Evaluation of the Effect of Output on New Adhesives
A Pilot Evaluation of Newly Developed Adhesives and How They Are Impacted by Output
1 other identifier
interventional
6
1 country
1
Brief Summary
The study investigates the impanct real output has on the adhesion of a new adhesive
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 Jul 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
July 19, 2017
CompletedFirst Submitted
Initial submission to the registry
August 18, 2017
CompletedFirst Posted
Study publicly available on registry
August 22, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 13, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 13, 2017
CompletedNovember 8, 2017
November 1, 2017
2 months
August 18, 2017
November 7, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Trans epidermal water loss
The trans epidermal water loss is measured on the peristomal skin using a probe. Thrans epidermal water loss is a measure for the skins barrier function. There is always a loss of water from the skin du to natural evaporation. However, when the skin barrier is damaged more water can evaporate. Trans epridermal water loss is used to assess the damage to the skin.
8 hours
Study Arms (1)
Test of three new adhesive strips
EXPERIMENTALThe subjects test three new adhesive strips * adhesive strip A * adhesive strip B * adhesive strip C
Interventions
Strip consisting of a newly developed adhesive
Strip consisting of a newly developed adhesive
Strip consisting of a newly developed adhesive
Eligibility Criteria
You may qualify if:
- Have given written informed consent
- Be at least 18 years of age and have full legal capacity
- Have had a stoma for more than one year
- Have intact skin on the area used in the evalua-tion
- Has a stoma with a diameter up to (≤) 35 mm
- Have a peristomal area accessible for application of adhesive strips (assessed by investigating scientist)
You may not qualify if:
- Currently receiving or have within the past 2 month received radio- and/or chemotherapy
- 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 peristo-mal- or abdominal area (assessed by investigating scientist)
- Actively participating in other interventional clinical investigations or have previously participated in this investigation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Coloplast A/Slead
Study Sites (1)
Coloplast A/S
Humlebæk, 3050, Denmark
Study Officials
- PRINCIPAL INVESTIGATOR
Lene F Nielsen
Head of preclinical department
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
August 18, 2017
First Posted
August 22, 2017
Study Start
July 19, 2017
Primary Completion
September 13, 2017
Study Completion
September 13, 2017
Last Updated
November 8, 2017
Record last verified: 2017-11