Assessment of a Skin Barrier

Ileostomy Clinical Trial

Official title:

User Assessment of a One-Piece Skin Barrier

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02042677
• Other study ID #: 5566-O
• 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

• Ileostomy

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