Trial Outcomes & Findings for The Influence of Baseplate Adhesive on the Degree of Leakage (NCT NCT01995357)
NCT ID: NCT01995357
Last Updated: 2015-02-03
Results Overview
The primary endpoint was the degree of leakage under the baseplate, which was assessed using the three innermost rings of the 32-point leakage scale, corresponding to a total of 24 points (0 indicating no leakage and 24 indicating maximum leakage). Results are given separately for subjects with colostomy and ileostomy. In the ileostomy group there were no SenSura Mio participants in the standard care group.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
10 (- 2 days)
Results posted on
2015-02-03
Participant Flow
Participant milestones
| Measure |
First Coloplast Teast A; Then Coloplast Test B
There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.
The test sequence in this arm is:
Coloplast Test A; Coloplast Test B; Standard product; Training + Coloplast Test A; Training + Coloplast Test B
Coloplast Test A: Coloplast Test A is a newly developed ostomy appliance
Coloplast Test B: Coloplast Test B is a newly developed ostomy appliance.
Standard product: Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation.
|
First Coloplast Test A; Then Standard Product
There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.
The test sequence in this arm is:
Coloplast Test A; Standard product; Coloplast Test B; ; Training + Coloplast Test A; Training + Coloplast Test B
Coloplast Test A: Coloplast Test A is a newly developed ostomy appliance
Coloplast Test B: Coloplast Test B is a newly developed ostomy appliance.
Standard product: Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation.
|
First Coloplast Test B; Then Colopast Test A
There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.
The test sequence in this arm is:
Coloplast Test B; Coloplast Test A; Standard product; Training + Coloplast Test B; Training + Coloplast Test A
Coloplast Test A: Coloplast Test A is a newly developed ostomy appliance
Coloplast Test B: Coloplast Test B is a newly developed ostomy appliance.
Standard product: Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation.
|
First Coloplast Test B; Then Standard Product
There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.
The test sequence in this arm is:
Coloplast Test b; Standard product; Coloplast Test A; Training + Coloplast Test B; Training + Coloplast Test A
Coloplast Test A: Coloplast Test A is a newly developed ostomy appliance
Coloplast Test B: Coloplast Test B is a newly developed ostomy appliance.
Standard product: Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation.
|
First Standard Product; Then Coloplast Test A
There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.
The test sequence in this arm is:
Standard product; Coloplast Test A; Coloplast Test B; ; Training + Coloplast Test A; Training + Coloplast Test B
Coloplast Test A: Coloplast Test A is a newly developed ostomy appliance
Coloplast Test B: Coloplast Test B is a newly developed ostomy appliance.
Standard product: Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation.
|
First Standard Product, Then Coloplast Test B
There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.
The test sequence in this arm is:
Standard product; Coloplast Test B; Coloplast Test A; ; Training + Coloplast Test B; Training + Coloplast Test A
Coloplast Test A: Coloplast Test A is a newly developed ostomy appliance
Coloplast Test B: Coloplast Test B is a newly developed ostomy appliance.
Standard product: Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation.
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Period 1
STARTED
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4
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3
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4
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3
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4
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4
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Period 1
COMPLETED
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4
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3
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4
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3
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4
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4
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Period 1
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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Period 2
STARTED
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4
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3
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4
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3
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4
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4
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Period 2
COMPLETED
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4
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3
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4
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3
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4
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4
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Period 2
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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Period 3
STARTED
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4
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3
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4
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3
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4
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4
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Period 3
COMPLETED
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4
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3
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4
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3
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4
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4
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Period 3
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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Period 4
STARTED
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4
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3
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4
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3
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4
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4
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Period 4
COMPLETED
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4
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3
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4
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3
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4
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4
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Period 4
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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Period 5
STARTED
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4
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3
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4
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3
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4
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4
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Period 5
COMPLETED
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2
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3
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3
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3
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4
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4
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Period 5
NOT COMPLETED
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2
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0
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1
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0
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0
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0
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Reasons for withdrawal
| Measure |
First Coloplast Teast A; Then Coloplast Test B
There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.
The test sequence in this arm is:
Coloplast Test A; Coloplast Test B; Standard product; Training + Coloplast Test A; Training + Coloplast Test B
Coloplast Test A: Coloplast Test A is a newly developed ostomy appliance
Coloplast Test B: Coloplast Test B is a newly developed ostomy appliance.
Standard product: Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation.
|
First Coloplast Test A; Then Standard Product
There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.
The test sequence in this arm is:
Coloplast Test A; Standard product; Coloplast Test B; ; Training + Coloplast Test A; Training + Coloplast Test B
Coloplast Test A: Coloplast Test A is a newly developed ostomy appliance
Coloplast Test B: Coloplast Test B is a newly developed ostomy appliance.
Standard product: Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation.
|
First Coloplast Test B; Then Colopast Test A
There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.
