Evaluation of the Influence of Output on a Newly Develop Adhesive

Not Applicable

Completed

• Conditions: Ileostomy - Stoma
• Interventions: Other: Standard adhesive strip; Other: New adhesive strip

• Registration Number: NCT02886403
• Lead Sponsor: Coloplast A/S

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2016-08
• Study First Submitted: 2016-08-29
• Study First Submitted QC: 2016-08-31
• Last Update Submitted: 2016-08-31
• Study First Posted: 2016-09-01
• Last Update Posted: 2016-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort 02	Standard adhesive strip	This is a sub-study testing how the adhesion of two adhesives is influenced by exposure to real output. There are two visits: The first visit: Two adhesive strips (standard adhesive strip) are applied to the peristomal skin and one of these strips is exposed to real output (contained in a sleeve) and the other strip is not. The second visit: Two adhesive strips (new adhesive strip) are applied to the peristomal skin and one of these strips is exposed to real output (contained in a sleeve) and the other strip is not.
Cohort 02	New adhesive strip	This is a sub-study testing how the adhesion of two adhesives is influenced by exposure to real output. There are two visits: The first visit: Two adhesive strips (standard adhesive strip) are applied to the peristomal skin and one of these strips is exposed to real output (contained in a sleeve) and the other strip is not. The second visit: Two adhesive strips (new adhesive strip) are applied to the peristomal skin and one of these strips is exposed to real output (contained in a sleeve) and the other strip is not.

Primary Outcome Measures

Name	Time	Method
Peel force used to removed the adhesive from the skin	12 hours

Trial Locations

Locations (1)

Coloplast A/S; 🇩🇰 Humlebaek, Denmark