Evaluation of the Influence of New Adhesives of Output on Skin

Not Applicable

Completed

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

• Registration Number: NCT03044262
• 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 Start: 2017-01-09
• Study First Submitted: 2017-01-31
• Study First Submitted QC: 2017-02-02
• Study First Posted: 2017-02-06
• Primary Completion: 2017-04-25
• Study Completion: 2017-04-25
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-29
• Last Update Posted: 2017-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 7	New adhesive strip	This is a sub-study testing the effect of real output applied under two adhesive strips (standard adhesive strip and new adhesive strip) on the skin after 8 hours.
Cohort 7	Standard adhesive strip	This is a sub-study testing the effect of real output applied under two adhesive strips (standard adhesive strip and new adhesive strip) on the skin after 8 hours.

Primary Outcome Measures

Name	Time	Method
Trans epidermal water loss	8 hours	The condition of the skin (trans epidemeral water loss) is measured after removing the adhesive.

Trial Locations

Locations (1)

Coloplast A/S; 🇩🇰 Humlebaek, Denmark