An Exploratory Study Investigating Adhesive Reaction to Output

Not Applicable

Completed

• Conditions: Ileostomy

• Registration Number: NCT02594085
• Lead Sponsor: Coloplast A/S

Brief Summary

The objective is to investigate the impact that faecal output has on adhesives.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-30
• Study First Submitted QC: 2015-10-30
• Study First Posted: 2015-11-01
• Status Verified: 2016-01
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Last Update Submitted: 2016-01-19
• Last Update Posted: 2016-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 3 months
4. Have intact skin on the area used in the evaluation
5. Has an ileostomy with a diameter (≤) 35mm

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 area
5. Convex user
6. Participate in other interventional clinical investigations

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Remaining adherent area of the adhesive	8 hours	The remaining adherent area of the adhesive strips is assessed by measuring the difference in total area of output and swelling.

Trial Locations

Locations (1)

Coloplast A/S; 🇩🇰 Humlebaek, Denmark