Assessment of a Skin Barrier

User Assessment of a One-Piece Skin Barrier

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02042677

Enrollment

Registered

2014-01-23

Start date

2014-01-31

Completion date

2014-09-30

Last updated

2015-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ileostomy

Keywords

ileostomy, 1-piece, assessment, Nova, NovaLife, Dansac

Brief summary

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

Detailed description

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
barrier adhesion	10 days	Questionnaire will be provided to subject to assess barrier adhesion.
barrier tack	10 days	Questionnaire will be provided to subject to assess barrier tack.
comfort	10 days	Questionnaire will be provided to subject to assess comfort.
leakage	10 days	Questionnaire will be provided to subject to assess leakage.
ease of barrier removal	10 days	Questionnaire will be provided to subject to assess ease of barrier removal.

Countries

United Kingdom

Outcome results