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NCT02610907 Clinical Trial

A Pilot Evaluation of Adhesives and How They Are Impacted by Out-put

Ileostomy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02610907
Other study ID # CP265_01
Secondary ID
Status Completed
Phase N/A
First received November 16, 2015
Last updated January 19, 2016
Start date November 2015
Est. completion date January 2016

Study information
Verified date January 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 (subjects own) and simulated output have on the adhesion of adhesives.

Recruitment information / eligibility
Status Completed
Enrollment 4
Est. completion date January 2016
Est. primary completion date January 2016
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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Other:
• Buffer
The sleeve contains phosphate buffered saline buffer
• Own output
The sleeve contains the subject own ileal effluent
• simulated output
The sleeve contains simulated output

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 Remaining adhesive area of adhesive The remaining adherent area of the adhesive is assessed by subtracting the area of output and swelling from the total adhesive area. 30 hours No
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