Trial Outcomes & Findings for Investigation of Two Newly Developed 2-piece Convex Baseplates in Subjects With Ileostomy (NCT NCT01957475)
NCT ID: NCT01957475
Last Updated: 2016-09-20
Results Overview
The degree of leakage is measured using a 32-point scale developed by Coloplast A/S, where 0 represents No leakage (best possible outcome) and 32 points represents full-plate leakage (worst possible outcome). The degree of leakage was measured at each baseplate change.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
14 days
Results posted on
2016-09-20
Participant Flow
The subjects were recruited through the danish Coloplast database.
Participant milestones
| Measure |
First Coloplast Test Product Z; Then Coloplast Test Product Y
The subjects first test Coloplast Test product Z and after cross-over Coloplast Test product Y
Coloplast Test product Y: Coloplast Test product Y is a newly developed 2-piece convex ostomy appliance
Coloplast Test product Z: Coloplast Test product Z is a newly developed 2-piece convex ostomy appliance
|
First Coloplast Test Product Y, Then Coloplast Test Product Z
The subjects first test test product Y and after cross-over test product Z
Coloplast Test product Y: Coloplast Test product Y is a newly developed 2-piece convex ostomy appliance
Coloplast Test product Z: Coloplast Test product Z is a newly developed 2-piece convex ostomy appliance
|
|---|---|---|
|
Test Period 1
STARTED
|
10
|
10
|
|
Test Period 1
COMPLETED
|
8
|
9
|
|
Test Period 1
NOT COMPLETED
|
2
|
1
|
|
Test Period 2
STARTED
|
9
|
8
|
|
Test Period 2
COMPLETED
|
8
|
8
|
|
Test Period 2
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
First Coloplast Test Product Z; Then Coloplast Test Product Y
The subjects first test Coloplast Test product Z and after cross-over Coloplast Test product Y
Coloplast Test product Y: Coloplast Test product Y is a newly developed 2-piece convex ostomy appliance
Coloplast Test product Z: Coloplast Test product Z is a newly developed 2-piece convex ostomy appliance
|
First Coloplast Test Product Y, Then Coloplast Test Product Z
The subjects first test test product Y and after cross-over test product Z
Coloplast Test product Y: Coloplast Test product Y is a newly developed 2-piece convex ostomy appliance
Coloplast Test product Z: Coloplast Test product Z is a newly developed 2-piece convex ostomy appliance
|
|---|---|---|
|
Test Period 1
Withdrawal by Subject
|
1
|
0
|
|
Test Period 1
Other
|
1
|
0
|
|
Test Period 1
Lack of Efficacy
|
0
|
1
|
|
Test Period 2
Adverse Event
|
1
|
0
|
Baseline Characteristics
Investigation of Two Newly Developed 2-piece Convex Baseplates in Subjects With Ileostomy
Baseline characteristics by cohort
| Measure |
All Subjects
n=20 Participants
|
|---|---|
|
Age, Continuous
|
60.8 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 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 (best possible outcome) and 32 points represents full-plate leakage (worst possible outcome). The degree of leakage was measured at each baseplate change.
Outcome measures
| Measure |
Test Y
n=112 baseplate
Results from the subjects testing Coloplast Test Y
|
Test Z
n=125 baseplate
Results from the subjects testing Coloplast Test Y
|
|---|---|---|
|
Degree of Leakage
|
5.0 units on a scale
Standard Deviation 5.3
|
5.6 units on a scale
Standard Deviation 5.7
|
Adverse Events
Test Y
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Test Z
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Test Y
n=18 participants at risk
Results from the subjects testing Coloplast Test Y
|
Test Z
n=19 participants at risk
Results from the subjects testing Coloplast Test Y
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Peristomal skin irritation
|
5.6%
1/18 • Number of events 1 • The subjects were enrolled for 28+/- 3 days
|
26.3%
5/19 • Number of events 5 • The subjects were enrolled for 28+/- 3 days
|
|
Skin and subcutaneous tissue disorders
Peristomal Itching
|
0.00%
0/18 • The subjects were enrolled for 28+/- 3 days
|
10.5%
2/19 • Number of events 2 • The subjects were enrolled for 28+/- 3 days
|
|
Skin and subcutaneous tissue disorders
Peristomal pain
|
5.6%
1/18 • Number of events 1 • The subjects were enrolled for 28+/- 3 days
|
5.3%
1/19 • Number of events 1 • The subjects were enrolled for 28+/- 3 days
|
|
Skin and subcutaneous tissue disorders
broken peristomal skin
|
5.6%
1/18 • Number of events 1 • The subjects were enrolled for 28+/- 3 days
|
5.3%
1/19 • Number of events 1 • The subjects were enrolled for 28+/- 3 days
|
|
Skin and subcutaneous tissue disorders
Pimple in peristomal area
|
5.6%
1/18 • Number of events 1 • The subjects were enrolled for 28+/- 3 days
|
0.00%
0/19 • The subjects were enrolled for 28+/- 3 days
|
|
Gastrointestinal disorders
Diarrhea
|
5.6%
1/18 • Number of events 1 • The subjects were enrolled for 28+/- 3 days
|
0.00%
0/19 • The subjects were enrolled for 28+/- 3 days
|
|
General disorders
Fainted
|
5.6%
1/18 • Number of events 1 • The subjects were enrolled for 28+/- 3 days
|
0.00%
0/19 • The subjects were enrolled for 28+/- 3 days
|
|
General disorders
Headache
|
5.6%
1/18 • Number of events 1 • The subjects were enrolled for 28+/- 3 days
|
0.00%
0/19 • The subjects were enrolled for 28+/- 3 days
|
|
General disorders
Nausea
|
5.6%
1/18 • Number of events 1 • The subjects were enrolled for 28+/- 3 days
|
0.00%
0/19 • The subjects were enrolled for 28+/- 3 days
|
|
Skin and subcutaneous tissue disorders
wound on right arm
|
5.6%
1/18 • Number of events 1 • The subjects were enrolled for 28+/- 3 days
|
0.00%
0/19 • The subjects were enrolled for 28+/- 3 days
|
|
Infections and infestations
Fungus infection in mouth
|
5.6%
1/18 • Number of events 1 • The subjects were enrolled for 28+/- 3 days
|
0.00%
0/19 • The subjects were enrolled for 28+/- 3 days
|
|
Gastrointestinal disorders
gastritis
|
5.6%
1/18 • Number of events 1 • The subjects were enrolled for 28+/- 3 days
|
0.00%
0/19 • The subjects were enrolled for 28+/- 3 days
|
|
Gastrointestinal disorders
Vomit
|
0.00%
0/18 • The subjects were enrolled for 28+/- 3 days
|
5.3%
1/19 • Number of events 1 • The subjects were enrolled for 28+/- 3 days
|
|
General disorders
chills in left side of bag and leg after applying the bag
|
0.00%
0/18 • The subjects were enrolled for 28+/- 3 days
|
5.3%
1/19 • Number of events 1 • The subjects were enrolled for 28+/- 3 days
|
|
Skin and subcutaneous tissue disorders
skin irritation on leg
|
0.00%
0/18 • The subjects were enrolled for 28+/- 3 days
|
5.3%
1/19 • Number of events 1 • The subjects were enrolled for 28+/- 3 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place