Preliminary Evaluation of CASTLE Barrier North American P... | NCT01413672

Studies
Preliminary Evaluation of CASTLE Barrier North American Prototype

NCT01413672

Sponsor

Hollister Incorporated

Status

Completed

Last Update Posted

Dec 12, 2011Estimated

Enrollment

30Actual

Phase

Not provided

Conditions

Peristomal Skin Complication

Interventions

Use of CASTLE barrier

Countries

United States
Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2011

Primary Completion Date

Dec 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Aug 6, 2011

First Submission Date that Met QC Criteria

Aug 9, 2011

First Posted Date

Aug 10, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 9, 2011

Last Update Posted Date

Dec 12, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine if an ostomy barrier that promotes a healthy skin environment will result in reduced peristomal skin irritation.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
person with ostomy		Community dwelling subject with either colostomy or ileostomy and at least 3 months post-surgery.	Device: Use of CASTLE barrier

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Use of CASTLE barrier	Device	Test barrier to be used in place of normal barrier. Otherwise normal routine is followed	person with ostomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Peristomal skin irritation		30 days

Secondary Outcomes

Measure	Description	Time Frame
Security	wear time, lifting of barrier from skin, leakage	30 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

at least 18 years of age has colostomy or ileostomy current user of two-piece, flat, tape bordered barrier mild to moderate skin peristomal skin irritation community dwelling and cares for stoma independently at least 3 months post-operative provides informed consent

Exclusion Criteria:

presence of fistula on or near stoma prior participation in stoma care study within past 30 days pregnant or lactating (interview only) uses convex product, paste and/or rings known allergy to test barrier composition existing medical condition or therapy that might affect ability to participate or interpretation of study results

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

subjects currently known to investigators

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Richard Murahata, Ph.D.	Hollister Incorporated	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Burke Pharmaceutical Research		Hot Springs	Arkansas	71913	United States
ET Nursing Services