Assessment of a Skin Barrier

Hollister

Status: Terminated

Conditions: Ileostomy

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02042677

5566-O

Details and patient eligibility

About

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

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.