Evaluation of the Effect of Output on New Adhesives

Not Applicable

Completed

• Conditions: Ileostomy - Stoma
• Interventions: Other: Adhesive strip A; Other: Adhesive strip B; Other: Adhesive strip C

• Registration Number: NCT03257774
• Lead Sponsor: Coloplast A/S

Brief Summary

The study investigates the impanct real output has on the adhesion of a new adhesive

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-19
• Study First Submitted: 2017-08-18
• Study First Submitted QC: 2017-08-18
• Study First Posted: 2017-08-22
• Primary Completion: 2017-09-13
• Study Completion: 2017-09-13
• 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 evalua-tion
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 peristo-mal- 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 three new adhesive strips	Adhesive strip A	The subjects test three new adhesive strips * adhesive strip A * adhesive strip B * adhesive strip C
Test of three new adhesive strips	Adhesive strip C	The subjects test three new adhesive strips * adhesive strip A * adhesive strip B * adhesive strip C
Test of three new adhesive strips	Adhesive strip B	The subjects test three new adhesive strips * adhesive strip A * adhesive strip B * adhesive strip C

Primary Outcome Measures

Name	Time	Method
Trans epidermal water loss	8 hours	The trans epidermal water loss is measured on the peristomal skin using a probe. Thrans epidermal water loss is a measure for the skins barrier function. There is always a loss of water from the skin du to natural evaporation. However, when the skin barrier is damaged more water can evaporate. Trans epridermal water loss is used to assess the damage to the skin.

Trial Locations

Locations (1)

Coloplast A/S; 🇩🇰 Humlebæk, Denmark