Ileostomy Clinical Trial
Official title:
User Assessment of a One-Piece Skin Barrier
Verified date | September 2015 |
Source | Hollister Incorporated |
Contact | n/a |
Is FDA regulated | No |
Health authority | United Kingdom: National Health Service |
Study type | Observational |
This evaluation is being conducted to determine user perception of a new flat one-piece skin barrier compared to their normal barrier.
Status | Terminated |
Enrollment | 18 |
Est. completion date | September 2014 |
Est. primary completion date | September 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United Kingdom | St. Mark's Hospital | Harrow | |
United Kingdom | St. George's Hospital | London |
Lead Sponsor | Collaborator |
---|---|
Hollister Incorporated | London North West Healthcare NHS Trust, St George's Healthcare NHS Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | barrier adhesion | Questionnaire will be provided to subject to assess barrier adhesion. | 10 days | No |
Primary | barrier tack | Questionnaire will be provided to subject to assess barrier tack. | 10 days | No |
Primary | comfort | Questionnaire will be provided to subject to assess comfort. | 10 days | No |
Primary | leakage | Questionnaire will be provided to subject to assess leakage. | 10 days | No |
Primary | ease of barrier removal | Questionnaire will be provided to subject to assess ease of barrier removal. | 10 days | No |
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