NCT03044262CompletedNot Applicable
Evaluation of the Influence of Output on Skin Covered by Newly Developed Adhesives
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Coloplast A/S
- Enrollment
- 15
- Locations
- 2
- Primary Endpoint
- Trans epidermal water loss
Study Overview
Brief Summary
The study investigates the impact real output has on peristomal skin covered by a newly developed adhesive and a standard adhesive
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Have given written informed consent
- •Be at least 18 years of age and have full legal capacity
- •Have had an ileostomy for more than one year
- •Have intact skin on the area used in the evaluation
- •Has an ileostomy with a diameter up to (≤) 35 mm
- •Have a peristomal area accessible for application of patches/adhesive strips (assessed by investigating scientist)
Exclusion Criteria
- •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 peristomal- or abdominal area (assessed by investigating scientist)
- •Participating in other interventional clinical investigations or have previously participated in this evaluation
Outcomes
Primary Outcomes
Trans epidermal water loss
Time Frame: 8 hours
The condition of the skin (trans epidemeral water loss) is measured after removing the adhesive.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
Loading locations...
Similar Trials
Completed
Not Applicable
Evaluation of the Influence of Output on Skin Covered by Newly Developed AdhesivesIleostomy - StomaNCT02886455Coloplast A/S4
Completed
Not Applicable
Evaluation of the Effect of Output on Skin Covered by a New AdhesiveIleostomy - StomaNCT03044288Coloplast A/S6
Completed
Not Applicable
Evaluation of the Influence of Output on Skin Wearing a New AdhesiveIleostomy - StomaNCT03200431Coloplast A/S6
Completed
Not Applicable
The Influence of Output on Skin Covered by Adhesive With TopfilmIleostomy - StomaNCT03044275Coloplast A/S15
Completed
Not Applicable
Evaluation of the Influence of Output on Skin Covered by Adhesives (Round 5)Ileostomy - StomaNCT02992444Coloplast A/S5