Evaluation of the Performance of a New Adhesive Strip

Coloplast

Status: Completed

Conditions: Ileostomy - Stoma

Treatments: Other: new adhesive strip

Study type: Interventional

Funder types: Industry

Identifiers

NCT03257787

CP265_15

Details and patient eligibility

About

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

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Test of a new adhesive strip

Experimental group

Description:

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

Treatment:

Other: new adhesive strip