Assessment of a Skin Barrier

Terminated

• Conditions: Ileostomy

• Registration Number: NCT02042677
• Lead Sponsor: Hollister Incorporated

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.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-14
• Study First Submitted QC: 2014-01-22
• Study First Posted: 2014-01-23
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-22
• Last Update Posted: 2015-09-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
barrier adhesion	10 days	Questionnaire will be provided to subject to assess barrier adhesion.
leakage	10 days	Questionnaire will be provided to subject to assess leakage.
barrier tack	10 days	Questionnaire will be provided to subject to assess barrier tack.
ease of barrier removal	10 days	Questionnaire will be provided to subject to assess ease of barrier removal.
comfort	10 days	Questionnaire will be provided to subject to assess comfort.

Trial Locations

Locations (2)

St. Mark's Hospital; 🇬🇧 Harrow, United Kingdom

St. George's Hospital; 🇬🇧 London, United Kingdom