NCT03000881

Brief Summary

The study investigates the impact real output has on peristomal skin covered by two different adhesives

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 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

December 1, 2016

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

December 20, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 22, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2017

Completed
Last Updated

May 31, 2017

Status Verified

May 1, 2017

Enrollment Period

4 months

First QC Date

December 20, 2016

Last Update Submit

May 29, 2017

Conditions

Ileostomy - Stoma

Outcome Measures

Primary Outcomes (1)

  • Trans Epidermal Water Loss

    8 hours

Study Arms (1)

Cohort 6

EXPERIMENTAL

This is a sub-study testing the effect of real output applied under two adhesive strips after 8 hours.

Other: standard adhesiveOther: New adhesive strip

Interventions

standard adhesiveOTHER

This is a standard adhesive (hydrocolloid)

Cohort 6
New adhesive stripOTHER

This is a newly developed adhesive strip

Cohort 6

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 adhesive strips

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, M. Sc

    Head of preclinical department

    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

December 20, 2016

First Posted

December 22, 2016

Study Start

December 1, 2016

Primary Completion

April 4, 2017

Study Completion

April 4, 2017

Last Updated

May 31, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)