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OpenTrials
Completed

NCT Number: NCT03619226

Evaluation of the Ability of Newly Developed Adhesives to Absorb Moisture

The aim of this evaluation is to investigate the ability of newly developed adhesive patches to absorb moisture.

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Key information

Conditions

Stoma Ileostomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Coloplast A/S

Humlebæk, 3050, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Have given written informed consent
  • Be at least 18 years of age and have full legal capacity
  • Have intact skin on the area used in the evaluation
  • Have an abdominal area accessible for application of test product (assessed by investigator)
  • Negative pregnancy test for fertile women
  • Signed document claiming use of safe contraceptives for fertile women

Exclusion criteria

  • Currently receiving or have within the past 2 month received radio- and/or chemo-therapy
  • Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
  • Are pregnant or breastfeeding
  • Having dermatological problems in the peristomal- or abdominal area (assessed by investigator)
  • Participating in interventional clinical investigations or have previously participated in this evaluation. Exception: Participation in other Coloplast sponsored clinical investigations or evaluations is accepted under the circumstances that the subject has paused the activities in the investigation/evaluation and are otherwise complying with the inclusion and exclusion criteria of this (CP284) Evaluation

Treatment and study plan

test patch

Other

the test patch consists of an adhesive patch

Primary outcomes

  1. Resistance (Moisture in the Adhesive)

    Time frame: 3 days

    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.

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 7, 2018
Registry last updated
Jul 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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