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NCT02886403 Clinical Trial

Evaluation of the Influence of Output on a Newly Develop Adhesive

Ileostomy - Stoma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02886403
Other study ID # CP265_02
Secondary ID
Status Completed
Phase N/A
First received August 29, 2016
Last updated August 31, 2016
Start date November 2015
Est. completion date November 2015

Study information
Verified date August 2016
Source Coloplast A/S
Contact n/a
Is FDA regulated No
Health authority Denmark: Ethics Committee
Study type Interventional

Clinical Trial Summary

The study investigates the impact real output has on the adhesion of adhesives.

Recruitment information / eligibility
Status Completed
Enrollment 5
Est. completion date November 2015
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender Both
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 had an ileostomy for more than one year

4. Have intact skin on the area used in the evaluation

5. Has an ileostomy with a diameter up to (=) 35 mm

6. Have a peristomal area accessible for application of patches/adhesive strips (assessed by investigating scientist)

Exclusion Criteria:

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

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

3. Are pregnant or breastfeeding

4. Having dermatological problems in the peristomal- or abdominal area (assessed by investigating scientist)

5. Participating in other interventional clinical investigations or have previously participated in this evaluation

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Other:
• Standard adhesive strip
A standard adhesive strip (hydrocolloid)
• New adhesive strip
A newly developed adhesive strip

Locations
Country Name City State
Denmark Coloplast A/S Humlebaek

Sponsors (1)
Lead Sponsor Collaborator
Coloplast A/S

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Peel force used to removed the adhesive from the skin 12 hours No
See also
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Recruiting NCT03424447 - Stimulation of the Efferent Loop Before Loop Ileostomy Closure Phase 2
Completed NCT03770078 - Assessment of New Enhanced Ostomy Device in Real-life Settings in Subjects Having a Stoma N/A