Trial Outcomes & Findings for Investigating the Safety and Performance of Two New 1-piece Ostomy Products Compared With SenSura 1-piece (NCT NCT01957488)
NCT ID: NCT01957488
Last Updated: 2020-09-10
Results Overview
The fraction of baseplates with No leakage/seeping under the baseplate was measured. Leakage/seeping under the baseplate was assessed after each baseplate change.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
183 participants
Primary outcome timeframe
14 +- 1 days
Results posted on
2020-09-10
Participant Flow
The subjects were recruited through the Coloplast database and hospital sites.
Participant milestones
| Measure |
SenSura/Test 1/Test 2
The subjects in this group test the following in the order described below:
1. SenSura (the comparator)
2. Test 1
3. Test 2
The products are single use products which in average are removed and re-applyed every1-2nd day.
|
SenSura/Test 2/Test 1
The subjects in this group test the following in the order described below:
1. SenSura (the comparator)
2. Test 2
3. Test 1
The products are single use products which in average are removed and re-applyed every1-2nd day.
|
Test 1/SenSura/Test 2
The subjects in this group test the following in the order described below:
1. Test 1
2. SenSura (the comparator)
3. Test 2
The products are single use products which in average are removed and re-applyed every1-2nd day.
|
Test 1/Test 2/SenSura
The subjects in this group test the following in the order described below:
1. Test 1
2. Test 2
3. SenSura (the comparator)
The products are single use products which in average are removed and re-applyed every1-2nd day.
|
Test 2/SenSura/Test 1
The subjects in this group test the following in the order described below:
1. Test 2
2. SenSura (the comparator)
3. Test 1
The products are single use products which in average are removed and re-applyed every1-2nd day.
|
Test 2/Test 1/SenSura
The subjects in this group test the following in the order described below:
1. Test 2
2. Test 1
3. SenSura (the comparator)
The products are single use products which in average are removed and re-applyed every1-2nd day.
|
|---|---|---|---|---|---|---|
|
Test Period 1 (2 Weeks)
STARTED
|
30
|
31
|
30
|
32
|
30
|
30
|
|
Test Period 1 (2 Weeks)
COMPLETED
|
27
|
28
|
26
|
29
|
27
|
24
|
|
Test Period 1 (2 Weeks)
NOT COMPLETED
|
3
|
3
|
4
|
3
|
3
|
6
|
|
Test Period 2 (2 Weeks)
STARTED
|
27
|
28
|
26
|
29
|
27
|
24
|
|
Test Period 2 (2 Weeks)
COMPLETED
|
24
|
27
|
25
|
28
|
25
|
23
|
|
Test Period 2 (2 Weeks)
NOT COMPLETED
|
3
|
1
|
1
|
1
|
2
|
1
|
|
Test Period 3 (2 Weeks)
STARTED
|
24
|
27
|
25
|
28
|
25
|
23
|
|
Test Period 3 (2 Weeks)
COMPLETED
|
23
|
26
|
25
|
28
|
25
|
23
|
|
Test Period 3 (2 Weeks)
NOT COMPLETED
|
1
|
1
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
SenSura/Test 1/Test 2
The subjects in this group test the following in the order described below:
1. SenSura (the comparator)
2. Test 1
3. Test 2
The products are single use products which in average are removed and re-applyed every1-2nd day.
|
SenSura/Test 2/Test 1
The subjects in this group test the following in the order described below:
1. SenSura (the comparator)
2. Test 2
3. Test 1
The products are single use products which in average are removed and re-applyed every1-2nd day.
|
Test 1/SenSura/Test 2
The subjects in this group test the following in the order described below:
1. Test 1
2. SenSura (the comparator)
3. Test 2
The products are single use products which in average are removed and re-applyed every1-2nd day.
|
Test 1/Test 2/SenSura
The subjects in this group test the following in the order described below:
1. Test 1
2. Test 2
3. SenSura (the comparator)
The products are single use products which in average are removed and re-applyed every1-2nd day.
