A Pilot Evaluation of Adhesives and How They Are Impacted by Out-put

Not Applicable

Completed

• Conditions: Ileostomy
• Interventions: Other: Buffer; Other: Own output; Other: simulated output

• Registration Number: NCT02610907
• Lead Sponsor: Coloplast A/S

Brief Summary

The study investigates the impact real output (subjects own) and simulated output have on the adhesion of adhesives.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-16
• Study First Submitted QC: 2015-11-19
• Study First Posted: 2015-11-20
• 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: 4

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 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. Participating in other interventional clinical investigations or have previously participated in this evaluation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort 01a	Buffer	This is a sub-study testing three patches consisting of an adhesive patch and a sleeve. The sleeve can contain one of three solutions: Buffer Own output Simulated output (digestive enzymes) All subjects will test the three solutions at the same time, hence the three patches with different solutions will be placed on the peristomal skin simultanously.
Cohort 01a	Own output	This is a sub-study testing three patches consisting of an adhesive patch and a sleeve. The sleeve can contain one of three solutions: Buffer Own output Simulated output (digestive enzymes) All subjects will test the three solutions at the same time, hence the three patches with different solutions will be placed on the peristomal skin simultanously.
Cohort 01a	simulated output	This is a sub-study testing three patches consisting of an adhesive patch and a sleeve. The sleeve can contain one of three solutions: Buffer Own output Simulated output (digestive enzymes) All subjects will test the three solutions at the same time, hence the three patches with different solutions will be placed on the peristomal skin simultanously.

Primary Outcome Measures

Name	Time	Method
Remaining adhesive area of adhesive	30 hours	The remaining adherent area of the adhesive is assessed by subtracting the area of output and swelling from the total adhesive area.

Trial Locations

Locations (1)

Coloplast A/S; 🇩🇰 Humlebaek, Denmark