Trial Outcomes & Findings for A Clinical Investigation Examining the Performance and Handling of New 2-piece Ostomy Products in 28 People With an Ileostomy. (NCT NCT02064231)
NCT ID: NCT02064231
Last Updated: 2020-09-10
Results Overview
Degree of leakage is measured on a 24 point scale where 0 represents no leakage (best possible outcome) and 24 represents leakage on the whole plate (worst possible outcome).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
28 participants
Primary outcome timeframe
14 days
Results posted on
2020-09-10
Participant Flow
The subject were recruited through the Danish Coloplast user data base.
28 subjects were randomized. However 2 subject were wrongly randomized. 1 subject was allocated to test Test D in the First period,1 subject First tested Test A followed by Test D. Two subject discontinued the testing of the new test products collected data on own product. These factors disturb the participant flow chart.
Participant milestones
| Measure |
Coloplast Test A, Coloplast Test B, Own Product
The subjects first test Coloplast Test A and thereafter Coloplast Test B and finally their own product for 14 days
Coloplast Test A: Coloplast Test A is a new ostomy appliance developed by Coloplast A/S
Coloplast Test B: Coloplast Test B is a newly developed ostomy appliance developed by Coloplast A/S
Own product: Own product is tested to get baseline results. Own product can be any 2-piece product that is commercially available. The manufactures can be Coloplast, Hollister, Convatec, Dansac, B. Braun and others.
|
Coloplast Test C , Coloplast Test D, Own Product
The subjects first test Coloplast Test C and thereafter Coloplast Test D and finally their own product for 14 days
Own product: Own product is tested to get baseline results. Own product can be any 2-piece product that is commercially available. The manufactures can be Coloplast, Hollister, Convatec, Dansac, B. Braun and others.
Coloplast Test C: Coloplast Test C is a new ostomy appliance developed by Coloplast A/S
Coloplast Test D: Coloplast Test D is a new ostomy appliance developed by Coloplast A/S
|
Coloplast Test D, Coloplast Test C, Own Product
The subjects first test Coloplast Test D and thereafter Coloplast Test C and finally their own product for 14 days
Coloplast Test D: Coloplast Test A is a new ostomy appliance developed by Coloplast A/S
Coloplast Test C: Coloplast Test B is a newly developed ostomy appliance developed by Coloplast A/S
Own product: Own product is tested to get baseline results. Own product can be any 2-piece product that is commercially available. The manufactures can be Coloplast, Hollister, Convatec, Dansac, B. Braun and others.
|
Oloplast Test A, Coloplast Test D, Own Product
The subjects first test Coloplast Test A and thereafter Coloplast Test D and finally their own product for 14 days
Coloplast Test A: Coloplast Test A is a new ostomy appliance developed by Coloplast A/S
Coloplast Test D: Coloplast Test D is a newly developed ostomy appliance developed by Coloplast A/S
Own product: Own product is tested to get baseline results. Own product can be any 2-piece product that is commercially available. The manufactures can be Coloplast, Hollister, Convatec, Dansac, B. Braun and others.
|
|---|---|---|---|---|
|
First Test Period (Test A or Test C)
STARTED
|
14
|
12
|
1
|
1
|
|
First Test Period (Test A or Test C)
COMPLETED
|
7
|
8
|
0
|
1
|
|
First Test Period (Test A or Test C)
NOT COMPLETED
|
7
|
4
|
1
|
0
|
|
Second Test Period (Test B or Test D)
STARTED
|
7
|
8
|
0
|
1
|
|
Second Test Period (Test B or Test D)
COMPLETED
|
6
|
7
|
0
|
1
|
|
Second Test Period (Test B or Test D)
NOT COMPLETED
|
1
|
1
|
0
|
0
|
|
Third Test Period (Own Product)
STARTED
|
8
|
8
|
0
|
1
|
|
Third Test Period (Own Product)
COMPLETED
|
8
|
8
|
0
|
1
|
|
Third Test Period (Own Product)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Coloplast Test A, Coloplast Test B, Own Product
The subjects first test Coloplast Test A and thereafter Coloplast Test B and finally their own product for 14 days
Coloplast Test A: Coloplast Test A is a new ostomy appliance developed by Coloplast A/S
Coloplast Test B: Coloplast Test B is a newly developed ostomy appliance developed by Coloplast A/S
Own product: Own product is tested to get baseline results. Own product can be any 2-piece product that is commercially available. The manufactures can be Coloplast, Hollister, Convatec, Dansac, B. Braun and others.
|
Coloplast Test C , Coloplast Test D, Own Product
The subjects first test Coloplast Test C and thereafter Coloplast Test D and finally their own product for 14 days
Own product: Own product is tested to get baseline results. Own product can be any 2-piece product that is commercially available. The manufactures can be Coloplast, Hollister, Convatec, Dansac, B. Braun and others.
