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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02042677
Other study ID # 5566-O
Secondary ID
Status Terminated
Phase N/A
First received January 14, 2014
Last updated September 22, 2015
Start date January 2014
Est. completion date September 2014

Study information

Verified date September 2015
Source Hollister Incorporated
Contact n/a
Is FDA regulated No
Health authority United Kingdom: National Health Service
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United Kingdom St. Mark's Hospital Harrow
United Kingdom St. George's Hospital London

Sponsors (3)

Lead Sponsor Collaborator
Hollister Incorporated London North West Healthcare NHS Trust, St George's Healthcare NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

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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