Assessment of a Skin Barrier | NCT02042677

Studies
Assessment of a Skin Barrier

NCT02042677

Sponsor

Hollister Incorporated

Status

Terminated

Last Update Posted

Sep 24, 2015Estimated

Enrollment

18Actual

Phase

Not provided

Conditions

Ileostomy

Interventions

Not provided

Countries

United Kingdom

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

Sep 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Slow recruitment of participants

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Sep 2014Actual

Completion Date

Sep 2014Actual

First Submitted Date

Jan 14, 2014

First Submission Date that Met QC Criteria

Jan 22, 2014

First Posted Date

Jan 23, 2014Estimated

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

Sep 22, 2015

Last Update Posted Date

Sep 24, 2015Estimated

Name	Class
St George's Healthcare NHS Trust	OTHER
London North West Healthcare NHS Trust	OTHER

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

This evaluation is being conducted to determine user perception of a new flat one-piece skin barrier compared to their normal barrier.

Detailed Description

Design:

This is a multi-site, unblinded, historically controlled assessment of a one-piece flat skin barrier. Study barriers are CE-marked. Approximately 30 subjects are enrolled in the UK.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

18Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

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

Current users of either Dansac flat Nova or NovaLife skin barriers with drainable pouches who have an ileostomy.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Heather Dennis	St. George's Hospital	Principal Investigator
Sarah Varma, Stoma Nurse	St. Mark's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St. Mark's Hospital		Harrow		HA1 3UJ	United Kingdom
St. George's Hospital