Investigating the Performance of a New Adhesive Strip

Not Applicable

Completed

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

• Registration Number: NCT03423134
• Lead Sponsor: Coloplast A/S

Brief Summary

This study investigates the performance of a new adhesive

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-25
• Study First Submitted: 2018-01-31
• Study First Submitted QC: 2018-01-31
• Study First Posted: 2018-02-06
• Primary Completion: 2018-02-20
• Study Completion: 2018-02-20
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-31
• Last Update Posted: 2019-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

1. Have given written informed consent
2. Be at least 18 years of age and have full legal capacity
3. Have had a stoma for more than one year
4. Have intact skin on the area used in the evaluation
5. Has a stoma 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. Actively participating in other interventional clinical investigations or have previously participated in this investigation.

5.1. Exception: Participation in other Coloplast in-house clinical investigations are accepted under the circumstances of otherwise complying with the Inclusion and exclusion criteria of this protocol (CP265)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Test of new adhesive strip	New adhesive strip	A new adhesive strip will be tested in this investigation

Primary Outcome Measures

Name	Time	Method
trans epidermal water loss	24 hours	The trans epidermal water loss is a measure for the skins barrier function. There is always a loss of water from the skin due to evaporation. When the skin barrier is damaged the evaporation of water increases. Thus, trans epidermal water loss can be used to assess skin damage

Trial Locations

Locations (1)

Coloplast A/S; 🇩🇰 Humlebæk, Denmark