Evaluation of the Ability of Newly Developed Adhesives to Absorb Moisture

Stoma Ileostomy Clinical Trial

Official title:

Evaluation of the Ability of Newly Developed Adhesives to Absorb Moisture

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03619226
• Other study ID #: CP284_1
• Status: Completed
• Phase: N/A
• Start date: July 2, 2018
• Est. completion date: July 4, 2018

Study information

• Verified date: August 2018
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: July 4, 2018
• Est. primary completion date: July 4, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stoma Ileostomy

Intervention

Other:
• test patch
the test patch consists of an adhesive patch

Locations

Country	Name	City	State
Denmark	Coloplast A/S	Humlebæk

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resistance (Moisture in the adhesive)	moisture in adhesive is measured using a measurement probe	3 days