NCT02886403

Brief Summary

The study investigates the impact real output has on the adhesion of adhesives.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 1, 2016

Completed
Last Updated

September 1, 2016

Status Verified

August 1, 2016

Enrollment Period

Same day

First QC Date

August 29, 2016

Last Update Submit

August 31, 2016

Conditions

Ileostomy - Stoma

Outcome Measures

Primary Outcomes (1)

  • Peel force used to removed the adhesive from the skin

    12 hours

Study Arms (1)

Cohort 02

EXPERIMENTAL

This is a sub-study testing how the adhesion of two adhesives is influenced by exposure to real output. There are two visits: The first visit: Two adhesive strips (standard adhesive strip) are applied to the peristomal skin and one of these strips is exposed to real output (contained in a sleeve) and the other strip is not. The second visit: Two adhesive strips (new adhesive strip) are applied to the peristomal skin and one of these strips is exposed to real output (contained in a sleeve) and the other strip is not.

Other: Standard adhesive stripOther: New adhesive strip

Interventions

Standard adhesive stripOTHER

A standard adhesive strip (hydrocolloid)

Cohort 02
New adhesive stripOTHER

A newly developed adhesive strip

Cohort 02

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Coloplast A/S

Humlebæk, 3050, Denmark

Location

Study Officials

  • Lene F Nielsen, MSc

    R&D scientist

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2016

First Posted

September 1, 2016

Study Start

November 1, 2015

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

September 1, 2016

Record last verified: 2016-08

Locations

DK(1)