|
Test 2/SenSura/Test 1
The subjects in this group test the following in the order described below:
1. Test 2
2. SenSura (the comparator)
3. Test 1
The products are single use products which in average are removed and re-applyed every1-2nd day.
|
Test 2/Test 1/SenSura
The subjects in this group test the following in the order described below:
1. Test 2
2. Test 1
3. SenSura (the comparator)
The products are single use products which in average are removed and re-applyed every1-2nd day.
|
|---|---|---|---|---|---|---|
|
Test Period 1 (2 Weeks)
Lost to Follow-up
|
2
|
0
|
1
|
1
|
0
|
0
|
|
Test Period 1 (2 Weeks)
Protocol Violation
|
1
|
2
|
2
|
1
|
0
|
3
|
|
Test Period 1 (2 Weeks)
Adverse Event
|
0
|
1
|
1
|
0
|
1
|
0
|
|
Test Period 1 (2 Weeks)
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
1
|
2
|
|
Test Period 1 (2 Weeks)
subject did not want to wait for cut bag
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Test Period 1 (2 Weeks)
screen failure
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Test Period 2 (2 Weeks)
Protocol Violation
|
2
|
0
|
1
|
1
|
0
|
0
|
|
Test Period 2 (2 Weeks)
Other
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Test Period 2 (2 Weeks)
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Test Period 2 (2 Weeks)
Adverse Event
|
0
|
0
|
0
|
0
|
2
|
0
|
|
Test Period 2 (2 Weeks)
Discontinue due to personal problems
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Test Period 3 (2 Weeks)
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Test Period 3 (2 Weeks)
Lack of Efficacy
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Investigating the Safety and Performance of Two New 1-piece Ostomy Products Compared With SenSura 1-piece
Baseline characteristics by cohort
| Measure |
All Subjects
n=174 Participants
|
|---|---|
|
Age, Continuous
|
57 years
STANDARD_DEVIATION 11.4 • n=99 Participants
|
|
Sex: Female, Male
Female
|
71 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
103 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 14 +- 1 daysThe fraction of baseplates with No leakage/seeping under the baseplate was measured. Leakage/seeping under the baseplate was assessed after each baseplate change.
Outcome measures
| Measure |
Test 1
n=1867 baseplates
Fraction of baseplates with No leakage/seeping under the baseplate for subjects testing Coloplast Test 1
|
Test 2
n=1907 baseplates
Fraction of baseplates with No leakage/seeping under the baseplate for subjects testing Coloplast Test 2
|
SenSura
n=1933 baseplates
Fraction of baseplates with No leakage/Seeping under the baseplate for subjects testing SenSura
|
|---|---|---|---|
|
Leakage
|
50 percentage of baseplates
|
61 percentage of baseplates
|
59 percentage of baseplates
|
Adverse Events
Test 1
Serious events: 3 serious events
Other events: 38 other events
Deaths: 0 deaths
Test 2
Serious events: 2 serious events
Other events: 24 other events
Deaths: 0 deaths
SenSura
Serious events: 5 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Test 1
n=162 participants at risk
Subjects testing Coloplast Test 1
|
Test 2
n=163 participants at risk
Subjects testing Coloplast Test 2
|
SenSura
n=163 participants at risk
Subjects testing SenSura
|
|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.62%
1/162 • Number of events 1 • Adverse event data was collected during each test period 2 weeks +- 1 day
|
0.00%
0/163 • Adverse event data was collected during each test period 2 weeks +- 1 day
|
0.00%
0/163 • Adverse event data was collected during each test period 2 weeks +- 1 day
|
|
Metabolism and nutrition disorders
Dehydration
|
0.62%
1/162 • Number of events 1 • Adverse event data was collected during each test period 2 weeks +- 1 day
|
0.00%
0/163 • Adverse event data was collected during each test period 2 weeks +- 1 day
|
0.00%
0/163 • Adverse event data was collected during each test period 2 weeks +- 1 day
