Evaluation of the Ability of Newly Developed Adhesives to Absorb Moisture

Coloplast

Status: Completed

Conditions: Stoma Ileostomy

Treatments: Other: test patch

Study type: Interventional

Funder types: Industry

Identifiers

NCT03619226

CP284_1

Details and patient eligibility

About

The aim of this evaluation is to investigate the ability of newly developed adhesive patches to absorb moisture.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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 intact skin on the area used in the evaluation
4. Have an abdominal area accessible for application of test product (assessed by investigator)
5. Negative pregnancy test for fertile women
6. Signed document claiming use of safe contraceptives for fertile women

Exclusion criteria

1. Currently receiving or have within the past 2 month received radio- and/or chemo-therapy
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 investigator)
5. Participating in interventional clinical investigations or have previously participated in this evaluation. Exception: Participation in other Coloplast sponsored clinical investigations or evaluations is accepted under the circumstances that the subject has paused the activities in the investigation/evaluation and are otherwise complying with the inclusion and exclusion criteria of this (CP284) Evaluation

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 patch

Experimental group

Description:

two adhesive patches are applied to the abdominal area

Treatment:

Other: test patch