Trial Outcomes & Findings for Multi-national, Safety and Performance Study of New Ostomy Product Compared to Standard Care (NCT NCT01517178)
NCT ID: NCT01517178
Last Updated: 2015-03-13
Results Overview
Degree of output is measured by a 24-point leakage assessment scale (0 indicating no leakage and 24 indicating maximum leakage).
TERMINATED
PHASE3
33 participants
Each test product was assessed for 2 weeks.
2015-03-13
Participant Flow
A total of 33 subjects were enrolled in the trial. Of these, 6 discontinued during the New ostomy base plate run-in period prior to period 1 and were excluded from the Intention-To-Treat analysis set (no performance data obtained). 27 subjects comprised the intention-to-treat population.
Participant milestones
| Measure |
Standard Care - New Ostomy Base Plate
Subjects first test Standard Care then New ostomy base plate.
|
New Ostomy Base Plate - Standard Care
Subjects first test New ostomy base plate then Standard Care.
|
|---|---|---|
|
Period 1
STARTED
|
16
|
11
|
|
Period 1
COMPLETED
|
12
|
6
|
|
Period 1
NOT COMPLETED
|
4
|
5
|
|
Period 2
STARTED
|
11
|
6
|
|
Period 2
COMPLETED
|
5
|
4
|
|
Period 2
NOT COMPLETED
|
6
|
2
|
Reasons for withdrawal
| Measure |
Standard Care - New Ostomy Base Plate
Subjects first test Standard Care then New ostomy base plate.
|
New Ostomy Base Plate - Standard Care
Subjects first test New ostomy base plate then Standard Care.
|
|---|---|---|
|
Period 1
Adverse Event
|
1
|
2
|
|
Period 1
Lack of Efficacy
|
0
|
1
|
|
Period 1
E.g. study termination
|
3
|
1
|
|
Period 1
Withdrawal by Subject
|
0
|
1
|
|
Period 2
Adverse Event
|
1
|
0
|
|
Period 2
Withdrawal by Subject
|
3
|
0
|
|
Period 2
E.g. study termination
|
2
|
2
|
Baseline Characteristics
Multi-national, Safety and Performance Study of New Ostomy Product Compared to Standard Care
Baseline characteristics by cohort
| Measure |
Intention-to-treat Analysis Set
n=27 Participants
|
|---|---|
|
Age, Continuous
|
54.9 years
STANDARD_DEVIATION 12.8 • n=99 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
|
Region of Enrollment
France
|
6 participants
n=99 Participants
|
|
Region of Enrollment
Denmark
|
19 participants
n=99 Participants
|
|
Region of Enrollment
Iceland
|
1 participants
n=99 Participants
|
|
Region of Enrollment
Germany
|
1 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Each test product was assessed for 2 weeks.Degree of output is measured by a 24-point leakage assessment scale (0 indicating no leakage and 24 indicating maximum leakage).
Outcome measures
| Measure |
Standard Care Base Plate
n=122 Baseplates
|
New Ostomy Base Plate
n=104 Baseplates
|
|---|---|---|
|
Degree of Output Under the Base Plate (Leakage).
|
4.6 units on a scale
Standard Deviation 3.5
|
6.5 units on a scale
Standard Deviation 5.0
|
Adverse Events
Standard Care Base Plate
New Ostomy Base Plate
Serious adverse events
| Measure |
Standard Care Base Plate
n=21 participants at risk
Safety population includes subjects allocated to test period (no run-in period)
|
New Ostomy Base Plate
n=30 participants at risk
Safety population includes subjects allocated to run-in period and test period.
|
|---|---|---|
|
Infections and infestations
Infection in parastomal prosthetic mesh
|
0.00%
0/21
|
3.3%
1/30 • Number of events 1
|
Other adverse events
| Measure |
Standard Care Base Plate
n=21 participants at risk
Safety population includes subjects allocated to test period (no run-in period)
|
New Ostomy Base Plate
n=30 participants at risk
Safety population includes subjects allocated to run-in period and test period.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Peristomal skin irritation
|
0.00%
0/21
|
16.7%
5/30 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Adhesive issue
|
0.00%
0/21
|
30.0%
9/30 • Number of events 9
|
|
Skin and subcutaneous tissue disorders
Lack of effectiveness
|
0.00%
0/21
|
3.3%
1/30 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60