Coloplast Test C: Coloplast Test C is a new ostomy appliance developed by Coloplast A/S
Coloplast Test D: Coloplast Test D is a new ostomy appliance developed by Coloplast A/S
|
Coloplast Test D, Coloplast Test C, Own Product
The subjects first test Coloplast Test D and thereafter Coloplast Test C and finally their own product for 14 days
Coloplast Test D: Coloplast Test A is a new ostomy appliance developed by Coloplast A/S
Coloplast Test C: Coloplast Test B is a newly developed ostomy appliance developed by Coloplast A/S
Own product: Own product is tested to get baseline results. Own product can be any 2-piece product that is commercially available. The manufactures can be Coloplast, Hollister, Convatec, Dansac, B. Braun and others.
|
Oloplast Test A, Coloplast Test D, Own Product
The subjects first test Coloplast Test A and thereafter Coloplast Test D and finally their own product for 14 days
Coloplast Test A: Coloplast Test A is a new ostomy appliance developed by Coloplast A/S
Coloplast Test D: Coloplast Test D is a newly developed ostomy appliance developed by Coloplast A/S
Own product: Own product is tested to get baseline results. Own product can be any 2-piece product that is commercially available. The manufactures can be Coloplast, Hollister, Convatec, Dansac, B. Braun and others.
|
|---|---|---|---|---|
|
First Test Period (Test A or Test C)
Lack of Efficacy
|
5
|
3
|
0
|
0
|
|
First Test Period (Test A or Test C)
Withdrawal by Subject
|
1
|
1
|
0
|
0
|
|
First Test Period (Test A or Test C)
Adverse Event
|
1
|
0
|
1
|
0
|
|
Second Test Period (Test B or Test D)
Lack of Efficacy
|
1
|
1
|
0
|
0
|
Baseline Characteristics
A Clinical Investigation Examining the Performance and Handling of New 2-piece Ostomy Products in 28 People With an Ileostomy.
Baseline characteristics by cohort
| Measure |
Overall Study Population
n=28 Participants
|
|---|---|
|
Age, Continuous
|
61.5 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 14 daysDegree of leakage is measured on a 24 point scale where 0 represents no leakage (best possible outcome) and 24 represents leakage on the whole plate (worst possible outcome).
Outcome measures
| Measure |
Coloplast Test A
n=85 baseplates
Subjects testing Test A
|
Coloplast Test B
n=43 baseplates
Subjects testing Test B
|
Coloplast Test C
n=72 baseplates
Subjects testing Test C
|
Coloplast Test D
n=61 baseplates
Subjects testing Test D
|
Own Product
n=87 baseplates
Subjects collecting data on own product
|
|---|---|---|---|---|---|
|
Degree of Leakage
|
6.4 units on a scale
Standard Deviation 5.5
|
3.4 units on a scale
Standard Deviation 4.2
|
7.0 units on a scale
Standard Deviation 4.7
|
7.0 units on a scale
Standard Deviation 4.0
|
1.9 units on a scale
Standard Deviation 3.1
|
Adverse Events
Coloplast Test A
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Coloplast Test B
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Coloplast Test C
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Coloplast Test D
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Own Product
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Coloplast Test A
n=15 participants at risk
Subjects testing Test A
|
Coloplast Test B
n=7 participants at risk
Subjects testing Test B
|
Coloplast Test C
n=12 participants at risk
Subjects testing Test C
|
Coloplast Test D
n=10 participants at risk
Subjects testing Test D
|
Own Product
n=16 participants at risk
Subjects collecting data on own product
|
|---|---|---|---|---|---|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/15
