An Exploratory Study Investigating Adhesive Reaction to Output

Summary

The objective is to investigate the impact that faecal output has on adhesives.

Conditions

• Ileostomy

Interventions

OTHER

Patch 1

Patch 1 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve of Patch 1 contains the subjects own feces. The Patch is placed over the adhesive strip to investigate the impact of output on the adhesive strip

OTHER

Patch 2

Patch 2 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve Patch 2 contains the subjects own feces and filler. The Patch is placed over the adhesive strip to investigate the impact of output on the adhesive strip

OTHER

Patch 3

Patch 3 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve of Patch 3 contains simulated output. The Patch is placed over the adhesive strip to invesitgate the impact of output on the adhesive strip

OTHER

Patch 4

Patch 4 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve of Patch 4 contains simulated output with filler. The Patch is placed over the adhesive strip to investigate the impact of output on the adhesive strip

OTHER

patch 5

Patch 5 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve of Patch 5 contains buffer. The Patch is placed over the adhesive strip to investigate the impact of output on the adhesive strip

OTHER

Patch 6

Patch 6 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve of Patch 6 contains buffer with filler. The Patch is placed over the adhesive strip to investigate the impact of output on the adhesive strip

Sponsors & Collaborators

• Coloplast A/S

  lead INDUSTRY

Principal Investigators

• Birte P Jakobsen, MD · Medical Director

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-10-31

Primary Completion

2016-01-31

Completion

2016-01-31

Countries

• Denmark

Study Locations