Evaluation of the Ability of Newly Developed Adhesives to Absorb Moisture

NCT03619226 | Completed Results

• 1 other identifier: CP284_1
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stoma Ileostomy

Outcome Measures

Primary Outcomes (1)

• Resistance (Moisture in the Adhesive)

  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.

  3 days

Study Arms (1)

test patch

EXPERIMENTAL

two adhesive patches are applied to the abdominal area

Other: test patch

Interventions

test patch OTHER

the test patch consists of an adhesive patch

test patch

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (1)

Coloplast A/S

Humlebæk, 3050, Denmark

Location

MeSH Terms

Interventions

Patch Tests

Intervention Hierarchy (Ancestors)

Skin Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques

Results Point of Contact

• Title: Julie Schnipper, Medical Writer
• Organization: Coloplast A/S

dkjuls@coloplast.com

49111257

Study Officials

• Lene F Nielsen

  Head of the pre-clinical department

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2018
• First Posted: August 7, 2018
• Study Start: July 2, 2018
• Primary Completion: July 4, 2018
• Study Completion: July 4, 2018
• Last Updated: July 11, 2025
• Results First Posted: July 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)