Assessement of the Peal Force Needed to Peel New Adhesives From the Skin
A Pilot Evaluation Exploring New Adhesive Materials and Their Ability to Handle Moisture From Abdominal and Peristomal Skin
1 other identifier
interventional
5
1 country
1
Brief Summary
This study investigates the adhesion of new adhesives to the skin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 11, 2017
CompletedFirst Submitted
Initial submission to the registry
September 18, 2017
CompletedFirst Posted
Study publicly available on registry
September 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 21, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 21, 2017
CompletedFebruary 1, 2018
January 1, 2018
3 months
September 18, 2017
January 31, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Swelling of the adhesive
1\. Swelling of adhesive strips measured by weight (Difference between weight of strip before and after test)
21 days
Study Arms (1)
Testing of new adhesive strips
EXPERIMENTALEach subject will test six adhesive strips on pre-stripped skin. 1. Standard adhesive 1 2. Standard adhesive 2 3. LT-2 4. LT-21 5. LT-25 6. 33-20 The six strips are applied on the abdominal skin. The order of the adhesive strips on the skin is randomized. The subjects will change the adhesive strips at home and the adhesion of adhesive strips will be measured at 5 visits.
Interventions
This strip consists of a standard hydrocolloid adhesive found in ostomy devices
This strip consists of a standard hydrocolloid adhesive found in ostomy devices
Eligibility Criteria
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 investigation
You may not qualify if:
- Currently receiving or have within the past 2 months received radio- and/or chemotherapy
- Currently receiving or have within the past months received topical steroid treatment in the abdominal skin area or systemic steroid (tablet/injection) treatment.
- Are pregnant or breastfeeding
- Have dermatological problems in the abdominal area (assessed by investigator)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Coloplast A/Slead
Study Sites (1)
Coloplast A/S
Humlebæk, 3050, Denmark
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Lene Feldskov
Head of preclinical department
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2017
First Posted
September 20, 2017
Study Start
September 11, 2017
Primary Completion
December 21, 2017
Study Completion
December 21, 2017
Last Updated
February 1, 2018
Record last verified: 2018-01