Assessment of the Effect of Output on New Adhesives

Coloplast

Status: Completed

Conditions: Ileostomy - Stoma

Treatments: Other: Standard hydrocolloid adhesive patch; Other: LT-21; Other: LT-2; Other: 33-20

Study type: Interventional

Funder types: Industry

Identifiers

NCT03331783

CP265_21_22

Details and patient eligibility

About

The study investigates the impact real output has on adhesion of new adhesives

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have given written informed consent
• Be at least 18 years of age and have full legal capacity
• Have had a stoma for more than one year
• Have intact skin on the area used in the evaluation
• Has a stoma with a diameter up to (≤) 35 mm
• Have a peristomal area accessible for application of patches/adhesive strips (assessed by investigating scientist)

Exclusion criteria

• Currently receiving or have within the past 2 month received radio- and/or chemotherapy
• Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
• Are pregnant or breastfeeding
• Having dermatological problems in the peri-stomal- or abdominal area (assessed by investigating scientist)
• 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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5 participants in 1 patient group

Test of new adhesive strips

Experimental group

Description:

On the peristomal skin 4 different patches are applied to the skin (Standard hydrocolloid adhesive patch; LT-2, LT21 and 33-20. There is a bag welded to each patch. Tthe bag contains real output. The difference between the four patches is that they are made of four different adhesives. The primary endpoint is measured after 8 hours and 24 hours.

Treatment:

Other: 33-20

Other: LT-2

Other: LT-21

Other: Standard hydrocolloid adhesive patch