The objective of this study is to determine user perception of the 2-piece flat skin barrier compared to the current Dansac flat 2-piece barrier, specifically as it relates to barrier adhesion, barrier tack, comfort, leakage, and ease of barrier…
ID
Source
Brief title
Condition
- Gastrointestinal motility and defaecation conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The data will be compiled and reported descriptively. Analysis of the
demographic profile and case report forms will be descriptive, with questions
reported in tabular format. As this is not a comparative or statistically
powered study, no hypothesis tests will be conducted.
Secondary outcome
NA
Background summary
It is desirable to develop the next generation 2-piece flat skin barrier. The
Dansac NovaLife Flat skin barriers in this study are made with a new barrier
material called GX+. This material is designed to have increased resistance to
erosion to improve wear time for those individuals whose wear time is limited
by erosion. The new anges will build on the most successful features from the
current Nova Flat product ranges.
Study objective
The objective of this study is to determine user perception of the 2-piece flat
skin barrier compared to the current Dansac flat 2-piece barrier, specifically
as it relates to barrier adhesion, barrier tack, comfort, leakage, and ease of
barrier removal.
Study design
This is a multi-site, unblinded, historically controlled assessment of the new
Dansac NovaLife 2 flat 2-piece skin barrier. Study barriers are CE-marked.
Subjects are current users of either Dansac flat Nova or NovaLife skin barriers
with drainable pouches who have an ileostomy or colostomy. Approximately 30
subjects are enrolled. Subjects are recruited from sites in EU countries. Each
subject will be provided 1 box of
5 skin barriers and 1 box of 10 drainable pouches (additional pouches will be
provided as needed). Subjects wear the study skin barriers according to their
normal habit for 5 consecutive wears. Subjects record wear time and their
assessment of relevant characteristics for each skin barrier. In addition, they
provide an assessment in comparison to the barrier they normally use
(historical control). The study is comprised of 2 visits, an enrollment visit
and a completion visit. A phone call is scheduled between the two subject
visits. Individual participation is for approximately 10 days based on an
average of 2 days wear for each skin barrier (length of study participation may
vary depending on typical individual wear time). The Ostomy Comprehensive
Health and Life Assessment_ABBR, will be completed at Visit 1.
Intervention
Use of The DansacNovaLife Flat skin barriers GX+.
Study burden and risks
This study is considered of minimal risk in that the anticipated risks of harm
are no greater, considering the probability and magnitude, than those
ordinarily encountered in the daily routine of the subjects. Subject will not
have any benefit from the study.
2000 Hollister Drive
Libertyville, Illinois 60048
US
2000 Hollister Drive
Libertyville, Illinois 60048
US
Listed location countries
Age
Inclusion criteria
- is at least 18 years of age.
- has an ileostomy or colostomy
- is at least six weeks postoperative.
- lives and cares for their stoma independently in the community.
- currently uses a Dansac Nova or NovaLife 2-piece flat barrier
- currently uses a drainable pouch.
- is able to wear a 2-piece flat cut-to-fit 55 mm flange.
- 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.
Exclusion criteria
- has a fistula on or near the stoma.
- has been involved in a study involving stoma care within the last 30 days.
- is pregnant or lactating.
- is undergoing chemotherapy, radiation or steroid therapy.
- has an existing medical condition that would compromise their participation in the study.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL47398.056.14 |