NCT02886442

Brief Summary

This study investigates the impact of real output on the adhesion of two adhesives.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2016

Shorter than P25 for not_applicable

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

August 1, 2016

Completed
28 days 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
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

October 13, 2016

Status Verified

August 1, 2016

Enrollment Period

1 month

First QC Date

August 29, 2016

Last Update Submit

October 12, 2016

Conditions

Ileostomy-stoma

Outcome Measures

Primary Outcomes (1)

  • Peel force

    The peel force was measured when the adhesive was removed

    12 hours

Study Arms (1)

Cohort 3

EXPERIMENTAL

This is a sub-study testing how the adhesion of two adhesives is influenced by exposure to real output. There are two kinds of visits: Visit 1: Two adhesive strips (standard adhesive strip) are applied on the peristomal skin; one strip is exposed to real output (contained in a sleeve) and the other strip is not. Visit 2: Two adhesive strips (new adhesive strip) are applied on the peristomal skin; one strip is exposed to real output (contained in a sleeve) and the other strip is not. Visit 2:

Other: Standard adhesive stripOther: New adhesive strip

Interventions

Standard adhesive stripOTHER

This is a standard adhesive strip (hydrocolloid)

Cohort 3
New adhesive stripOTHER

This is a newly developed adhesive strip

Cohort 3

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

    Senior 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

August 1, 2016

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

October 13, 2016

Record last verified: 2016-08

Locations

DK(1)