Trial Outcomes & Findings for Evaluation of the Ability of Newly Developed Adhesives to Absorb Moisture (NCT NCT03619226)

NCT ID: NCT03619226

Last Updated: 2025-07-11

Results Overview

The outcome measure is described as number of events where the sensor system reacted to a false positive leak. Moisture in adhesive is measured using a sensor system. Moisture influences the resistance of the sensor system. Intense moisture/sweat does not result in false positive leak signals. The signal response to moisture/sweat is different to the response to leaks.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 6 participants
• Primary outcome timeframe: 3 days
• Results posted on: 2025-07-11

Participant Flow

Participant milestones

Measure	Test Patch (Adhesive Patch With Sensor System) + Hard Physical Activities + Normal Daily Activities Two adhesive patches are applied to the abdominal area on two consecutive days. The first patch is worn with normal daily activities and the second patch is stress tested during half an hour spinning activities in humid environment plus normal day activities.
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Test Patch n=6 Participants two adhesive patches are applied to the abdominal area test patch: the test patch consists of an adhesive patch
Age, Continuous	37 years STANDARD_DEVIATION 9 • n=6 Participants
Sex: Female, Male Female	6 Participants n=6 Participants
Sex: Female, Male Male	0 Participants n=6 Participants

PRIMARY outcome

Timeframe: 3 days

Population: Healthy volunteers

The outcome measure is described as number of events where the sensor system reacted to a false positive leak.

Moisture in adhesive is measured using a sensor system. Moisture influences the resistance of the sensor system. Intense moisture/sweat does not result in false positive leak signals. The signal response to moisture/sweat is different to the response to leaks.

Outcome measures

Measure	Test Patch (Adhesive Patch With Sensor System) + Normal Daily Activities n=6 Participants two adhesive patches are applied to the abdominal area on two consecutive days. The first patch is worn with normal daily activities and the second patch is stress tested during half an hour spinning activities in humid environment plus normal day activities.	Test Patch (Adhesive Patch With Sensor System) + Hard Physical Activities + Normal Daily Activities n=6 Participants two adhesive patches are applied to the abdominal area on two consecutive days. The first patch is worn with normal daily activities and the second patch is stress tested during half an hour spinning activities in humid environment plus normal day activities.
Resistance (Moisture in the Adhesive)	0 Number of false positive leaks	0 Number of false positive leaks

Adverse Events

Test Patch (Adhesive Patch With Sensor System) + Hard Physical Activities + Normal Daily Activities

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Julie Schnipper, Medical Writer

Coloplast A/S

Phone: 49111257

Email: dkjuls@coloplast.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place