The Influence of Output on Skin Covered by Adhesive With Topfilm
Not Applicable
Completed
- Conditions
- Ileostomy - Stoma
- Registration Number
- NCT03044275
- Lead Sponsor
- Coloplast A/S
- Brief Summary
The study investigates the impact real output has on peristomal skin covered by a newly developed adhesive with topfilm and a standard adhesive with a topfilm.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
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 -
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Trans epidermal water loss 6 hours the condition of the skin (trans epidermal water loss) is measured after removing the adhesive from the skin
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular interactions between Topfilm adhesives and peristomal skin proteins influence ileostomy output tolerance?
How does the new adhesive strip with Topfilm compare to standard adhesives in preventing peristomal skin excoriation in ileostomy patients?
Which biomarkers correlate with peristomal skin barrier function improvement using Topfilm adhesives in ileostomy management?
What adverse events are associated with Topfilm adhesive strips in ileostomy patients, and how are they managed clinically?
Are there alternative adhesive formulations or competitor products that demonstrate superior peristomal skin protection in ileostomy management?
Trial Locations
- Locations (1)
Coloplast A/S
🇩🇰Humlebaek, Denmark
Coloplast A/S🇩🇰Humlebaek, Denmark