Evaluation of the Influence of New Adhesives of Output on... | NCT03044262

Studies
Evaluation of the Influence of New Adhesives of Output on Skin

NCT03044262

Sponsor

Coloplast A/S

Status

Completed

Last Update Posted

May 31, 2017Actual

Enrollment

15Actual

Phase

Not Applicable

Conditions

Stoma Ileostomy

Interventions

Standard adhesive strip
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

Jan 9, 2017Actual

Primary Completion Date

Apr 25, 2017Actual

Completion Date

Apr 25, 2017Actual

First Submitted Date

Jan 31, 2017

First Submission Date that Met QC Criteria

Feb 2, 2017

First Posted Date

Feb 6, 2017Estimated

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 7	Experimental	This is a sub-study testing the effect of real output applied under two adhesive strips (standard adhesive strip and new adhesive strip) on the skin after 8 hours.	Other: Standard adhesive strip Other: New adhesive strip

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Standard adhesive strip	Other	This is a standard adhesive strip (hydrocolloid) that is part of an ostomy device	Cohort 7

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Trans epidermal water loss	The condition of the skin (trans epidemeral water loss) is measured after removing the adhesive.	8 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

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 patches/adhesive strips (assessed by investigating scientist)

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

Name	Affiliation	Role
Lene Feldskov, M. Sci	R&D scientist	Principal Investigator

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