Trial Outcomes & Findings for Investigation of Two Newly Developed 1-piece Convex Baseplates in Subjects With Ileostomy and Colostomy (NCT NCT01957462)
NCT ID: NCT01957462
Last Updated: 2016-09-26
Results Overview
The degree of leakage is measured using a 32-point scale developed by Coloplast A/S, where 0 represents No leakage (the best possible outcome) and 32 points represents full plate leakage (worst possible outcome). The degree of leakage is measured at each baseplate change
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
31 participants
Primary outcome timeframe
14 days
Results posted on
2016-09-26
Participant Flow
Participant milestones
| Measure |
FirstColplast Test V, Then Coloplast Test X
The subject tests two experimental coloplast products in a randomised order. Coloplast Test product V and after cross over ColoplastTest product X
Coloplast Test V: Coloplast Test product V is a newly developed 1-piece ostomy appliance
Coloplast Test X: Coloplast Test X is a newly developed 1-piece ostomy appliance
|
First Coloplast Test X, Then Coloplast Test V
The subjects test the two experimental Coloplast products in a randomised order: Coloplast Test product X and after cross over Coloplast Test product V
Coloplast Test V: Coloplast Test product V is a newly developed 1-piece ostomy appliance
Coloplast Test X: Coloplast Test X is a newly developed 1-piece ostomy appliance
|
|---|---|---|
|
Test Period 1
STARTED
|
16
|
15
|
|
Test Period 1
COMPLETED
|
14
|
15
|
|
Test Period 1
NOT COMPLETED
|
2
|
0
|
|
Test Period 2
STARTED
|
14
|
15
|
|
Test Period 2
COMPLETED
|
14
|
15
|
|
Test Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
FirstColplast Test V, Then Coloplast Test X
The subject tests two experimental coloplast products in a randomised order. Coloplast Test product V and after cross over ColoplastTest product X
Coloplast Test V: Coloplast Test product V is a newly developed 1-piece ostomy appliance
Coloplast Test X: Coloplast Test X is a newly developed 1-piece ostomy appliance
|
First Coloplast Test X, Then Coloplast Test V
The subjects test the two experimental Coloplast products in a randomised order: Coloplast Test product X and after cross over Coloplast Test product V
Coloplast Test V: Coloplast Test product V is a newly developed 1-piece ostomy appliance
Coloplast Test X: Coloplast Test X is a newly developed 1-piece ostomy appliance
|
|---|---|---|
|
Test Period 1
Withdrawal by Subject
|
1
|
0
|
|
Test Period 1
Adverse Event
|
1
|
0
|
Baseline Characteristics
Investigation of Two Newly Developed 1-piece Convex Baseplates in Subjects With Ileostomy and Colostomy
Baseline characteristics by cohort
| Measure |
All Subjects
n=31 Participants
|
|---|---|
|
Age, Continuous
|
61.4 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 14 daysThe degree of leakage is measured using a 32-point scale developed by Coloplast A/S, where 0 represents No leakage (the best possible outcome) and 32 points represents full plate leakage (worst possible outcome). The degree of leakage is measured at each baseplate change
Outcome measures
| Measure |
Test V
n=357 baseplates
The results presented for the subjects testing Coloplast Test V
|
Test X
n=336 baseplates
the results presented for the subjects testing Test X
|
|---|---|---|
|
Degree of Leakage
|
3.5 units on a scale
Standard Deviation 5.0
|
3.1 units on a scale
Standard Deviation 5.1
|
Adverse Events
Test V
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Test X
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Test V
n=31 participants at risk
The results presented for the subjects testing Coloplast Test V
|
Test X
n=29 participants at risk
the results presented for the subjects testing Test X
|
|---|---|---|
|
Gastrointestinal disorders
constipation
|
0.00%
0/31 • 28+/- 3 days
|
3.4%
1/29 • Number of events 1 • 28+/- 3 days
|
|
Gastrointestinal disorders
Absess in the bowl ( by a fistel channel 2 mm from stoma)
|
3.2%
1/31 • Number of events 1 • 28+/- 3 days
|
0.00%
0/29 • 28+/- 3 days
|
Other adverse events
| Measure |
Test V
n=31 participants at risk
The results presented for the subjects testing Coloplast Test V
|
Test X
n=29 participants at risk
the results presented for the subjects testing Test X
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
peristomal skin irritation
|
22.6%
7/31 • Number of events 8 • 28+/- 3 days
|
24.1%
7/29 • Number of events 12 • 28+/- 3 days
|
|
Skin and subcutaneous tissue disorders
Peristomal Itching
|
16.1%
5/31 • Number of events 8 • 28+/- 3 days
|
3.4%
1/29 • Number of events 1 • 28+/- 3 days
|
|
Skin and subcutaneous tissue disorders
Peristomal skin Pain
|
0.00%
0/31 • 28+/- 3 days
|
3.4%
1/29 • Number of events 1 • 28+/- 3 days
|
|
Skin and subcutaneous tissue disorders
broken skin
|
3.2%
1/31 • Number of events 1 • 28+/- 3 days
|
0.00%
0/29 • 28+/- 3 days
|
|
Skin and subcutaneous tissue disorders
Petekkie/pressure mark (peristomal)
|
3.2%
1/31 • Number of events 1 • 28+/- 3 days
|
6.9%
2/29 • Number of events 4 • 28+/- 3 days
|
|
Gastrointestinal disorders
Pain and sorness by stoma and´in bowl
|
3.2%
1/31 • Number of events 1 • 28+/- 3 days
|
0.00%
0/29 • 28+/- 3 days
|
|
Gastrointestinal disorders
Obstipation
|
0.00%
0/31 • 28+/- 3 days
|
3.4%
1/29 • Number of events 1 • 28+/- 3 days
|
|
Metabolism and nutrition disorders
dehydration due to obstpation
|
0.00%
0/31 • 28+/- 3 days
|
3.4%
1/29 • Number of events 1 • 28+/- 3 days
|
|
General disorders
fatigue
|
0.00%
0/31 • 28+/- 3 days
|
3.4%
1/29 • Number of events 1 • 28+/- 3 days
|
|
Gastrointestinal disorders
Pain in bowl
|
3.2%
1/31 • Number of events 1 • 28+/- 3 days
|
0.00%
0/29 • 28+/- 3 days
|
|
Gastrointestinal disorders
Diarrhea
|
3.2%
1/31 • Number of events 1 • 28+/- 3 days
|
0.00%
0/29 • 28+/- 3 days
|
|
General disorders
Nausea
|
3.2%
1/31 • Number of events 1 • 28+/- 3 days
|
0.00%
0/29 • 28+/- 3 days
|
|
Infections and infestations
sore throat
|
0.00%
0/31 • 28+/- 3 days
|
3.4%
1/29 • Number of events 1 • 28+/- 3 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place