Trial Outcomes & Findings for Assessment of New Enhanced Ostomy Device in Real-life Settings in Subjects Having a Stoma (NCT NCT03770078)

Last Updated: 2025-04-01

Results Overview

Trans epidermal water loss is an objective skin measurement that is measures the evaporation of water on the skin surface using a probe (DermaLab).The trans epidermal water loss is a measure for the skins barrier function. There is always a loss of water from the skin due to evaporation. When the skin barrier is damaged this evaporation of water increases. Thus, transepidermal water loss can be used to assess skin damage. Trans Epidermal Water Loss is reported in grams of water per square meter per hour (g/m\^2/h).

Recruitment status

COMPLETED

Study phase

Target enrollment

23 participants

Primary outcome timeframe

Four weeks

Results posted on

2025-04-01

Participant Flow

Participant milestones

Participant milestones
Measure	Baseline and Test Period The users tested a product for two weeks (baseline) and then went on to try the Test Product A for 28 days.
Overall Study STARTED	23
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Assessment of New Enhanced Ostomy Device in Real-life Settings in Subjects Having a Stoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Baseline and Test Period n=23 Participants The users tested a product for two weeks (baseline) and then went on to try the Test Product A for 28 days.
Age, Continuous	66.3 years STANDARD_DEVIATION 10.6 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	23 Participants n=5 Participants
Region of Enrollment Sweden	4 participants n=5 Participants
Region of Enrollment Denmark	19 participants n=5 Participants

PRIMARY outcome

Timeframe: Four weeks

Outcome measures

Outcome measures
Measure	Comparator Product n=23 Participants The users tested a product for two weeks (baseline)	Test Product A n=23 Participants Tested test product A for 28 days
Trans Epidermal Water Loss	39.0 g/m^2/h Interval 32.6 to 46.6	35.9 g/m^2/h Interval 30.1 to 42.7

Adverse Events

Baseline/Comparator Product

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Test Product A

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Baseline/Comparator Product n=23 participants at risk The users tested a product for two weeks (baseline)	Test Product A n=23 participants at risk Test Product A was used for 28 days.
Skin and subcutaneous tissue disorders Peristomal skin complications	13.0% 3/23 • Number of events 5 • 28 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	17.4% 4/23 • Number of events 7 • 28 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
Gastrointestinal disorders Swollen stoma	0.00% 0/23 • 28 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	4.3% 1/23 • Number of events 1 • 28 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
Gastrointestinal disorders Increased stoma mucous production	0.00% 0/23 • 28 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	4.3% 1/23 • Number of events 1 • 28 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

Head of Medical Writing and Biostatistics

Coloplast

Phone: 49113143

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place