Study Stopped
Slow recruitment of participants
Assessment of a Skin Barrier
User Assessment of a One-Piece Skin Barrier
1 other identifier
observational
18
1 country
2
Brief Summary
This evaluation is being conducted to determine user perception of a new flat one-piece skin barrier compared to their normal barrier.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2014
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 14, 2014
CompletedFirst Posted
Study publicly available on registry
January 23, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedSeptember 24, 2015
September 1, 2015
8 months
January 14, 2014
September 22, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
barrier adhesion
Questionnaire will be provided to subject to assess barrier adhesion.
10 days
barrier tack
Questionnaire will be provided to subject to assess barrier tack.
10 days
comfort
Questionnaire will be provided to subject to assess comfort.
10 days
leakage
Questionnaire will be provided to subject to assess leakage.
10 days
ease of barrier removal
Questionnaire will be provided to subject to assess ease of barrier removal.
10 days
Eligibility Criteria
Current users of either Dansac flat Nova or NovaLife skin barriers with drainable pouches who have an ileostomy.
You may qualify if:
- is at least 18 years of age.
- has an ileostomy.
- is at least six weeks postoperative.
- lives and cares for their stoma independently in the community.
- currently uses a Dansac Nova or NovaLife 1-piece flat skin barrier.
- currently uses a drainable pouch.
- is able to wear a 1-piece flat cut-to-fit 10-55 mm.
- Has a peristomal skin irritation score of 2 or less.
- 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.
You may not qualify if:
- has a fistula on or near the stoma.
- has been involved in a study involving stoma care with in the last 30 days.
- is pregnant or lactating, as determined by interview only.
- is undergoing chemotherapy, radiation or steroid therapy.
- has an existing medical condition that would compromise their participation in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hollister Incorporatedlead
- St George's Healthcare NHS Trustcollaborator
- London North West Healthcare NHS Trustcollaborator
Study Sites (2)
St. Mark's Hospital
Harrow, HA1 3UJ, United Kingdom
St. George's Hospital
London, SW17 0QT, United Kingdom
Study Officials
- PRINCIPAL INVESTIGATOR
Heather Dennis
St. George's Hospital
- PRINCIPAL INVESTIGATOR
Sarah Varma, Stoma Nurse
St. Mark's Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 14, 2014
First Posted
January 23, 2014
Study Start
January 1, 2014
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
September 24, 2015
Record last verified: 2015-09