A Pilot Evaluation of Adhesives and How They Are Impacted by Output (Round 1b)

N/ACompletedNCT02626260

Coloplast A/S4 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Ileostomy

Interventions

adhesive stripOTHER

Adhesive strip with a standard adhesive base

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Coloplast A/S

Humlebæk, Denmark

Outcomes

Primary Outcomes

Remaining adhesive area of adhesive

The remaining adherent area of the adhesive is assessed by subtracting the area of output and swelling from the total adhesive area

Time frame: 30 hours

Data from ClinicalTrials.gov

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