Evaluation of the Performance of a New Adhesive Strip

Not Applicable

Completed

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

• Registration Number: NCT03257787
• Lead Sponsor: Coloplast A/S

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-08
• Study First Submitted: 2017-08-18
• Study First Submitted QC: 2017-08-18
• Study First Posted: 2017-08-22
• Primary Completion: 2017-08-23
• Study Completion: 2017-09-23
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-07
• Last Update Posted: 2017-11-08

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 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	A new adhesive strip has been developed and will be tested in this investigation.

Primary Outcome Measures

Name	Time	Method
Trans epidermal water loss	8 hours	The trans epidermal water loss is a measure of the skins barrier function. There is always a loss of water from the skin due to evaporation. However, when the barrier is damaged this evaporation increases. Thus, trans epidermal water loss can be used to assess damage to the skin.

Trial Locations

Locations (1)

Coloplast A/S; 🇩🇰 Humlebæk, Denmark