Trial Outcomes & Findings for Investigation of the Performance and Safety of New 1-piece Open Ostomy Appliances Compared to Standard Care (NCT NCT01957384)
NCT ID: NCT01957384
Last Updated: 2014-03-27
Results Overview
The degree of leakage was measured on a 24-point scale 0 (best possible outcome) to 24 (worst possible outcome) developed by Coloplast A/S
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
Up to 14 days per test product
Results posted on
2014-03-27
Participant Flow
The subjects were recruited through the Coloplast database in Denmark
25 subjects signed informed consent and were randomized. 2 subjects were screening failures and did not test any products. One subject violated an inclusion criterion (convex user). The subject tested both test products and is therefore included in the safety population. The 3 subjects are not included in the participant flow below.
Participant milestones
| Measure |
First Test Product 1, Then Test Product 2;Then Standard Care
The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods.
Subjects first testing Coloplast Test product 1 are randomised to secondly test :
\- Coloplast Test product 2
and thereafter
\- Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)and thereafter Coloplast Test product 2
|
First Test Product 1, Then Standard Care, Then Test Product 2
The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods.
Subjects first testing Coloplast Test product 1 are randomised to secondly test :
1\) Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)
and thereafter
1\) Coloplast Test product 2
|
First Test Product 2, Then Test Product 1, Then Standard Care
The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods.
Subjects first testing Coloplast Test product 2 are randomised to secondly test
1\) Coloplast Test product 1
and thereafter
1\) Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)
|
First Test Product 2; Then Standard Care, Then Test Product 1
The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods.
Subjects first testing Coloplast Test product 2 are randomised to secondly test :
1\) Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)
and thereafter
1\) Coloplast Test product 1
|
First Standard Care, Then Test Product 1, Then Test Product 2
The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods.
Subjects first testing Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)are randomised to secondly test
1\) Coloplast Test product 1
and thereafter
1\) Coloplast Test product 2
|
First Standard Care, Then Test Product 2, Then Test Product 1
The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods.
Subjects first testing Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)are randomised to secondly test
1\) Coloplast Test product 2
and thereafter
1\) Coloplast Test product 1
|
|---|---|---|---|---|---|---|
|
Test Period 1 (14 Days)
STARTED
|
4
|
4
|
4
|
4
|
3
|
3
|
|
Test Period 1 (14 Days)
COMPLETED
|
4
|
4
|
4
|
4
|
3
|
3
|
|
Test Period 1 (14 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Test Period 2 (14 Days)
STARTED
|
4
|
4
|
4
|
4
|
3
|
3
|
|
Test Period 2 (14 Days)
COMPLETED
|
4
|
4
|
4
|
4
|
3
|
3
|
|
Test Period 2 (14 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Test Period 3 (14 Days)
STARTED
|
4
|
4
|
4
|
4
|
3
|
3
|
|
Test Period 3 (14 Days)
COMPLETED
|
4
|
4
|
4
|
4
|
3
|
3
|
|
Test Period 3 (14 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Investigation of the Performance and Safety of New 1-piece Open Ostomy Appliances Compared to Standard Care
Baseline characteristics by cohort
| Measure |
All Subjects
n=24 Participants
|
|---|---|
|
Age, Continuous
|
28.4 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 14 days per test productThe degree of leakage was measured on a 24-point scale 0 (best possible outcome) to 24 (worst possible outcome) developed by Coloplast A/S
Outcome measures
| Measure |
Coloplast Test Product 1
n=148 baseplates
leakage data from all Test 1 baseplates
|
Coloplast Test Product 2
n=152 baseplates
Leakage data from all Test 2 baseplates
|
Standard Care
n=66 baseplates
leakage data from all Standard Care baseplates
|
|---|---|---|---|
|
Degree of Leakage
|
4 units on a scale
Standard Deviation 5
|
4.6 units on a scale
Standard Deviation 5.6
|
2.6 units on a scale
Standard Deviation 3.7
|
Adverse Events
Coloplast Test Product 1
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Coloplast Test Product 2
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Standard Care
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Coloplast Test Product 1
n=22 participants at risk
data from all subjects who tested Test 1 baseplates
|
Coloplast Test Product 2
n=22 participants at risk
data from all subjects who tested Test 2 baseplates
|
Standard Care
n=22 participants at risk
data from all subjects who tested Standard Care baseplates
|
|---|---|---|---|
|
Gastrointestinal disorders
Gastroenterit
|
4.5%
1/22 • Number of events 1
|
0.00%
0/22
|
0.00%
0/22
|
Other adverse events
| Measure |
Coloplast Test Product 1
n=22 participants at risk
data from all subjects who tested Test 1 baseplates
|
Coloplast Test Product 2
n=22 participants at risk
data from all subjects who tested Test 2 baseplates
|
Standard Care
n=22 participants at risk
data from all subjects who tested Standard Care baseplates
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Peristomal skin problem
|
13.6%
3/22 • Number of events 3
|
4.5%
1/22 • Number of events 1
|
0.00%
0/22
|
|
Skin and subcutaneous tissue disorders
Bleeding from stoma
|
0.00%
0/22
|
4.5%
1/22 • Number of events 1
|
0.00%
0/22
|
|
Infections and infestations
respirational tract infection
|
0.00%
0/22
|
4.5%
1/22 • Number of events 1
|
0.00%
0/22
|
|
Infections and infestations
infection of the operational wound on the back/ haemtom in operational wound
|
0.00%
0/22
|
4.5%
1/22 • Number of events 1
|
0.00%
0/22
|
|
Gastrointestinal disorders
Diarre
|
9.1%
2/22 • Number of events 2
|
4.5%
1/22 • Number of events 1
|
0.00%
0/22
|
|
Gastrointestinal disorders
inflammation in rectum
|
0.00%
0/22
|
0.00%
0/22
|
4.5%
1/22 • Number of events 1
|
|
General disorders
Pain in collapsed forefoot
|
0.00%
0/22
|
0.00%
0/22
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
Gastroenterit
|
0.00%
0/22
|
0.00%
0/22
|
4.5%
1/22 • Number of events 1
|
|
General disorders
short term dizziness
|
0.00%
0/22
|
4.5%
1/22 • Number of events 1
|
0.00%
0/22
|
|
Skin and subcutaneous tissue disorders
stinging skin around the stoma
|
0.00%
0/22
|
0.00%
0/22
|
4.5%
1/22 • Number of events 1
|
Additional Information
Marian Dyreborg Sinvani, Clinical Manager
Coloplast A/S
Phone: +45 4911 2356
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place