The test sequence in this arm is:
Coloplast Test B; Coloplast Test A; Standard product; Training + Coloplast Test B; Training + Coloplast Test A
Coloplast Test A: Coloplast Test A is a newly developed ostomy appliance
Coloplast Test B: Coloplast Test B is a newly developed ostomy appliance.
Standard product: Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation.
|
First Coloplast Test B; Then Standard Product
There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.
The test sequence in this arm is:
Coloplast Test b; Standard product; Coloplast Test A; Training + Coloplast Test B; Training + Coloplast Test A
Coloplast Test A: Coloplast Test A is a newly developed ostomy appliance
Coloplast Test B: Coloplast Test B is a newly developed ostomy appliance.
Standard product: Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation.
|
First Standard Product; Then Coloplast Test A
There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.
The test sequence in this arm is:
Standard product; Coloplast Test A; Coloplast Test B; ; Training + Coloplast Test A; Training + Coloplast Test B
Coloplast Test A: Coloplast Test A is a newly developed ostomy appliance
Coloplast Test B: Coloplast Test B is a newly developed ostomy appliance.
Standard product: Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation.
|
First Standard Product, Then Coloplast Test B
There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.
The test sequence in this arm is:
Standard product; Coloplast Test B; Coloplast Test A; ; Training + Coloplast Test B; Training + Coloplast Test A
Coloplast Test A: Coloplast Test A is a newly developed ostomy appliance
Coloplast Test B: Coloplast Test B is a newly developed ostomy appliance.
Standard product: Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation.
|
|---|---|---|---|---|---|---|
|
Period 5
Lack of Efficacy
|
1
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0
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0
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0
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0
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0
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Period 5
Adverse Event
|
1
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0
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1
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0
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0
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0
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Baseline Characteristics
The Influence of Baseplate Adhesive on the Degree of Leakage
Baseline characteristics by cohort
| Measure |
All Subjects
n=22 Participants
Baseline data is summarized for all subjects
|
|---|---|
|
Age, Continuous
|
67.0 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
22 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 (- 2 days)The primary endpoint was the degree of leakage under the baseplate, which was assessed using the three innermost rings of the 32-point leakage scale, corresponding to a total of 24 points (0 indicating no leakage and 24 indicating maximum leakage). Results are given separately for subjects with colostomy and ileostomy. In the ileostomy group there were no SenSura Mio participants in the standard care group.
Outcome measures
| Measure |
Colostomy ,Test A
n=16 Participants
|
Colostomy, Training + Test A
n=16 Participants
|
Colostomy, Test B
n=16 Participants
|
Colostomy, Training + Test B
n=15 Participants
|
Colostomy, Standard Care (SenSura Mio)
n=13 Participants
|
Colostomy, Standard Care (SenSura)
n=3 Participants
|
Ileostomy, Test A
n=6 Participants
|
Ileostomy, Training + Test A
n=5 Participants
|
Ileostomy, Test B
n=6 Participants
|
Ileostomy, Training + Test B
n=5 Participants
|
Ileostomy, Standard Care (SenSura)
n=6 Participants
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Degree of Leakage
|
3.6 units on a scale
Standard Deviation 5.0
|
2.4 units on a scale
Standard Deviation 4.2
|
5.5 units on a scale
Standard Deviation 5.5
|
4.8 units on a scale
Standard Deviation 5.1
|
3.7 units on a scale
Standard Deviation 6.5
|
3.3 units on a scale
Standard Deviation 3.2
|
9.1 units on a scale
Standard Deviation 5.2
|
9.7 units on a scale
Standard Deviation 5.7
|
11.5 units on a scale
Standard Deviation 5.3
|
12.9 units on a scale
Standard Deviation 5.6
|
8.5 units on a scale
Standard Deviation 5.1
|
Adverse Events
Test A + Training Test A
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Test B + Training Test B
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Standard Care
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Test A + Training Test A
n=22 participants at risk
Test Product A was used both during part one of the study (Test A) and part two (Training Test A) hence adverse events are reported collectively for Test Product A.
Consequently, Test Product A is used for two periods compared to Standard care which has been used for only one.
|
Test B + Training Test B
n=22 participants at risk
Test Product B was used both during part one of the study (Test B) and part two (Training Test B) hence adverse events are reported collectively for Test Product B.
