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An Exploratory Study Investigating Human Skin Reaction to Output

NCT02351791 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2023-10-02

Study results available
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Summary

The primary purpose of the study is to investigate the impact that feces mixtures have on the peristomal skin when using a standard adhesive.

Conditions

  • Ileostomy

Interventions

OTHER

Patch 1

Patch 1:standard adhesive with own feces in sleeve

OTHER

Patch 2

Patch 2:standard adhesive with own feces mixture in sleeve

OTHER

Patch 3

Patch 3: standard adhesive with simulated feces in sleeve

OTHER

Patch 4

Patch 4:standard adhesive with simulated feces mixture in sleeve

OTHER

Patch 5

Patch 5:standard adhesive with buffer in sleeve

OTHER

Patch 6

Patch 6:standard adhesive with buffer mixture in sleeve

Sponsors & Collaborators

  • Coloplast A/S

    lead INDUSTRY

Principal Investigators

  • Lene F Nielsen, PhD · Coloplast A/S

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • Denmark

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02351791 on ClinicalTrials.gov