Evaluation of the Ability of Newly Developed Adhesives to Absorb Moisture

Not Applicable

Completed

• Conditions: Stoma Ileostomy

• Registration Number: NCT03619226
• Lead Sponsor: Coloplast A/S

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-02
• Primary Completion: 2018-07-04
• Study Completion: 2018-07-04
• Study First Submitted: 2018-07-13
• Study First Submitted QC: 2018-08-06
• Study First Posted: 2018-08-07
• Results First Submitted: 2025-05-28
• Status Verified: 2025-06
• Results First Submitted QC: 2025-06-23
• Last Update Submitted: 2025-06-23
• Results First Posted: 2025-07-11
• Last Update Posted: 2025-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

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

Exclusion Criteria

1. Currently receiving or have within the past 2 month received radio- and/or chemo-therapy
2. Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
3. Are pregnant or breastfeeding
4. Having dermatological problems in the peristomal- or abdominal area (assessed by investigator)
5. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Resistance (Moisture in the Adhesive)	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.

Trial Locations

Locations (1)

Coloplast A/S; 🇩🇰 Humlebæk, Denmark