Trial Outcomes & Findings for A Clinical Investigation of New Ostomy Appliances (NCT NCT01523756)
NCT ID: NCT01523756
Last Updated: 2014-03-10
Results Overview
Leakage under the baseplate was measured with a 24 point scale where 0 points represents no leakage (best possible out come) and 24 points represents leakage on the whole plate (worst possible outcome)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
Each product will be tested 2 weeks
Results posted on
2014-03-10
Participant Flow
The subjects were recruited through the Coloplast database.
Participant milestones
| Measure |
Own Product (Baseline) - Test Product 1 - Test Product 2
own product (baseline) - test product 1 - test product 2
test product 1 = New ostomy base plate. Due to company confidentiality the product is just called test product 1
|
Own Product (Baseline) - Test Product 2 - Test Product 1
own product (baseline) - test product 2 - test product 1
test product 2 = New ostomy base plate. Due to company confidentiality the product is just called test product 2
|
|---|---|---|
|
Baseline Period
STARTED
|
11
|
9
|
|
Baseline Period
COMPLETED
|
11
|
8
|
|
Baseline Period
NOT COMPLETED
|
0
|
1
|
|
Test Period 1
STARTED
|
11
|
8
|
|
Test Period 1
COMPLETED
|
10
|
8
|
|
Test Period 1
NOT COMPLETED
|
1
|
0
|
|
Test Period 2
STARTED
|
10
|
8
|
|
Test Period 2
COMPLETED
|
10
|
7
|
|
Test Period 2
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Own Product (Baseline) - Test Product 1 - Test Product 2
own product (baseline) - test product 1 - test product 2
test product 1 = New ostomy base plate. Due to company confidentiality the product is just called test product 1
|
Own Product (Baseline) - Test Product 2 - Test Product 1
own product (baseline) - test product 2 - test product 1
test product 2 = New ostomy base plate. Due to company confidentiality the product is just called test product 2
|
|---|---|---|
|
Baseline Period
Adverse Event
|
0
|
1
|
|
Test Period 1
Adverse Event
|
1
|
0
|
|
Test Period 2
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
A Clinical Investigation of New Ostomy Appliances
Baseline characteristics by cohort
| Measure |
Overall Study
n=20 Participants
|
|---|---|
|
Age, Continuous
|
64 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Each product will be tested 2 weeksLeakage under the baseplate was measured with a 24 point scale where 0 points represents no leakage (best possible out come) and 24 points represents leakage on the whole plate (worst possible outcome)
Outcome measures
| Measure |
Test Product 1
n=111 degree of leakage on the baseplate
own product (baseline) - test product 1 - test product 2
test product 1 = New ostomy base plate. Due to company confidentiality the product is just called test product 1
|
Test Product 2
n=111 degree of leakage on the baseplate
own product (baseline) - test product 2 - test product 1
test product 2 = New ostomy base plate. Due to company confidentiality the product is just called test product 2
|
Baseline
n=113 degree of leakage on the baseplate
Data collected on own product-
All subjects collected baseline data on own product in the first period.
|
|---|---|---|---|
|
Leakage Under the Base Plate Using a 24-point Scale
|
4.5 units on a scale
Standard Deviation 5.3
|
3.3 units on a scale
Standard Deviation 4.3
|
4.4 units on a scale
Standard Deviation 4.7
|
Adverse Events
Test Product 1
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Test Product 2
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Baseline
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Test Product 1
n=19 participants at risk；n=20 participants at risk
own product (baseline) - test product 1 - test product 2
test product 1 = New ostomy base plate. Due to company confidentiality the product is just called test product 1
|
Test Product 2
n=18 participants at risk；n=20 participants at risk
own product (baseline) - test product 2 - test product 1
test product 2 = New ostomy base plate. Due to company confidentiality the product is just called test product 2
|
Baseline
n=20 participants at risk
Data collected on own product-
All subjects collected baseline data on own product in the first period.
|
|---|---|---|---|
|
Gastrointestinal disorders
Gastroenterit
|
0.00%
0/20
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
Other adverse events
| Measure |
Test Product 1
n=19 participants at risk；n=20 participants at risk
own product (baseline) - test product 1 - test product 2
test product 1 = New ostomy base plate. Due to company confidentiality the product is just called test product 1
|
Test Product 2
n=18 participants at risk；n=20 participants at risk
own product (baseline) - test product 2 - test product 1
test product 2 = New ostomy base plate. Due to company confidentiality the product is just called test product 2
|
Baseline
n=20 participants at risk
Data collected on own product-
All subjects collected baseline data on own product in the first period.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin irritation (peristomal)
|
15.8%
3/19 • Number of events 3
|
11.1%
2/18 • Number of events 2
|
0.00%
0/20
|
|
Skin and subcutaneous tissue disorders
Bleeding peristomal skin
|
0.00%
0/19
|
5.6%
1/18 • Number of events 1
|
0.00%
0/20
|
|
Skin and subcutaneous tissue disorders
Itchy peristomal skin
|
15.8%
3/19 • Number of events 3
|
5.6%
1/18 • Number of events 1
|
0.00%
0/20
|
|
Gastrointestinal disorders
Gastroenterit
|
0.00%
0/19
|
0.00%
0/18
|
5.0%
1/20 • Number of events 1
|
|
Renal and urinary disorders
Urin retension
|
0.00%
0/19
|
0.00%
0/18
|
5.0%
1/20 • Number of events 1
|
|
Renal and urinary disorders
Cystitis
|
5.3%
1/19 • Number of events 1
|
0.00%
0/18
|
5.0%
1/20 • Number of events 1
|
|
Infections and infestations
febrilia
|
0.00%
0/19
|
0.00%
0/18
|
5.0%
1/20 • Number of events 1
|
|
Renal and urinary disorders
pain in bladder/Tenesmi
|
0.00%
0/19
|
0.00%
0/18
|
5.0%
1/20 • Number of events 1
|
|
General disorders
Nausea
|
0.00%
0/19
|
0.00%
0/18
|
5.0%
1/20 • Number of events 1
|
|
Reproductive system and breast disorders
elevated prostataspecific antigen
|
0.00%
0/19
|
0.00%
0/18
|
5.0%
1/20 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
skin irritation
|
0.00%
0/19
|
0.00%
0/18
|
5.0%
1/20 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
cold
|
0.00%
0/19
|
11.1%
2/18 • Number of events 2
|
0.00%
0/20
|
|
Nervous system disorders
sclerose attack
|
5.3%
1/19 • Number of events 1
|
0.00%
0/18
|
0.00%
0/20
|
|
Infections and infestations
Herpes on the back of the thigh
|
5.3%
1/19 • Number of events 1
|
0.00%
0/18
|
0.00%
0/20
|
|
Infections and infestations
candidiacis on labia
|
5.3%
1/19 • Number of events 1
|
0.00%
0/18
|
0.00%
0/20
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place