Trial Outcomes & Findings for Investigation of Newly Developed Ostomy Products in Subjects With Ileostomy (NCT NCT01994902)
NCT ID: NCT01994902
Last Updated: 2016-01-12
Results Overview
The degree of leakage is measured using a 33-point scale measuring leakage under the baseplate, where 0 points represents the best possible outcome (no leakage) and 33 points the worst possible outcome (leakage on the whole baseplate).
COMPLETED
NA
129 participants
28 +/- 3 days
2016-01-12
Participant Flow
129 subjects were randomized, but two of these subjects were not exposed to a product: one subject had a stoma diameter of 42 mm (violation to inclusion criteria no.8) and one subject had chemotherapy planned (exclusion criteria no.3). 127 subjects were therefore included in the ITT population.
Participant milestones
| Measure |
First Coloplast Test Product; Then SenSura Convex Light
The subjects test:
test period 1: Coloplast test product test period 2: SenSura Convex Light
.
|
First SenSura Convex Light; Then Coloplast Test Product
The subjects test:
test period 1: SenSura Convex Light test period 2: Coloplast test product
|
|---|---|---|
|
Test Period 1
STARTED
|
63
|
64
|
|
Test Period 1
COMPLETED
|
57
|
61
|
|
Test Period 1
NOT COMPLETED
|
6
|
3
|
|
Test Period 2
STARTED
|
57
|
61
|
|
Test Period 2
COMPLETED
|
57
|
55
|
|
Test Period 2
NOT COMPLETED
|
0
|
6
|
Reasons for withdrawal
| Measure |
First Coloplast Test Product; Then SenSura Convex Light
The subjects test:
test period 1: Coloplast test product test period 2: SenSura Convex Light
.
|
First SenSura Convex Light; Then Coloplast Test Product
The subjects test:
test period 1: SenSura Convex Light test period 2: Coloplast test product
|
|---|---|---|
|
Test Period 1
Withdrawal by Subject
|
3
|
0
|
|
Test Period 1
device deficiency with adverse event
|
0
|
1
|
|
Test Period 1
Adverse Event
|
2
|
1
|
|
Test Period 1
Lack of Efficacy
|
0
|
1
|
|
Test Period 1
bag too small
|
1
|
0
|
|
Test Period 2
Withdrawal by Subject
|
0
|
2
|
|
Test Period 2
Lack of Efficacy
|
0
|
1
|
|
Test Period 2
Other
|
0
|
3
|
Baseline Characteristics
Investigation of Newly Developed Ostomy Products in Subjects With Ileostomy
Baseline characteristics by cohort
| Measure |
Overall Study
n=127 Participants
The investigation is a cross-over investigation therefore the baseline data is given for the overall study population
|
|---|---|
|
Age, Continuous
|
58.8 years
STANDARD_DEVIATION 14.1 • n=99 Participants
|
|
Gender
Female
|
77 participants
n=99 Participants
|
|
Gender
Male
|
49 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 28 +/- 3 daysPopulation: The results presented above are the intention-to-treat results that were analysed as randomised. However, the adverse events are reported as treated and as 4 subjects did not follow the randomisation order there is a slight discrepancy between the participants number in the outcome and adverse events section.
The degree of leakage is measured using a 33-point scale measuring leakage under the baseplate, where 0 points represents the best possible outcome (no leakage) and 33 points the worst possible outcome (leakage on the whole baseplate).
Outcome measures
| Measure |
Coloplast Test Product
n=1967 baseplates
Leakage results obtained while subjects tested the Coloplast test product
|
SenSura Convex Light
n=1988 baseplates
The leakage results obtained while subjects were testing SenSura Convex Light
|
|---|---|---|
|
Degree of Leakage
|
5.1 units on a scale
Standard Deviation 5.8
|
5.8 units on a scale
Standard Deviation 5.8
|
Adverse Events
Coloplast Test Product
SenSura Convex Light
Serious adverse events
| Measure |
Coloplast Test Product
n=125 participants at risk
Adverse events reported by subjects testing Coloplast test product
|
SenSura Convex Light
n=120 participants at risk
Adverse events reported by subjects testing SenSura Convex Light
|
|---|---|---|
|
Renal and urinary disorders
urinary tract infection
|
0.80%
1/125 • Number of events 1
|
0.00%
0/120
|
|
Gastrointestinal disorders
acute abdominal pain
|
0.00%
0/125
|
0.83%
1/120 • Number of events 1
|
|
Infections and infestations
gastrientitis
|
0.80%
1/125 • Number of events 1
|
0.00%
0/120
|
|
Gastrointestinal disorders
stoma operation (revision of stome)
|
0.80%
1/125 • Number of events 1
|
0.00%
0/120
|
|
Gastrointestinal disorders
obstruction of stoma
|
0.80%
1/125 • Number of events 1
|
0.00%
0/120
|
|
Gastrointestinal disorders
Blocked stoma
|
0.00%
0/125
|
0.83%
1/120 • Number of events 1
|
|
Metabolism and nutrition disorders
dehydration
|
0.80%
1/125 • Number of events 1
|
0.00%
0/120
|
|
Renal and urinary disorders
renal failure
|
0.80%
1/125 • Number of events 1
|
0.00%
0/120
|
|
Infections and infestations
Severe sepsis in contex of intra abdominal infection
|
0.00%
0/125
|
0.83%
1/120 • Number of events 1
|
Other adverse events
| Measure |
Coloplast Test Product
n=125 participants at risk
Adverse events reported by subjects testing Coloplast test product
|
SenSura Convex Light
n=120 participants at risk
Adverse events reported by subjects testing SenSura Convex Light
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin irritations
|
22.4%
28/125 • Number of events 51
|
11.7%
14/120 • Number of events 26
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60