Evaluation of the Influence of Output on Skin Wearing a New Adhesive

Not Applicable

Completed

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

• Registration Number: NCT03200431
• Lead Sponsor: Coloplast A/S

Brief Summary

The purpose is to investigate the impact real output has on the peristomal skin covered by a newly developed adhesive.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-26
• Study First Submitted: 2017-06-26
• Study First Submitted QC: 2017-06-26
• Study First Posted: 2017-06-27
• Primary Completion: 2017-12-11
• Study Completion: 2017-12-11
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-31
• Last Update Posted: 2018-02-01

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 evalua-tion
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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Test of a new adhesive strip	New adhesive strip	This is a sub-study testing the effect of real output applied under two adhesive strips on the skin after 24 hours. The adhesive strip is not yet part of a marketed ostomy device.

Primary Outcome Measures

Name	Time	Method
Trans epidermal water loss	24 hours	The trans epidermal water loss is measured on the peristomal skin using a probe. The Tran epidermal water loss is a measure for the skins barrier function. There is always a loss of water from the skin due to natural evaporation. However, when the skin barrier is damaged the evaporation of water increases leading to a higher trans epidermal water loss. Thus, trans epidermal water loss is used to assess the damage to the skin.

Trial Locations

Locations (1)

Coloplast A/S; 🇩🇰 Humlebæk, Denmark