colostomy ileostomy
Conditions
Interventions
Use of The DansacNovaLife Flat skin barriers GX+.
Sponsors
Dansac Limited/ Hollister Incorporated
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Netherlands
Outcome results
None listed