A Pilot Evaluation of Adhesives and How They Are Impacted by Output

Not Applicable

Completed

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

• Registration Number: NCT02886442
• Lead Sponsor: Coloplast A/S

Brief Summary

This study investigates the impact of real output on the adhesion of two adhesives.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-08
• Study Start: 2016-08
• Study First Submitted: 2016-08-29
• Study First Submitted QC: 2016-08-31
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Study First Posted: 2016-09-01
• Last Update Submitted: 2016-10-12
• Last Update Posted: 2016-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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 3	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 kinds of visits: Visit 1: Two adhesive strips (standard adhesive strip) are applied on the peristomal skin; one strip is exposed to real output (contained in a sleeve) and the other strip is not. Visit 2: Two adhesive strips (new adhesive strip) are applied on the peristomal skin; one strip is exposed to real output (contained in a sleeve) and the other strip is not. Visit 2:
Cohort 3	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 kinds of visits: Visit 1: Two adhesive strips (standard adhesive strip) are applied on the peristomal skin; one strip is exposed to real output (contained in a sleeve) and the other strip is not. Visit 2: Two adhesive strips (new adhesive strip) are applied on the peristomal skin; one strip is exposed to real output (contained in a sleeve) and the other strip is not. Visit 2:

Primary Outcome Measures

Name	Time	Method
Peel force	12 hours	The peel force was measured when the adhesive was removed

Trial Locations

Locations (1)

Coloplast A/S; 🇩🇰 Humlebaek, Denmark