Evaluation of the Influence of Output on Skin Covered by Newly Developed Adhesives

Not Applicable

Completed

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

• Registration Number: NCT02886455
• Lead Sponsor: Coloplast A/S

Brief Summary

The study investigates the impact real output has on peristomal skin covered by a newly developed adhesive and a standard adhesive.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-29
• Study First Submitted QC: 2016-08-29
• Study Start: 2016-09
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Study First Posted: 2016-09-01
• Status Verified: 2016-10
• 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 4	Standard adhesive strip	This is a sub-study testing the effect of real output applied under two adhesive strips on the skin at two different time points (4 and 24 hours). There are two visits: Visit 1: Two adhesive strips (standard adhesive strip and new adhesive strip)contaminated with the subjects own output are applied on the peristomal skin and allowed to sit for 4 hours before being removed Visit 2: Two adhesive strips (standard adhesive strip and new adhesive strip)contaminated with the subjects own output are applied on the peristomal skin and allowed to sit for 24 hours before being removed
Cohort 4	New adhesive strip	This is a sub-study testing the effect of real output applied under two adhesive strips on the skin at two different time points (4 and 24 hours). There are two visits: Visit 1: Two adhesive strips (standard adhesive strip and new adhesive strip)contaminated with the subjects own output are applied on the peristomal skin and allowed to sit for 4 hours before being removed Visit 2: Two adhesive strips (standard adhesive strip and new adhesive strip)contaminated with the subjects own output are applied on the peristomal skin and allowed to sit for 24 hours before being removed

Primary Outcome Measures

Name	Time	Method
Trans epidermal water loss	4-24 hours	The condition of the skin (transepidermal water loss) is measured after removing the adhesive by TE

Trial Locations

Locations (1)

Coloplast A/S; 🇩🇰 Humlebaek, Denmark