Evaluation of the Performance of an Adhesive Strip

Not Applicable

Completed

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

• Registration Number: NCT03419013
• Lead Sponsor: Coloplast A/S

Brief Summary

This study investigated the performance of a new adhesive strip when impacted by output

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-01
• Study Start: 2018-01-10
• Study First Submitted: 2018-01-15
• Primary Completion: 2018-01-22
• Study Completion: 2018-01-22
• Study First Submitted QC: 2018-01-31
• Last Update Submitted: 2018-01-31
• Study First Posted: 2018-02-01
• Last Update Posted: 2018-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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 test product (assessed by investigator)

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 investigator)
5. Participating in other interventional clinical investigations or have previously participated in this investigation

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 has been developed and will be tested in this investigation

Primary Outcome Measures

Name	Time	Method
Trans epidermal water loss	24 hours	trans epidermal water loss is a measure of the skins barrier function. There is always a oss of water from the skin due to evaporation. However, when the skin barrier is damaged this evaporation increases. Thus, trans epidermal water loss can be used to assess the skins barrier function

Trial Locations

Locations (1)

Coloplast A/S; 🇩🇰 Humlebæk, Denmark