piece closed bags. Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima.
Sponsors
Coloplast A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Have given written informed consent. 2. Be at least 18 years of age and have full legal capacity. 3. Have experienced leakage under the base plate at least once a week over the last two weeks. 4. Be able to handle the bags themselves or with help from caregiver (e.g. spouse). 5. Have a colostomy with a diameter between 20 and 45 mm. 6. Have had their ostomy for at least three months. 7. Currently use a 1-piece flat product with closed bag. 8. Use minimum 1 product per day. 9. Be suitable for participation in the investigation and for using a standard adhesive, flat base plate (evaluated by investigator).
Exclusion criteria
1. Use irrigation during the study (flush the stoma with water). 2. Currently receiving or have within the past 2 months received radio- and/or chemotherapy. 3. Currently receiving or have within the past month received local or systemic steroid treatment in the peristomal area. 4. Are pregnant or breastfeeding. 5. Participating in other interventional clinical investigations or have previously participated in this investigation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Degree of Leakage. Each Baseplate Can Have a Score From 0-24 Points Were 0 is the Best Possible Outcome (No Leakage) and 24 Points is the Worst Possible Outcome (Full Plate Leakage) | 14 days | Degree of leakage will be measured by a 25-point leakage scale (no leakage or up till 24 points of leakage), developed by Coloplast A/S. The subjects receive Petri dishes with pre-printed leakage scale on. The subject will place the Petri dish above the used baseplate and indicate where on the baseplate output appears. This is done by ticking of each area on the scale indicating the area of leakage. |
Countries
Germany
Participant flow
Recruitment details
The subjects were recruited via sites and user data-bases in Denmark, Norway, Germany and France.
Participants by arm
| Arm | Count |
|---|---|
| Entire Study Population Entire study population = all participants enrolled in the study | 122 |
| Total | 122 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| SenSura Mio First, | Adverse Event | 2 | 0 |
| SenSura Mio First, | Lack of Efficacy | 0 | 1 |
| SenSura Mio First, | Other | 1 | 0 |
| SenSura Mio First, | Withdrawal by Subject | 1 | 1 |
| Standard Care First, | Lack of Efficacy | 2 | 2 |
| Standard Care First, | Other | 1 | 0 |
| Standard Care First, | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Entire Study Population |
|---|---|
| Age, Continuous | 65.3 years STANDARD_DEVIATION 11.7 |
| Sex: Female, Male Female | 63 Participants |
| Sex: Female, Male Male | 59 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 10 / 120 | 10 / 118 |
| serious Total, serious adverse events | 0 / 120 | 0 / 118 |
Outcome results
Primary
Degree of Leakage. Each Baseplate Can Have a Score From 0-24 Points Were 0 is the Best Possible Outcome (No Leakage) and 24 Points is the Worst Possible Outcome (Full Plate Leakage)
Degree of leakage will be measured by a 25-point leakage scale (no leakage or up till 24 points of leakage), developed by Coloplast A/S. The subjects receive Petri dishes with pre-printed leakage scale on. The subject will place the Petri dish above the used baseplate and indicate where on the baseplate output appears. This is done by ticking of each area on the scale indicating the area of leakage.
Time frame: 14 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SenSura Mio | Degree of Leakage. Each Baseplate Can Have a Score From 0-24 Points Were 0 is the Best Possible Outcome (No Leakage) and 24 Points is the Worst Possible Outcome (Full Plate Leakage) | 3.8 points on a scale | Standard Deviation 5 |
| Standard Care | Degree of Leakage. Each Baseplate Can Have a Score From 0-24 Points Were 0 is the Best Possible Outcome (No Leakage) and 24 Points is the Worst Possible Outcome (Full Plate Leakage) | 3.4 points on a scale | Standard Deviation 4.4 |