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/162 • Adverse event data was collected during each test period 2 weeks +- 1 day
|
0.00%
0/163 • Adverse event data was collected during each test period 2 weeks +- 1 day
|
0.61%
1/163 • Number of events 1 • Adverse event data was collected during each test period 2 weeks +- 1 day
|
|
Infections and infestations
Superficial Abscess - surcically drained
|
0.00%
0/162 • Adverse event data was collected during each test period 2 weeks +- 1 day
|
0.61%
1/163 • Number of events 1 • Adverse event data was collected during each test period 2 weeks +- 1 day
|
0.00%
0/163 • Adverse event data was collected during each test period 2 weeks +- 1 day
|
|
Infections and infestations
Dehydration after abdominal infection
|
0.00%
0/162 • Adverse event data was collected during each test period 2 weeks +- 1 day
|
0.61%
1/163 • Number of events 1 • Adverse event data was collected during each test period 2 weeks +- 1 day
|
0.00%
0/163 • Adverse event data was collected during each test period 2 weeks +- 1 day
|
|
Renal and urinary disorders
Nephrolitiasis
|
0.00%
0/162 • Adverse event data was collected during each test period 2 weeks +- 1 day
|
0.00%
0/163 • Adverse event data was collected during each test period 2 weeks +- 1 day
|
0.61%
1/163 • Number of events 1 • Adverse event data was collected during each test period 2 weeks +- 1 day
|
|
Gastrointestinal disorders
AC Ileus
|
0.62%
1/162 • Number of events 1 • Adverse event data was collected during each test period 2 weeks +- 1 day
|
0.00%
0/163 • Adverse event data was collected during each test period 2 weeks +- 1 day
|
0.00%
0/163 • Adverse event data was collected during each test period 2 weeks +- 1 day
|
|
Gastrointestinal disorders
Blocked Stoma
|
0.62%
1/162 • Number of events 1 • Adverse event data was collected during each test period 2 weeks +- 1 day
|
0.00%
0/163 • Adverse event data was collected during each test period 2 weeks +- 1 day
|
0.00%
0/163 • Adverse event data was collected during each test period 2 weeks +- 1 day
|
|
Respiratory, thoracic and mediastinal disorders
Lung Cancer Complication
|
0.00%
0/162 • Adverse event data was collected during each test period 2 weeks +- 1 day
|
0.00%
0/163 • Adverse event data was collected during each test period 2 weeks +- 1 day
|
0.61%
1/163 • Number of events 1 • Adverse event data was collected during each test period 2 weeks +- 1 day
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/162 • Adverse event data was collected during each test period 2 weeks +- 1 day
|
0.00%
0/163 • Adverse event data was collected during each test period 2 weeks +- 1 day
|
0.61%
1/163 • Number of events 1 • Adverse event data was collected during each test period 2 weeks +- 1 day
|
|
Social circumstances
Lacerations left hand requiring suturs following dog attack
|
0.00%
0/162 • Adverse event data was collected during each test period 2 weeks +- 1 day
|
0.00%
0/163 • Adverse event data was collected during each test period 2 weeks +- 1 day
|
0.61%
1/163 • Number of events 1 • Adverse event data was collected during each test period 2 weeks +- 1 day
|
Other adverse events
| Measure |
Test 1
n=162 participants at risk
Subjects testing Coloplast Test 1
|
Test 2
n=163 participants at risk
Subjects testing Coloplast Test 2
|
SenSura
n=163 participants at risk
Subjects testing SenSura
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
23.5%
38/162 • Number of events 54 • Adverse event data was collected during each test period 2 weeks +- 1 day
|
14.7%
24/163 • Number of events 39 • Adverse event data was collected during each test period 2 weeks +- 1 day
|
16.6%
27/163 • Number of events 36 • Adverse event data was collected during each test period 2 weeks +- 1 day
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place