Surgical Stomas
Conditions
Brief summary
Open-label, randomized, controlled, comparative, cross-over study with 2 test sequences comparing a new 2-piece coupling system with SenSura Mio Click.
Detailed description
It will be a 1:1 randomization into the two possible treatment sequences Each test period is 3 weeks (± 2 days), total study period is 6 weeks (± 4 days). All visits will be performed as remote virtual calls. At the visits, the investigator will give instructions for the coming period and check that the trial is running as planned. At every bag change the subject will be asked to complete a questionnaire. A follow-up call will be scheduled 7±1 days after each test visit to ensure compliance with the provided product and study procedures. Additional calls may be scheduled if needed. Minimum 40 participants will be enrolled and randomized.
Interventions
DEVICENew 2-piece Coupling
Flat or concave baseplate. SenSura Mio Click maxi bag (open, wide outlet) with new 50mm Ø coupling.
DEVICESenSura Mio Click
Flat or concave baseplate. SenSura Mio Click maxi bag (open, wide outlet) with 50mm Ø coupling.
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. Has given written consent to participate by signing the Informed Consent Signature Form 2. Be at least 18 years of age and have full legal capacity 3. Is able to handle (apply, remove, cut, etc.) the product and do the assessments themselves 4. Has an ileostomy or colostomy with consistent liquid fecal output (for colostomy: 6-7 Bristol stool scale) 5. Currently use SenSura Mio Click 2p Click flat or concave with 50 mm coupling size 6. Have had their ostomy for at least 90 days 7. Be willing to change the bag at least twice per week 8. Is willing and suitable (determined by the Principal Investigator or designee) to use flat or concave 2p open product during the investigation 9. Is willing to use 2p maxi open bags during the investigation
Exclusion criteria
1. Is currently receiving or have within the past 60 days received radio-and/or chemotherapy \- Low doses radio- and/or chemotherapy (assessed by Principal Investigator) is allowed for indications other than cancer. 2. Is currently receiving or have within the past 30 days received topical steroid treatment in the peristomal skin area, e.g., lotion or spray * Low dose systemic steroid treatment (e.g., inhalation) assessed by the investigator are allowed. * Other systemic steroid treatment (e.g., injection or tablet) are not allowed. 3. Is pregnant and/or breast-feeding 4. Have a loop ileostomy 5. Is currently using convex baseplate 6. Has known hypersensitivity towards any of the products used in the investigation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Leakage Through Coupling Registered at Each Bag Change (Yes/no) | 3 weeks | Output visible inside and/or outside the coupling system when the bag is changed. Presented in proportion of bag changes (with leakage) per participant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| How Satisfied Are You With the New Coupling? | 3 weeks - evaluated at the end of the study | Satisfaction with new coupling evaluated at end of study by a question on a 4-point scale (very satisfied - satisfied - dissatisfied - very dissatisfied) |
| Would You Consider Using the New Coupling in the Future? | Based on 3 weeks - evaluated at the end of the study period | Preference evaluated at end of the investigation by the question Would you consider using the new coupling in the future? (Yes/No) |
Countries
United States
Participant flow
Recruitment details
First Patient In: 15 Feb 2023 Last Patient Out: 17 July 2023
Pre-assignment details
51 participants were enrolled. After enrolment, one participant was excluded due to meeting exclusion crit. 5. Three participants wished to discontinue before randomization. Therefore, only 47 started in the treatment arms, while the safety population was 51.
Participants by arm
| Arm | Count |
|---|---|
| All Participants Demographics are described for the total Intention-to-Treat (ITT) population | 47 |
| Total | 47 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention | Withdrawal by Subject | 0 | 1 |
| Second Intervention | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | All Participants | — |
|---|---|---|
| Age, Continuous | 55.6 years STANDARD_DEVIATION 13.3 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 18 Participants | — |
| Sex: Female, Male Male | 29 Participants | — |
| Stoma type Colostomy | 19 Participants | — |
| Stoma type Ileostomy | 28 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 47 | 0 / 47 |
| other Total, other adverse events | 0 / 47 | 1 / 47 |
| serious Total, serious adverse events | 0 / 47 | 0 / 47 |
Outcome results
Primary
Leakage Through Coupling Registered at Each Bag Change (Yes/no)
Output visible inside and/or outside the coupling system when the bag is changed. Presented in proportion of bag changes (with leakage) per participant.
Time frame: 3 weeks
Population: ITT
| Arm | Measure | Value (MEAN) |
|---|---|---|
| New Coupling | Leakage Through Coupling Registered at Each Bag Change (Yes/no) | 0.151 Proportion of bag changes/participant |
| Comparator Device | Leakage Through Coupling Registered at Each Bag Change (Yes/no) | 0.237 Proportion of bag changes/participant |
p-value: 0.16495% CI: [0.2634, 1.2659]Mixed Models Analysis
Secondary
How Satisfied Are You With the New Coupling?
Satisfaction with new coupling evaluated at end of study by a question on a 4-point scale (very satisfied - satisfied - dissatisfied - very dissatisfied)
Time frame: 3 weeks - evaluated at the end of the study
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| New Coupling | How Satisfied Are You With the New Coupling? | 35 Participants |
| Comparator Device | How Satisfied Are You With the New Coupling? | 4 Participants |
p-value: <0.000195% CI: [0.75, 0.97]Exact test in the binomial distribution
Secondary
Would You Consider Using the New Coupling in the Future?
Preference evaluated at end of the investigation by the question Would you consider using the new coupling in the future? (Yes/No)
Time frame: Based on 3 weeks - evaluated at the end of the study period
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| New Coupling | Would You Consider Using the New Coupling in the Future? | 32 Participants |
| Comparator Device | Would You Consider Using the New Coupling in the Future? | 7 Participants |
p-value: <0.000195% CI: [0.66, 0.92]Exact test in the binominal distribution
Post Hoc
Leakage Visible Outside the Coupling
Leakage from coupling, visible outside coupling on baseplate when the bag is changed. Presented in proportion of bag changes (with leakage) per participant.
Time frame: 3 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| New Coupling | Leakage Visible Outside the Coupling | 0.012 Proportion of bag changes/participant |
| Comparator Device | Leakage Visible Outside the Coupling | 0.044 Proportion of bag changes/participant |
p-value: 0.02795% CI: [0.078, 0.855]Mixed Models Analysis