Evaluation of the Effect of Output on Newly Developed Adhesives

Coloplast

Status: Completed

Conditions: Ileostomy - Stoma

Treatments: Other: P-16; Other: Standard hydrocolloid adhesive; Other: P-15; Other: P-4

Study type: Interventional

Funder types: Industry

Identifiers

NCT03200418

CP265_10_11

Details and patient eligibility

About

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

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 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 (tab-let/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 new adhesives

Experimental group

Description:

On the peristomal area four different patches are applied to the skin. There is a bag welded on each patch. The bag contains real output. The difference between the four patches is that they consist of different adhesives. One patch is made of a standard hydrocolloid adhesive The primary endpoint is maesured after 8 hours and 24 hours And the three other patches consist of the newly developed adhesives. P-4 P-15 P-16

Treatment:

Other: P-15

Other: P-16

Other: Standard hydrocolloid adhesive

Other: P-4