Trial Outcomes & Findings for Investigation of the Performance of Ostomy Base Plate (NCT NCT01103466)
NCT ID: NCT01103466
Last Updated: 2013-04-04
Results Overview
Area of leakage under the base plate is recorded on a circular scale going from 0 fields to 24 fields where 0 is "no leakage" and 24 is "complete leakage" under the base plate.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
41 participants
Primary outcome timeframe
At every change of base plate
Results posted on
2013-04-04
Participant Flow
Subjects were recruited from a user database in Denmark.
41 subjects were enrolled, however 6 subjects did not comply with the inclusion and exclusion criteria. Four of these were terminated before testing any products. Whereas two subjects were included in the safety population as the inclusion criteria violation was first discovered after they tested a product.
Participant milestones
| Measure |
Atlas
New base plate
All subjects tested this test product in one period during the study.
No parcipitants recieved the same study intervention more than once
|
SenSura
Commercially available base plate
All subjects tested this test product in one period during the study.
No parcipitants recieved the same study intervention more than once
|
Conform2
Commercially available base plate
All subjects tested this test product in one period during the study.
No parcipitants recieved the same study intervention more than once
|
|---|---|---|---|
|
First Period (14 +/- 3 Days)
STARTED
|
12
|
12
|
13
|
|
First Period (14 +/- 3 Days)
COMPLETED
|
10
|
12
|
13
|
|
First Period (14 +/- 3 Days)
NOT COMPLETED
|
2
|
0
|
0
|
|
Second Period (14 +/- 3 Days)
STARTED
|
15
|
13
|
7
|
|
Second Period (14 +/- 3 Days)
COMPLETED
|
13
|
11
|
6
|
|
Second Period (14 +/- 3 Days)
NOT COMPLETED
|
2
|
2
|
1
|
|
Third Period (14 +/- 3 Days)
STARTED
|
8
|
8
|
14
|
|
Third Period (14 +/- 3 Days)
COMPLETED
|
6
|
8
|
13
|
|
Third Period (14 +/- 3 Days)
NOT COMPLETED
|
2
|
0
|
1
|
Reasons for withdrawal
| Measure |
Atlas
New base plate
All subjects tested this test product in one period during the study.
No parcipitants recieved the same study intervention more than once
|
SenSura
Commercially available base plate
All subjects tested this test product in one period during the study.
No parcipitants recieved the same study intervention more than once
|
Conform2
Commercially available base plate
All subjects tested this test product in one period during the study.
No parcipitants recieved the same study intervention more than once
|
|---|---|---|---|
|
First Period (14 +/- 3 Days)
Protocol Violation
|
2
|
0
|
0
|
|
Second Period (14 +/- 3 Days)
Adverse Event
|
2
|
1
|
0
|
|
Second Period (14 +/- 3 Days)
Lack of Efficacy
|
0
|
1
|
1
|
|
Third Period (14 +/- 3 Days)
Adverse Event
|
1
|
0
|
0
|
|
Third Period (14 +/- 3 Days)
Lack of Efficacy
|
1
|
0
|
0
|
|
Third Period (14 +/- 3 Days)
not satisfied with product
|
0
|
0
|
1
|
Baseline Characteristics
Investigation of the Performance of Ostomy Base Plate
Baseline characteristics by cohort
| Measure |
All Study Parcipitants
n=35 Participants
All parcipitants recieved all three intervention and they are therefore combined into one group.
|
|---|---|
|
Age Continuous
|
56 years
STANDARD_DEVIATION 13.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At every change of base platePopulation: ITT
Area of leakage under the base plate is recorded on a circular scale going from 0 fields to 24 fields where 0 is "no leakage" and 24 is "complete leakage" under the base plate.
Outcome measures
| Measure |
Atlas
n=35 Participants
new base plate
|
SenSura
n=33 Participants
base plate
|
Conform2
n=34 Participants
base plate
|
|---|---|---|---|
|
Leakage Under the Base Plate
|
8.2 units on a scale
Standard Deviation 5.0
|
5.5 units on a scale
Standard Deviation 4.8
|
8.0 units on a scale
Standard Deviation 4.9
|
Adverse Events
Atlas
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
SenSura
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Conform2
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Atlas
n=35 participants at risk
new base plate
|
SenSura
n=33 participants at risk
base plate
|
Conform2
n=34 participants at risk
base plate
|
|---|---|---|---|
|
Gastrointestinal disorders
Volvulus
|
5.7%
2/35 • Number of events 2 • Adverse event data was collected from inclusion to the end of the three test periods (~43 days).
The safety population contained 37 subjects, whereof two subjects were excluded from the ITT population due to inclusion criteria violation and did not try any test products.
|
0.00%
0/33 • Adverse event data was collected from inclusion to the end of the three test periods (~43 days).
The safety population contained 37 subjects, whereof two subjects were excluded from the ITT population due to inclusion criteria violation and did not try any test products.
|
0.00%
0/34 • Adverse event data was collected from inclusion to the end of the three test periods (~43 days).
The safety population contained 37 subjects, whereof two subjects were excluded from the ITT population due to inclusion criteria violation and did not try any test products.
|
Other adverse events
| Measure |
Atlas
n=35 participants at risk
new base plate
|
SenSura
n=33 participants at risk
base plate
|
Conform2
n=34 participants at risk
base plate
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
skin irritation
|
14.3%
5/35 • Number of events 5 • Adverse event data was collected from inclusion to the end of the three test periods (~43 days).
The safety population contained 37 subjects, whereof two subjects were excluded from the ITT population due to inclusion criteria violation and did not try any test products.
|
3.0%
1/33 • Number of events 1 • Adverse event data was collected from inclusion to the end of the three test periods (~43 days).
The safety population contained 37 subjects, whereof two subjects were excluded from the ITT population due to inclusion criteria violation and did not try any test products.
|
17.6%
6/34 • Number of events 7 • Adverse event data was collected from inclusion to the end of the three test periods (~43 days).
The safety population contained 37 subjects, whereof two subjects were excluded from the ITT population due to inclusion criteria violation and did not try any test products.
|
|
Gastrointestinal disorders
faeces leakage under base plate
|
2.9%
1/35 • Number of events 1 • Adverse event data was collected from inclusion to the end of the three test periods (~43 days).
The safety population contained 37 subjects, whereof two subjects were excluded from the ITT population due to inclusion criteria violation and did not try any test products.
|
0.00%
0/33 • Adverse event data was collected from inclusion to the end of the three test periods (~43 days).
The safety population contained 37 subjects, whereof two subjects were excluded from the ITT population due to inclusion criteria violation and did not try any test products.
|
0.00%
0/34 • Adverse event data was collected from inclusion to the end of the three test periods (~43 days).
The safety population contained 37 subjects, whereof two subjects were excluded from the ITT population due to inclusion criteria violation and did not try any test products.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place