Trial Outcomes & Findings for A Clinical Investigation Evaluating Three New 1-piece Ostomy Products (NCT NCT03154944)
NCT ID: NCT03154944
Last Updated: 2025-03-28
Results Overview
The trans epidermal water loss is measured on the peristomal skin using a probe. The Tran epirdermal water loss is a maesure for the skins barrier function. There is always a loss of water from the skin due to natural evaporation. However, when the skin barrier is damaged the evaporation of water increases leading to a higher trans epidermal water loss. Thus, trans epidermal water loss is used to assess the damage to the skin. Measurements are in grams of water per square meter per hour (g/m\^2/h).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
38 participants
Primary outcome timeframe
7 days
Results posted on
2025-03-28
Participant Flow
Participant milestones
| Measure |
Ostomy Device 1
In this arm the subjects test a new ostomy device consisting of a known adhesive and a new top film
Ostomy device 1: This device consists of a known adhesive and a new top film
|
Ostomy Device 2
In this arm the subjects test a new ostomy device consisting of a new adhesive and a known top film
Ostomy device 2: This device consists of a new adhesive and a known top film
|
Ostomy Device 3
In this arm the subjects test a new ostomy device consisting of a known adhesive and a new top film
Ostomy device 3: This device consists of a known adhesive and a new top film
|
|---|---|---|---|
|
Overall Study
STARTED
|
13
|
15
|
10
|
|
Overall Study
COMPLETED
|
13
|
15
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Ostomy Device 1
n=13 Participants
In this arm the subjects test a new ostomy device consisting of a known adhesive and a new top film
|
Ostomy Device 2
n=15 Participants
In this arm the subjects test a new ostomy device consisting of a new adhesive and a known top film
|
Ostomy Device 3
n=10 Participants
In this arm the subjects test a new ostomy device consisting of a known adhesive and a new top film
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
70.1 years
STANDARD_DEVIATION 6.4 • n=13 Participants
|
70.1 years
STANDARD_DEVIATION 7.7 • n=15 Participants
|
63.6 years
STANDARD_DEVIATION 13 • n=10 Participants
|
68.4 years
STANDARD_DEVIATION 9.2 • n=38 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=13 Participants
|
2 Participants
n=15 Participants
|
3 Participants
n=10 Participants
|
7 Participants
n=38 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=13 Participants
|
13 Participants
n=15 Participants
|
7 Participants
n=10 Participants
|
31 Participants
n=38 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Denmark
|
13 participants
n=13 Participants
|
15 participants
n=15 Participants
|
10 participants
n=10 Participants
|
38 participants
n=38 Participants
|
PRIMARY outcome
Timeframe: 7 daysThe trans epidermal water loss is measured on the peristomal skin using a probe. The Tran epirdermal water loss is a maesure for the skins barrier function. There is always a loss of water from the skin due to natural evaporation. However, when the skin barrier is damaged the evaporation of water increases leading to a higher trans epidermal water loss. Thus, trans epidermal water loss is used to assess the damage to the skin. Measurements are in grams of water per square meter per hour (g/m\^2/h).
Outcome measures
| Measure |
Ostomy Device 1
n=13 Participants
In this arm the subjects test a new ostomy device consisting of a known adhesive and a new top film
Ostomy device 1: This device consists of a known adhesive and a new top film
|
Ostomy Device 2
n=15 Participants
In this arm the subjects test a new ostomy device consisting of a new adhesive and a known top film
Ostomy device 2: This device consists of a new adhesive and a known top film
|
Ostomy Device 3
n=10 Participants
In this arm the subjects test a new ostomy device consisting of a known adhesive and a new top film
Ostomy device 3: This device consists of a known adhesive and a new top film
|
|---|---|---|---|
|
Trans Epidermal Water Loss
|
19.6 g/m^2/h
Interval 15.5 to 24.9
|
20.7 g/m^2/h
Interval 16.6 to 25.8
|
24.1 g/m^2/h
Interval 18.2 to 31.8
|
Adverse Events
Ostomy Device 1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Ostomy Device 2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Ostomy Device 3
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ostomy Device 1
n=13 participants at risk
In this arm the subjects test a new ostomy device consisting of a known adhesive and a new top film
Ostomy device 1: This device consists of a known adhesive and a new top film
|
Ostomy Device 2
n=15 participants at risk
In this arm the subjects test a new ostomy device consisting of a new adhesive and a known top film
Ostomy device 2: This device consists of a new adhesive and a known top film
|
Ostomy Device 3
n=10 participants at risk
In this arm the subjects test a new ostomy device consisting of a known adhesive and a new top film
Ostomy device 3: This device consists of a known adhesive and a new top film
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Peristomal skin complications
|
15.4%
2/13 • Number of events 2 • 42 days
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research
|
6.7%
1/15 • Number of events 1 • 42 days
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research
|
10.0%
1/10 • Number of events 2 • 42 days
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place