Evaluation of the Influence of Output on Skin Covered by Adhesives

Not Applicable

Completed

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

• Registration Number: NCT03000881
• Lead Sponsor: Coloplast A/S

Brief Summary

The study investigates the impact real output has on peristomal skin covered by two different adhesives

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2016-12-20
• Study First Submitted QC: 2016-12-20
• Study First Posted: 2016-12-22
• Primary Completion: 2017-04-04
• Study Completion: 2017-04-04
• 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

• Have given written informed consent
• Be at least 18 years of age and have full legal capacity
• Have had an ileostomy for more than one year
• Have intact skin on the area used in the evaluation
• Has an ileostomy with a diameter up to 35 mm
• Have a peristomal area accessible for application of adhesive strips

Exclusion Criteria

• Currently receiving or have within the past 2 month received radio- and/or chemotherapy
• Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
• Are pregnant or breastfeeding
• Having dermatological problems in the peristomal- or abdominal area (assessed by investigating scientist)
• 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 6	New adhesive strip	This is a sub-study testing the effect of real output applied under two adhesive strips after 8 hours.
Cohort 6	standard adhesive	This is a sub-study testing the effect of real output applied under two adhesive strips after 8 hours.

Primary Outcome Measures

Name	Time	Method
Trans Epidermal Water Loss	8 hours

Trial Locations

Locations (1)

Coloplast A/S; 🇩🇰 Humlebaek, Denmark