A Pilot Evaluation of Adhesives and How They Are Impacted by Out-put

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Coloplast

Status

Completed

Conditions

Ileostomy

Treatments

Other: Own output
Other: simulated output
Other: Buffer

Study type

Interventional

Funder types

Industry

Identifiers

NCT02610907
CP265_01

Details and patient eligibility

About

The study investigates the impact real output (subjects own) and simulated output have on the adhesion of adhesives.

Enrollment

4 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)

4 participants in 1 patient group

Cohort 01a
Experimental group
Description:
This is a sub-study testing three patches consisting of an adhesive patch and a sleeve. The sleeve can contain one of three solutions: Buffer Own output Simulated output (digestive enzymes) All subjects will test the three solutions at the same time, hence the three patches with different solutions will be placed on the peristomal skin simultanously.
Treatment:
Other: Buffer
Other: simulated output
Other: Own output

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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