Peristomal Skin Irritation Clinical Trial
Official title:
Peristomal Skin Irritation: A Preliminary Evaluation of the CASTLE Barrier Prototype for People With Intestinal Stomas
The purpose of this study is to provide preliminary assessment of the safety and performance of a novel barrier formulation (CASTLE) in a small population of subjects with irritated peristomal skin.
| Status | Terminated |
| Enrollment | 3 |
| Est. completion date | August 2012 |
| Est. primary completion date | February 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - at least 18 years of age - has colostomy or ileostomy - current uses two piece tape bordered barrier - has mild to moderate peristomal skin irritation - cares for their stoma independently in the community - at least 3 months post-operative - provides informed consent Exclusion Criteria: - has fistula on or near stoma - has been involved in stoma care study in the last 30 days - is pregnant or lactating (determined by interview only) - has existing medical condition that would compromise their participation or follow-up - currently uses convex ostomy products, paste and/or rings - is allergic to test barrier components - is undergoing chemo- or radiotherapy that may affect the interpretation of the results |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | York Teaching Hospital | York |
| Lead Sponsor | Collaborator |
|---|---|
| Hollister Incorporated |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Peristomal skin irritation | 30 days | Yes | |
| Secondary | Security | wear time leakage barrier erosion | 30 days | No |