Assessment of a Skin Barrier

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-09-30

Brief Summary

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This evaluation is being conducted to determine user perception of a new flat one-piece skin barrier compared to their normal barrier.

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Detailed Description

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Design:

This is a multi-site, unblinded, historically controlled assessment of a one-piece flat skin barrier. Study barriers are CE-marked. Approximately 30 subjects are enrolled in the UK.

Conditions

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Ileostomy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. is at least 18 years of age.
2. has an ileostomy.
3. is at least six weeks postoperative.
4. lives and cares for their stoma independently in the community.
5. currently uses a Dansac Nova or NovaLife 1-piece flat skin barrier.
6. currently uses a drainable pouch.
7. is able to wear a 1-piece flat cut-to-fit 10-55 mm.
8. Has a peristomal skin irritation score of 2 or less.
9. is willing to follow the protocol as demonstrated by signing the informed consent and who in the opinion of the investigator is qualified to participate.

Exclusion Criteria

1. has a fistula on or near the stoma.
2. has been involved in a study involving stoma care with in the last 30 days.
3. is pregnant or lactating, as determined by interview only.
4. is undergoing chemotherapy, radiation or steroid therapy.
5. has an existing medical condition that would compromise their participation in the study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No