15 A=14 Coloplast TestA, Coloplast TestB..+1 Oloplast TestA, Coloplast TestD.. 7 B=7 Coloplast TestA, Coloplast TestB..(2nd period) 12 C=12 Coloplast TestC, Coloplast TestD.. 10 D=8 Coloplast TestC, Coloplast TestD..(2nd period)+1 Oloplast Test A, Coloplast Test D..(2nd period)+1 Coloplast Test D.. 16 own product=7 Coloplast Test A, Coloplast Test B..+8 Coloplast Test C, Coloplast Test D..+1 Oloplast Test A, Coloplast Test D..(incl. 2, not completing 2nd period, collecting own product data)
|
0.00%
0/7
15 A=14 Coloplast TestA, Coloplast TestB..+1 Oloplast TestA, Coloplast TestD.. 7 B=7 Coloplast TestA, Coloplast TestB..(2nd period) 12 C=12 Coloplast TestC, Coloplast TestD.. 10 D=8 Coloplast TestC, Coloplast TestD..(2nd period)+1 Oloplast Test A, Coloplast Test D..(2nd period)+1 Coloplast Test D.. 16 own product=7 Coloplast Test A, Coloplast Test B..+8 Coloplast Test C, Coloplast Test D..+1 Oloplast Test A, Coloplast Test D..(incl. 2, not completing 2nd period, collecting own product data)
|
0.00%
0/12
15 A=14 Coloplast TestA, Coloplast TestB..+1 Oloplast TestA, Coloplast TestD.. 7 B=7 Coloplast TestA, Coloplast TestB..(2nd period) 12 C=12 Coloplast TestC, Coloplast TestD.. 10 D=8 Coloplast TestC, Coloplast TestD..(2nd period)+1 Oloplast Test A, Coloplast Test D..(2nd period)+1 Coloplast Test D.. 16 own product=7 Coloplast Test A, Coloplast Test B..+8 Coloplast Test C, Coloplast Test D..+1 Oloplast Test A, Coloplast Test D..(incl. 2, not completing 2nd period, collecting own product data)
|
10.0%
1/10 • Number of events 1
15 A=14 Coloplast TestA, Coloplast TestB..+1 Oloplast TestA, Coloplast TestD.. 7 B=7 Coloplast TestA, Coloplast TestB..(2nd period) 12 C=12 Coloplast TestC, Coloplast TestD.. 10 D=8 Coloplast TestC, Coloplast TestD..(2nd period)+1 Oloplast Test A, Coloplast Test D..(2nd period)+1 Coloplast Test D.. 16 own product=7 Coloplast Test A, Coloplast Test B..+8 Coloplast Test C, Coloplast Test D..+1 Oloplast Test A, Coloplast Test D..(incl. 2, not completing 2nd period, collecting own product data)
|
0.00%
0/16
15 A=14 Coloplast TestA, Coloplast TestB..+1 Oloplast TestA, Coloplast TestD.. 7 B=7 Coloplast TestA, Coloplast TestB..(2nd period) 12 C=12 Coloplast TestC, Coloplast TestD.. 10 D=8 Coloplast TestC, Coloplast TestD..(2nd period)+1 Oloplast Test A, Coloplast Test D..(2nd period)+1 Coloplast Test D.. 16 own product=7 Coloplast Test A, Coloplast Test B..+8 Coloplast Test C, Coloplast Test D..+1 Oloplast Test A, Coloplast Test D..(incl. 2, not completing 2nd period, collecting own product data)
|
Other adverse events
| Measure |
Coloplast Test A
n=15 participants at risk
Subjects testing Test A
|
Coloplast Test B
n=7 participants at risk
Subjects testing Test B
|
Coloplast Test C
n=12 participants at risk
Subjects testing Test C
|
Coloplast Test D
n=10 participants at risk
Subjects testing Test D
|
Own Product
n=16 participants at risk
Subjects collecting data on own product
|
|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
peristomal skin problem
|
26.7%
4/15 • Number of events 5
15 A=14 Coloplast TestA, Coloplast TestB..+1 Oloplast TestA, Coloplast TestD.. 7 B=7 Coloplast TestA, Coloplast TestB..(2nd period) 12 C=12 Coloplast TestC, Coloplast TestD.. 10 D=8 Coloplast TestC, Coloplast TestD..(2nd period)+1 Oloplast Test A, Coloplast Test D..(2nd period)+1 Coloplast Test D.. 16 own product=7 Coloplast Test A, Coloplast Test B..+8 Coloplast Test C, Coloplast Test D..+1 Oloplast Test A, Coloplast Test D..(incl. 2, not completing 2nd period, collecting own product data)
|
0.00%
0/7
