Stoma Colostomy, Stoma Ileostomy
Conditions
Brief summary
The aim of the investigation was to investigate the performance and safety of a new ostomy product
Interventions
DEVICEColoplast Test
Newly developed 1-piece convex ostomy product
DEVICEOwn product
The subjects Own product is used as baseline performance in this investigation. The products are commercial and available on the market, and are products manufactured by manufactures who produce convex ostomy products i.e. Coloplast, Convatec, Dansac, B.Braun, Hollister and more.
DEVICECompetitor soft convex
A commercially available soft convex product
Sponsors
Coloplast A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Are at least 18 years of age and have full legal capacity. * Have had an ileostomy/colostomy for more than 3 months * Have used a 1-piece flat ostomy product for the last 1 month * Has given written Informed Consent and signed the letter of authority * Have an ileostomy or colostomy with a diameter of 33 mm or less * Has experienced leakage (seeping) under the baseplate at least three times during the last two weeks * Are evaluated to be suitable for a soft convex product * If having a colostomy: changes their product on average 2 times pr. 24h or more * Currently uses a bag of size medi/midi or maxi
Exclusion criteria
* Have a loop ostomy (also called double-barrel or ostomy with two outlets). * Are pregnant or breastfeeding * Currently receiving or have within the past 2 month received radio- and/or chemotherapy * Currently receiving or have within the past month received systemic or local steroid treatment in the peristomal area * Currently suffering from peristomal skin problems (i.e. bleeding or broken skin). * Known hypersensitivity toward any of the test products * Participating in other interventional clinical investigations or have previously participated in this investigation * Use irrigation during the investigation (flush the intestine with water) * Have a fistula in the peristomal area or less than 2 cm from the edge of the baseplate * If subject has a colostomy: empties the bag
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Degree of Leakage | 14 +/- 3 days | The degree of leakage is investigated on a 32-point scale (including 0 for no leakage). O represents no leakage and 32 represents the worst leakage. |
Countries
Denmark
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Subjects Pooled data from all arms. | 38 |
| Total | 38 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Period 1 | Adverse Event | 0 | 0 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | All Subjects |
|---|---|
| Age, Continuous | 62.3 years STANDARD_DEVIATION 13.6 |
| Region of Enrollment Denmark | 38 participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 22 / 37 | 12 / 38 | 23 / 37 |
| serious Total, serious adverse events | 1 / 37 | 1 / 38 | 0 / 37 |
Outcome results
Primary
Degree of Leakage
The degree of leakage is investigated on a 32-point scale (including 0 for no leakage). O represents no leakage and 32 represents the worst leakage.
Time frame: 14 +/- 3 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coloplast Test Product | Degree of Leakage | 2.6 units on a scale | Standard Deviation 4.8 |
| Own Product | Degree of Leakage | 4.8 units on a scale | Standard Deviation 5.7 |
| Competitor Soft Convex | Degree of Leakage | 2.5 units on a scale | Standard Deviation 4.3 |