Evaluation of the Influence of Output on a Newly Develop Adhesive

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Coloplast

Status

Completed

Conditions

Ileostomy - Stoma

Treatments

Other: Standard adhesive strip
Other: New adhesive strip

Study type

Interventional

Funder types

Industry

Identifiers

NCT02886403
CP265_02

Details and patient eligibility

About

The study investigates the impact real output has on the adhesion of 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 an ileostomy for more than one year
  • Have intact skin on the area used in the evaluation
  • Has an ileostomy 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 peristomal- or abdominal area (assessed by investigating scientist)
  • 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)

5 participants in 1 patient group

Cohort 02
Experimental group
Description:
This is a sub-study testing how the adhesion of two adhesives is influenced by exposure to real output. There are two visits: The first visit: Two adhesive strips (standard adhesive strip) are applied to the peristomal skin and one of these strips is exposed to real output (contained in a sleeve) and the other strip is not. The second visit: Two adhesive strips (new adhesive strip) are applied to the peristomal skin and one of these strips is exposed to real output (contained in a sleeve) and the other strip is not.
Treatment:
Other: New adhesive strip
Other: Standard adhesive strip

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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