Trial Outcomes & Findings for Investigation of Newly Developed 1-piece Convex Baseplates in Subjects With Ileostomy (NCT NCT01994876)
NCT ID: NCT01994876
Last Updated: 2014-04-07
Results Overview
The degree of leakage was measured with a 32-point scale developed by Coloplast A/S, where 0 point represents the best possible outcome (no leakage) and 32 represents the worst possible outcome (full leakage under baseplate)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
18 participants
Primary outcome timeframe
14 days
Results posted on
2014-04-07
Participant Flow
The subject were recruited through the Coloplast database in The Netherlands
Participant milestones
| Measure |
First Coloplast Test 1, Then Coloplast Test 2
The subjects first test their own product to collect a baseline measurement
The subjects are randomised to first test Coloplast Test 1 and thereafter Coloplast Test 2
Coloplast Test 1: Coloplast Test 1 is a newly developed 1-piece convex ostomy appliance
Coloplast Test 2: Coloplast Test 2 is a newly developed 1-piece convex ostomy appliance
|
First Coloplast Test 2, Then Coloplast Test 1
The subjects first test their own product to collect baseline measurements
The subjects are randomised to first test Coloplast Test 2 and thereafter Coloplast Test 1
Coloplast Test 1: Coloplast Test 1 is a newly developed 1-piece convex ostomy appliance
Coloplast Test 2: Coloplast Test 2 is a newly developed 1-piece convex ostomy appliance
|
|---|---|---|
|
Baseline - Own Product
STARTED
|
9
|
9
|
|
Baseline - Own Product
COMPLETED
|
9
|
9
|
|
Baseline - Own Product
NOT COMPLETED
|
0
|
0
|
|
Test Period 1
STARTED
|
9
|
9
|
|
Test Period 1
COMPLETED
|
9
|
7
|
|
Test Period 1
NOT COMPLETED
|
0
|
2
|
|
Test Period 2
STARTED
|
9
|
7
|
|
Test Period 2
COMPLETED
|
8
|
6
|
|
Test Period 2
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
First Coloplast Test 1, Then Coloplast Test 2
The subjects first test their own product to collect a baseline measurement
The subjects are randomised to first test Coloplast Test 1 and thereafter Coloplast Test 2
Coloplast Test 1: Coloplast Test 1 is a newly developed 1-piece convex ostomy appliance
Coloplast Test 2: Coloplast Test 2 is a newly developed 1-piece convex ostomy appliance
|
First Coloplast Test 2, Then Coloplast Test 1
The subjects first test their own product to collect baseline measurements
The subjects are randomised to first test Coloplast Test 2 and thereafter Coloplast Test 1
Coloplast Test 1: Coloplast Test 1 is a newly developed 1-piece convex ostomy appliance
Coloplast Test 2: Coloplast Test 2 is a newly developed 1-piece convex ostomy appliance
|
|---|---|---|
|
Test Period 1
Withdrawal by Subject
|
0
|
1
|
|
Test Period 1
Adverse Event
|
0
|
1
|
|
Test Period 2
Adverse Event
|
1
|
0
|
|
Test Period 2
Protocol Violation
|
0
|
1
|
Baseline Characteristics
Investigation of Newly Developed 1-piece Convex Baseplates in Subjects With Ileostomy
Baseline characteristics by cohort
| Measure |
Overall Study
n=18 Participants
All the subjects in one group
|
|---|---|
|
Age, Continuous
|
54.4 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 14 daysThe degree of leakage was measured with a 32-point scale developed by Coloplast A/S, where 0 point represents the best possible outcome (no leakage) and 32 represents the worst possible outcome (full leakage under baseplate)
Outcome measures
| Measure |
Coloplast Test 1
n=229 baseplates
Results from subjects testing Coloplast Test 1
|
Coloplast Test 2
n=208 baseplates
Results from subjects testing Coloplast Test 2
|
Basline - Own Product
n=267 baseplates
Data from subject testing own product. Measures baseline leakage
|
|---|---|---|---|
|
Degree of Leakage
|
1.9 units on a scale
Standard Deviation 4.2
|
2.5 units on a scale
Standard Deviation 4.3
|
3.1 units on a scale
Standard Deviation 5.7
|
Adverse Events
Coloplast Test 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Coloplast Test 2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Basline - Own Product
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Coloplast Test 1
n=16 participants at risk
Results from subjects testing Coloplast Test 1
|
Coloplast Test 2
n=18 participants at risk
Results from subjects testing Coloplast Test 2
|
Basline - Own Product
n=18 participants at risk
Data from subject testing own product. Measures baseline leakage
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Redness skin
|
12.5%
2/16 • Number of events 2 • September - November 2012
|
0.00%
0/18 • September - November 2012
|
0.00%
0/18 • September - November 2012
|
|
Skin and subcutaneous tissue disorders
Peristomal skin irritaion
|
6.2%
1/16 • Number of events 1 • September - November 2012
|
0.00%
0/18 • September - November 2012
|
0.00%
0/18 • September - November 2012
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/16 • September - November 2012
|
5.6%
1/18 • Number of events 1 • September - November 2012
|
0.00%
0/18 • September - November 2012
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place