Trial Outcomes & Findings for Performance Study of Newly Developed Ostomy Products (NCT NCT01513330)
NCT ID: NCT01513330
Last Updated: 2014-01-09
Results Overview
Degree of leakage will be measured by a 25-point leakage scale (no leakage or up till 24 points of leakage), developed by Coloplast A/S. The subjects receive Petri dishes with pre-printed leakage scale on. The subject will place the Petri dish above the used baseplate and indicate where on the baseplate output appears. This is done by ticking of each area on the scale indicating the area of leakage.
COMPLETED
PHASE4
122 participants
14 days
2014-01-09
Participant Flow
The subjects were recruited via sites and user data-bases in Denmark, Norway, Germany and France.
Participant milestones
| Measure |
First SenSura Mio, Then Standard Care
The subjects first test SenSura Mio : Ostomy product - 1 piece closed bag and thereafter cross-over and test Standard Care (Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima)
|
First Standard Care, Then SenSura Mio
The subjects first test Standard Care Ostomy product 1 piece closed bags (Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima)and after cross-over test SenSura Mio 1-piece closed bags.
|
|---|---|---|
|
SenSura Mio First,
STARTED
|
64
|
58
|
|
SenSura Mio First,
COMPLETED
|
60
|
56
|
|
SenSura Mio First,
NOT COMPLETED
|
4
|
2
|
|
Standard Care First,
STARTED
|
60
|
56
|
|
Standard Care First,
COMPLETED
|
56
|
52
|
|
Standard Care First,
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
First SenSura Mio, Then Standard Care
The subjects first test SenSura Mio : Ostomy product - 1 piece closed bag and thereafter cross-over and test Standard Care (Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima)
|
First Standard Care, Then SenSura Mio
The subjects first test Standard Care Ostomy product 1 piece closed bags (Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima)and after cross-over test SenSura Mio 1-piece closed bags.
|
|---|---|---|
|
SenSura Mio First,
Adverse Event
|
2
|
0
|
|
SenSura Mio First,
Lack of Efficacy
|
0
|
1
|
|
SenSura Mio First,
Withdrawal by Subject
|
1
|
1
|
|
SenSura Mio First,
Other
|
1
|
0
|
|
Standard Care First,
Lack of Efficacy
|
2
|
2
|
|
Standard Care First,
Withdrawal by Subject
|
1
|
2
|
|
Standard Care First,
Other
|
1
|
0
|
Baseline Characteristics
Performance Study of Newly Developed Ostomy Products
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=122 Participants
Entire study population = all participants enrolled in the study
|
|---|---|
|
Age, Continuous
|
65.3 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
63 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 14 daysDegree of leakage will be measured by a 25-point leakage scale (no leakage or up till 24 points of leakage), developed by Coloplast A/S. The subjects receive Petri dishes with pre-printed leakage scale on. The subject will place the Petri dish above the used baseplate and indicate where on the baseplate output appears. This is done by ticking of each area on the scale indicating the area of leakage.
Outcome measures
| Measure |
SenSura Mio
n=2852 baseplates
SenSura Mio : Ostomy product - 1 piece closed bag
|
Standard Care
n=2810 baseplates
Standard Care : Ostomy product 1 piece closed bags. Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima.
|
|---|---|---|
|
Degree of Leakage. Each Baseplate Can Have a Score From 0-24 Points Were 0 is the Best Possible Outcome (No Leakage) and 24 Points is the Worst Possible Outcome (Full Plate Leakage)
|
3.8 points on a scale
Standard Deviation 5.0
|
3.4 points on a scale
Standard Deviation 4.4
|
Adverse Events
SenSura Mio
Standard Care
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SenSura Mio
n=120 participants at risk
SenSura Mio : Ostomy product - 1 piece closed bag
|
Standard Care
n=118 participants at risk
Standard Care : Ostomy product 1 piece closed bags. Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Itching
|
0.83%
1/120 • Number of events 1
|
0.85%
1/118 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Peristomal skin redness
|
1.7%
2/120 • Number of events 2
|
2.5%
3/118 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Peristomal skin erosion
|
0.83%
1/120 • Number of events 1
|
1.7%
2/118 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Peristomal allergic contact dermatitis
|
0.83%
1/120 • Number of events 1
|
0.85%
1/118 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Peristomal burns
|
0.83%
1/120 • Number of events 1
|
0.00%
0/118
|
|
Gastrointestinal disorders
Diarrhoea
|
0.83%
1/120 • Number of events 2
|
0.00%
0/118
|
|
Skin and subcutaneous tissue disorders
Infected toe
|
0.00%
0/120
|
0.85%
1/118 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Consumption of food leading to skin irritation
|
0.00%
0/120
|
0.85%
1/118 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Granulation in the peristomal area
|
1.7%
2/120 • Number of events 2
|
0.00%
0/118
|
|
Skin and subcutaneous tissue disorders
Pain in the peristomal area
|
0.83%
1/120 • Number of events 1
|
0.85%
1/118 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place