15 A=14 Coloplast TestA, Coloplast TestB..+1 Oloplast TestA, Coloplast TestD.. 7 B=7 Coloplast TestA, Coloplast TestB..(2nd period) 12 C=12 Coloplast TestC, Coloplast TestD.. 10 D=8 Coloplast TestC, Coloplast TestD..(2nd period)+1 Oloplast Test A, Coloplast Test D..(2nd period)+1 Coloplast Test D.. 16 own product=7 Coloplast Test A, Coloplast Test B..+8 Coloplast Test C, Coloplast Test D..+1 Oloplast Test A, Coloplast Test D..(incl. 2, not completing 2nd period, collecting own product data)
|
41.7%
5/12 • Number of events 6
15 A=14 Coloplast TestA, Coloplast TestB..+1 Oloplast TestA, Coloplast TestD.. 7 B=7 Coloplast TestA, Coloplast TestB..(2nd period) 12 C=12 Coloplast TestC, Coloplast TestD.. 10 D=8 Coloplast TestC, Coloplast TestD..(2nd period)+1 Oloplast Test A, Coloplast Test D..(2nd period)+1 Coloplast Test D.. 16 own product=7 Coloplast Test A, Coloplast Test B..+8 Coloplast Test C, Coloplast Test D..+1 Oloplast Test A, Coloplast Test D..(incl. 2, not completing 2nd period, collecting own product data)
|
30.0%
3/10 • Number of events 3
15 A=14 Coloplast TestA, Coloplast TestB..+1 Oloplast TestA, Coloplast TestD.. 7 B=7 Coloplast TestA, Coloplast TestB..(2nd period) 12 C=12 Coloplast TestC, Coloplast TestD.. 10 D=8 Coloplast TestC, Coloplast TestD..(2nd period)+1 Oloplast Test A, Coloplast Test D..(2nd period)+1 Coloplast Test D.. 16 own product=7 Coloplast Test A, Coloplast Test B..+8 Coloplast Test C, Coloplast Test D..+1 Oloplast Test A, Coloplast Test D..(incl. 2, not completing 2nd period, collecting own product data)
|
0.00%
0/16
15 A=14 Coloplast TestA, Coloplast TestB..+1 Oloplast TestA, Coloplast TestD.. 7 B=7 Coloplast TestA, Coloplast TestB..(2nd period) 12 C=12 Coloplast TestC, Coloplast TestD.. 10 D=8 Coloplast TestC, Coloplast TestD..(2nd period)+1 Oloplast Test A, Coloplast Test D..(2nd period)+1 Coloplast Test D.. 16 own product=7 Coloplast Test A, Coloplast Test B..+8 Coloplast Test C, Coloplast Test D..+1 Oloplast Test A, Coloplast Test D..(incl. 2, not completing 2nd period, collecting own product data)
|
|
Skin and subcutaneous tissue disorders
Wound peristomal skin
|
0.00%
0/15
15 A=14 Coloplast TestA, Coloplast TestB..+1 Oloplast TestA, Coloplast TestD.. 7 B=7 Coloplast TestA, Coloplast TestB..(2nd period) 12 C=12 Coloplast TestC, Coloplast TestD.. 10 D=8 Coloplast TestC, Coloplast TestD..(2nd period)+1 Oloplast Test A, Coloplast Test D..(2nd period)+1 Coloplast Test D.. 16 own product=7 Coloplast Test A, Coloplast Test B..+8 Coloplast Test C, Coloplast Test D..+1 Oloplast Test A, Coloplast Test D..(incl. 2, not completing 2nd period, collecting own product data)
|
0.00%
0/7
15 A=14 Coloplast TestA, Coloplast TestB..+1 Oloplast TestA, Coloplast TestD.. 7 B=7 Coloplast TestA, Coloplast TestB..(2nd period) 12 C=12 Coloplast TestC, Coloplast TestD.. 10 D=8 Coloplast TestC, Coloplast TestD..(2nd period)+1 Oloplast Test A, Coloplast Test D..(2nd period)+1 Coloplast Test D.. 16 own product=7 Coloplast Test A, Coloplast Test B..+8 Coloplast Test C, Coloplast Test D..+1 Oloplast Test A, Coloplast Test D..(incl. 2, not completing 2nd period, collecting own product data)
|
8.3%
1/12 • Number of events 1
15 A=14 Coloplast TestA, Coloplast TestB..+1 Oloplast TestA, Coloplast TestD.. 7 B=7 Coloplast TestA, Coloplast TestB..(2nd period) 12 C=12 Coloplast TestC, Coloplast TestD.. 10 D=8 Coloplast TestC, Coloplast TestD..(2nd period)+1 Oloplast Test A, Coloplast Test D..(2nd period)+1 Coloplast Test D.. 16 own product=7 Coloplast Test A, Coloplast Test B..+8 Coloplast Test C, Coloplast Test D..+1 Oloplast Test A, Coloplast Test D..(incl. 2, not completing 2nd period, collecting own product data)
|
0.00%
0/10