Consequently, Test Product B is used for two periods compared to Standard care which has been used for only one.
|
Standard Care
n=22 participants at risk
Standard care was used only during part one of the study. i.e. for one period only.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Peristomal skin irritation/broken skin/stomal bleeding
|
27.3%
6/22 • Number of events 8 • Test A + Training Test A: Pooled data of Test A during part 1 and 2 of the study. Test B + Training Test B: Pooled data of Test B during part 1 and 2 of the study. Standard Care: Data from part 1 of the study only. No Adverse Events on SenSura.
|
40.9%
9/22 • Number of events 13 • Test A + Training Test A: Pooled data of Test A during part 1 and 2 of the study. Test B + Training Test B: Pooled data of Test B during part 1 and 2 of the study. Standard Care: Data from part 1 of the study only. No Adverse Events on SenSura.
|
4.5%
1/22 • Number of events 1 • Test A + Training Test A: Pooled data of Test A during part 1 and 2 of the study. Test B + Training Test B: Pooled data of Test B during part 1 and 2 of the study. Standard Care: Data from part 1 of the study only. No Adverse Events on SenSura.
|
|
Infections and infestations
Cold or influenza
|
9.1%
2/22 • Number of events 2 • Test A + Training Test A: Pooled data of Test A during part 1 and 2 of the study. Test B + Training Test B: Pooled data of Test B during part 1 and 2 of the study. Standard Care: Data from part 1 of the study only. No Adverse Events on SenSura.
|
0.00%
0/22 • Test A + Training Test A: Pooled data of Test A during part 1 and 2 of the study. Test B + Training Test B: Pooled data of Test B during part 1 and 2 of the study. Standard Care: Data from part 1 of the study only. No Adverse Events on SenSura.
|
4.5%
1/22 • Number of events 1 • Test A + Training Test A: Pooled data of Test A during part 1 and 2 of the study. Test B + Training Test B: Pooled data of Test B during part 1 and 2 of the study. Standard Care: Data from part 1 of the study only. No Adverse Events on SenSura.
|
|
Eye disorders
Planned operation, non-study related
|
0.00%
0/22 • Test A + Training Test A: Pooled data of Test A during part 1 and 2 of the study. Test B + Training Test B: Pooled data of Test B during part 1 and 2 of the study. Standard Care: Data from part 1 of the study only. No Adverse Events on SenSura.
|
0.00%
0/22 • Test A + Training Test A: Pooled data of Test A during part 1 and 2 of the study. Test B + Training Test B: Pooled data of Test B during part 1 and 2 of the study. Standard Care: Data from part 1 of the study only. No Adverse Events on SenSura.
|
4.5%
1/22 • Number of events 1 • Test A + Training Test A: Pooled data of Test A during part 1 and 2 of the study. Test B + Training Test B: Pooled data of Test B during part 1 and 2 of the study. Standard Care: Data from part 1 of the study only. No Adverse Events on SenSura.
|
|
Infections and infestations
Herpes Zoster
|
4.5%
1/22 • Number of events 1 • Test A + Training Test A: Pooled data of Test A during part 1 and 2 of the study. Test B + Training Test B: Pooled data of Test B during part 1 and 2 of the study. Standard Care: Data from part 1 of the study only. No Adverse Events on SenSura.
|
0.00%
0/22 • Test A + Training Test A: Pooled data of Test A during part 1 and 2 of the study. Test B + Training Test B: Pooled data of Test B during part 1 and 2 of the study. Standard Care: Data from part 1 of the study only. No Adverse Events on SenSura.
|
0.00%
0/22 • Test A + Training Test A: Pooled data of Test A during part 1 and 2 of the study. Test B + Training Test B: Pooled data of Test B during part 1 and 2 of the study. Standard Care: Data from part 1 of the study only. No Adverse Events on SenSura.
|
|
Gastrointestinal disorders
Diarrhea or constipation
|
4.5%
1/22 • Number of events 3 • Test A + Training Test A: Pooled data of Test A during part 1 and 2 of the study. Test B + Training Test B: Pooled data of Test B during part 1 and 2 of the study. Standard Care: Data from part 1 of the study only. No Adverse Events on SenSura.
|
0.00%
0/22 • Test A + Training Test A: Pooled data of Test A during part 1 and 2 of the study. Test B + Training Test B: Pooled data of Test B during part 1 and 2 of the study. Standard Care: Data from part 1 of the study only. No Adverse Events on SenSura.
|
0.00%
0/22 • Test A + Training Test A: Pooled data of Test A during part 1 and 2 of the study. Test B + Training Test B: Pooled data of Test B during part 1 and 2 of the study. Standard Care: Data from part 1 of the study only. No Adverse Events on SenSura.
|
|
Musculoskeletal and connective tissue disorders
Pain, leg
|
0.00%
0/22 • Test A + Training Test A: Pooled data of Test A during part 1 and 2 of the study. Test B + Training Test B: Pooled data of Test B during part 1 and 2 of the study. Standard Care: Data from part 1 of the study only. No Adverse Events on SenSura.
|
4.5%
1/22 • Number of events 1 • Test A + Training Test A: Pooled data of Test A during part 1 and 2 of the study. Test B + Training Test B: Pooled data of Test B during part 1 and 2 of the study. Standard Care: Data from part 1 of the study only. No Adverse Events on SenSura.
|
0.00%
0/22 • Test A + Training Test A: Pooled data of Test A during part 1 and 2 of the study. Test B + Training Test B: Pooled data of Test B during part 1 and 2 of the study. Standard Care: Data from part 1 of the study only. No Adverse Events on SenSura.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place