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NCT03289013 Clinical Trial

Assessement of the Peal Force Needed to Peel New Adhesives From the Skin

Ileostomy - Stoma Clinical Trial

Official title:
A Pilot Evaluation Exploring New Adhesive Materials and Their Ability to Handle Moisture From Abdominal and Peristomal Skin

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03289013
Other study ID # CP267_02
Secondary ID
Status Completed
Phase N/A
First received September 18, 2017
Last updated January 31, 2018
Start date September 11, 2017
Est. completion date December 21, 2017

Study information
Verified date January 2018
Source Coloplast A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study investigates the adhesion of new adhesives to the skin.

Recruitment information / eligibility
Status Completed
Enrollment 5
Est. completion date December 21, 2017
Est. primary completion date December 21, 2017
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 investigation

Exclusion Criteria:

1. Currently receiving or have within the past 2 months received radio- and/or chemotherapy

2. Currently receiving or have within the past months received topical steroid treatment in the abdominal skin area or systemic steroid (tablet/injection) treatment.

3. Are pregnant or breastfeeding

4. Have dermatological problems in the abdominal area (assessed by investigator)

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Standard adhesive 1
This strip consists of a standard hydrocolloid adhesive found in ostomy devices
• Standard adhesive 2
This strip consists of a standard hydrocolloid adhesive found in ostomy devices
• LT-2
Newly developed adhesive
• LT-21
Newly developed adhesive
• LT-25
Newly developed adhesive
• 33-20
Newly developed adhesive

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 Swelling of the adhesive 1. Swelling of adhesive strips measured by weight (Difference between weight of strip before and after test) 21 days
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