15 A=14 Coloplast TestA, Coloplast TestB..+1 Oloplast TestA, Coloplast TestD.. 7 B=7 Coloplast TestA, Coloplast TestB..(2nd period) 12 C=12 Coloplast TestC, Coloplast TestD.. 10 D=8 Coloplast TestC, Coloplast TestD..(2nd period)+1 Oloplast Test A, Coloplast Test D..(2nd period)+1 Coloplast Test D.. 16 own product=7 Coloplast Test A, Coloplast Test B..+8 Coloplast Test C, Coloplast Test D..+1 Oloplast Test A, Coloplast Test D..(incl. 2, not completing 2nd period, collecting own product data)
|
0.00%
0/16
15 A=14 Coloplast TestA, Coloplast TestB..+1 Oloplast TestA, Coloplast TestD.. 7 B=7 Coloplast TestA, Coloplast TestB..(2nd period) 12 C=12 Coloplast TestC, Coloplast TestD.. 10 D=8 Coloplast TestC, Coloplast TestD..(2nd period)+1 Oloplast Test A, Coloplast Test D..(2nd period)+1 Coloplast Test D.. 16 own product=7 Coloplast Test A, Coloplast Test B..+8 Coloplast Test C, Coloplast Test D..+1 Oloplast Test A, Coloplast Test D..(incl. 2, not completing 2nd period, collecting own product data)
|
|
Skin and subcutaneous tissue disorders
Itching peristomal skin
|
6.7%
1/15 • Number of events 1
15 A=14 Coloplast TestA, Coloplast TestB..+1 Oloplast TestA, Coloplast TestD.. 7 B=7 Coloplast TestA, Coloplast TestB..(2nd period) 12 C=12 Coloplast TestC, Coloplast TestD.. 10 D=8 Coloplast TestC, Coloplast TestD..(2nd period)+1 Oloplast Test A, Coloplast Test D..(2nd period)+1 Coloplast Test D.. 16 own product=7 Coloplast Test A, Coloplast Test B..+8 Coloplast Test C, Coloplast Test D..+1 Oloplast Test A, Coloplast Test D..(incl. 2, not completing 2nd period, collecting own product data)
|
0.00%
0/7
15 A=14 Coloplast TestA, Coloplast TestB..+1 Oloplast TestA, Coloplast TestD.. 7 B=7 Coloplast TestA, Coloplast TestB..(2nd period) 12 C=12 Coloplast TestC, Coloplast TestD.. 10 D=8 Coloplast TestC, Coloplast TestD..(2nd period)+1 Oloplast Test A, Coloplast Test D..(2nd period)+1 Coloplast Test D.. 16 own product=7 Coloplast Test A, Coloplast Test B..+8 Coloplast Test C, Coloplast Test D..+1 Oloplast Test A, Coloplast Test D..(incl. 2, not completing 2nd period, collecting own product data)
|
0.00%
0/12
15 A=14 Coloplast TestA, Coloplast TestB..+1 Oloplast TestA, Coloplast TestD.. 7 B=7 Coloplast TestA, Coloplast TestB..(2nd period) 12 C=12 Coloplast TestC, Coloplast TestD.. 10 D=8 Coloplast TestC, Coloplast TestD..(2nd period)+1 Oloplast Test A, Coloplast Test D..(2nd period)+1 Coloplast Test D.. 16 own product=7 Coloplast Test A, Coloplast Test B..+8 Coloplast Test C, Coloplast Test D..+1 Oloplast Test A, Coloplast Test D..(incl. 2, not completing 2nd period, collecting own product data)
|
0.00%
0/10
15 A=14 Coloplast TestA, Coloplast TestB..+1 Oloplast TestA, Coloplast TestD.. 7 B=7 Coloplast TestA, Coloplast TestB..(2nd period) 12 C=12 Coloplast TestC, Coloplast TestD.. 10 D=8 Coloplast TestC, Coloplast TestD..(2nd period)+1 Oloplast Test A, Coloplast Test D..(2nd period)+1 Coloplast Test D.. 16 own product=7 Coloplast Test A, Coloplast Test B..+8 Coloplast Test C, Coloplast Test D..+1 Oloplast Test A, Coloplast Test D..(incl. 2, not completing 2nd period, collecting own product data)
|
0.00%
0/16
15 A=14 Coloplast TestA, Coloplast TestB..+1 Oloplast TestA, Coloplast TestD.. 7 B=7 Coloplast TestA, Coloplast TestB..(2nd period) 12 C=12 Coloplast TestC, Coloplast TestD.. 10 D=8 Coloplast TestC, Coloplast TestD..(2nd period)+1 Oloplast Test A, Coloplast Test D..(2nd period)+1 Coloplast Test D.. 16 own product=7 Coloplast Test A, Coloplast Test B..+8 Coloplast Test C, Coloplast Test D..+1 Oloplast Test A, Coloplast Test D..(incl. 2, not completing 2nd period, collecting own product data)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place