Trial Outcomes & Findings for Investigation of a New 2-piece Ostomy Product in People With an Ileostomy or Colostomy (NCT NCT02362360)
NCT ID: NCT02362360
Last Updated: 2016-10-11
Results Overview
Subjects will evaluate the fit to body for each product by answering the question "How was the baseplates ability to fit to the body contours in the area around the stoma?". The question is answered with a 5-point scale ranging from "very poor" to "very good".
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
52 participants
Primary outcome timeframe
21 +/- 3 days
Results posted on
2016-10-11
Participant Flow
One subject was a screen failure and was not exposed to any of the test products. This subject was excluded from the safety population, which therefore included 52 subjects.
Participant milestones
| Measure |
Coloplast Test Product Then Comparator
The subject first tests the Coloplast Test Product and then tests the Comparator
Coloplast Test Product: A new 2-piece ostomy appliance developed by Coloplast A/S
Comparator (Hollister): Comparator is a Hollister FlexWear baseplate (ileostomy) or a Hollister SoftFlex baseplate (colostomy) both used with a Hollister open bag.
|
Comparator Then Coloplast Test Product
The subject first tests the Comparator and then tests the Coloplast Test Product.
Coloplast Test Product: A new 2-piece ostomy appliance developed by Coloplast A/S
Comparator (Hollister): Comparator is a Hollister FlexWear baseplate (ileostomy) or a Hollister SoftFlex baseplate (colostomy) both used with a Hollister open bag.
|
|---|---|---|
|
Period 1
STARTED
|
26
|
26
|
|
Period 1
COMPLETED
|
23
|
25
|
|
Period 1
NOT COMPLETED
|
3
|
1
|
|
Period 2
STARTED
|
23
|
25
|
|
Period 2
COMPLETED
|
23
|
25
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Coloplast Test Product Then Comparator
The subject first tests the Coloplast Test Product and then tests the Comparator
Coloplast Test Product: A new 2-piece ostomy appliance developed by Coloplast A/S
Comparator (Hollister): Comparator is a Hollister FlexWear baseplate (ileostomy) or a Hollister SoftFlex baseplate (colostomy) both used with a Hollister open bag.
|
Comparator Then Coloplast Test Product
The subject first tests the Comparator and then tests the Coloplast Test Product.
Coloplast Test Product: A new 2-piece ostomy appliance developed by Coloplast A/S
Comparator (Hollister): Comparator is a Hollister FlexWear baseplate (ileostomy) or a Hollister SoftFlex baseplate (colostomy) both used with a Hollister open bag.
|
|---|---|---|
|
Period 1
Lack of Efficacy
|
1
|
0
|
|
Period 1
Withdrawal by Subject
|
2
|
1
|
Baseline Characteristics
Investigation of a New 2-piece Ostomy Product in People With an Ileostomy or Colostomy
Baseline characteristics by cohort
| Measure |
Overall Study Population
n=52 Participants
All subjects included in the investigation
|
|---|---|
|
Age, Continuous
|
70.9 years
STANDARD_DEVIATION 9.5 • n=99 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 21 +/- 3 daysSubjects will evaluate the fit to body for each product by answering the question "How was the baseplates ability to fit to the body contours in the area around the stoma?". The question is answered with a 5-point scale ranging from "very poor" to "very good".
Outcome measures
| Measure |
Coloplast Test Product
n=51 Participants
Answers from subjects testing Coloplast test product
|
Comparator
n=49 Participants
Answers from subjects testing Comparator
|
|---|---|---|
|
Fit to the Peristomal Area, Measured by a 5-point Scale Ranging From "Very Poor" to "Very Good".
Very good
|
56.9 percentage of subjects answering
|
10.6 percentage of subjects answering
|
|
Fit to the Peristomal Area, Measured by a 5-point Scale Ranging From "Very Poor" to "Very Good".
Good
|
29.4 percentage of subjects answering
|
27.7 percentage of subjects answering
|
|
Fit to the Peristomal Area, Measured by a 5-point Scale Ranging From "Very Poor" to "Very Good".
Acceptable
|
9.8 percentage of subjects answering
|
42.6 percentage of subjects answering
|
|
Fit to the Peristomal Area, Measured by a 5-point Scale Ranging From "Very Poor" to "Very Good".
Poor
|
3.9 percentage of subjects answering
|
19.1 percentage of subjects answering
|
|
Fit to the Peristomal Area, Measured by a 5-point Scale Ranging From "Very Poor" to "Very Good".
Very poor
|
0 percentage of subjects answering
|
0 percentage of subjects answering
|
Adverse Events
Coloplast Test Product
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Comparator
Serious events: 3 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Coloplast Test Product
n=51 participants at risk
Answers from subjects testing Coloplast test product
|
Comparator
n=49 participants at risk
Answers from subjects testing Comparator
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Lung infection
|
0.00%
0/51 • Adverse events were collected during the study period: 42 days +/- 6 days
|
2.0%
1/49 • Number of events 1 • Adverse events were collected during the study period: 42 days +/- 6 days
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome in left lower leg
|
0.00%
0/51 • Adverse events were collected during the study period: 42 days +/- 6 days
|
2.0%
1/49 • Number of events 1 • Adverse events were collected during the study period: 42 days +/- 6 days
|
|
Renal and urinary disorders
Acute renal failure
|
0.00%
0/51 • Adverse events were collected during the study period: 42 days +/- 6 days
|
2.0%
1/49 • Number of events 1 • Adverse events were collected during the study period: 42 days +/- 6 days
|
Other adverse events
| Measure |
Coloplast Test Product
n=51 participants at risk
Answers from subjects testing Coloplast test product
|
Comparator
n=49 participants at risk
Answers from subjects testing Comparator
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
17.6%
9/51 • Number of events 14 • Adverse events were collected during the study period: 42 days +/- 6 days
|
34.7%
17/49 • Number of events 21 • Adverse events were collected during the study period: 42 days +/- 6 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60