Evaluation of the Influence of Output on Skin Covered by... | NCT03000881

Studies
Evaluation of the Influence of Output on Skin Covered by Adhesives

NCT03000881

Sponsor

Coloplast A/S

Status

Completed

Last Update Posted

May 31, 2017Actual

Enrollment

15Actual

Phase

Not Applicable

Conditions

Ileostomy - Stoma

Interventions

standard adhesive
New adhesive strip

Countries

Denmark

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

May 2017

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

Dec 2016Actual

Primary Completion Date

Apr 4, 2017Actual

Completion Date

Apr 4, 2017Actual

First Submitted Date

Dec 20, 2016

First Submission Date that Met QC Criteria

Dec 20, 2016

First Posted Date

Dec 22, 2016Estimated

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

May 29, 2017

Last Update Posted Date

May 31, 2017Actual

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

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cohort 6	Experimental	This is a sub-study testing the effect of real output applied under two adhesive strips after 8 hours.	Other: standard adhesive Other: New adhesive strip

Interventions

Name	Type	Description	Arm Group Labels	Other Names
standard adhesive	Other	This is a standard adhesive (hydrocolloid)	Cohort 6

Measure	Description	Time Frame
Trans Epidermal Water Loss		8 hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Have given written informed consent
Be at least 18 years of age and have full legal capacity
Have had an ileostomy for more than one year
Have intact skin on the area used in the evaluation
Has an ileostomy with a diameter up to 35 mm
Have a peristomal area accessible for application of adhesive strips

Exclusion Criteria:

Currently receiving or have within the past 2 month received radio- and/or chemotherapy
Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
Are pregnant or breastfeeding
Having dermatological problems in the peristomal- or abdominal area (assessed by investigating scientist)
Participating in other interventional clinical investigations or have previously participated in this evaluation -

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lene F Nielsen, M. Sc	Head of preclinical department	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Coloplast A/S		Humlebæk		3050	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided