Evaluation of the Influence of Output on Skin Covered by Adhesives (Round 5)

Coloplast

Status: Completed

Conditions: Ileostomy - Stoma

Treatments: Other: Standard adhesive strip; Other: Experimental adhesive strip

Study type: Interventional

Funder types: Industry

Identifiers

NCT02992444

CP265_05

Details and patient eligibility

About

This study investigates the impact real output has on peristomal skin covered by an adhesive

Enrollment: 5 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 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

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

Cohort 5

Experimental group

Description:

This is a sub-study testing the effect of real output applied under two adhesive strips on the skin after 8 hours. There is one visit: Two adhesive strips (standard adhesive strip and Experimental adhesive strip)are applied on the peristomal skin and allowed to sit for 8hours before being removed.

Treatment:

Other: Experimental adhesive strip

Other: Standard adhesive strip