NCT03423134

Brief Summary

This study investigates the performance of a new adhesive

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

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

January 25, 2018

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 31, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 6, 2018

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2018

Completed
Last Updated

February 1, 2019

Status Verified

January 1, 2019

Enrollment Period

26 days

First QC Date

January 31, 2018

Last Update Submit

January 31, 2019

Conditions

Ileostomy - Stoma

Outcome Measures

Primary Outcomes (1)

  • trans epidermal water loss

    The trans epidermal water loss is a measure for the skins barrier function. There is always a loss of water from the skin due to evaporation. When the skin barrier is damaged the evaporation of water increases. Thus, trans epidermal water loss can be used to assess skin damage

    24 hours

Study Arms (1)

Test of new adhesive strip

EXPERIMENTAL

A new adhesive strip will be tested in this investigation

Other: New adhesive strip

Interventions

New adhesive stripOTHER

This is a strip made of a newly developed adhesive

Test of new adhesive strip

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 a stoma for more than one year
  • Have intact skin on the area used in the evaluation
  • Has a stoma 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)
  • Actively participating in other interventional clinical investigations or have previously participated in this investigation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Coloplast A/S

Humlebæk, 3050, Denmark

Location

Study Officials

  • Lene F Nielsen

    Head of the pre-clinical 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

January 31, 2018

First Posted

February 6, 2018

Study Start

January 25, 2018

Primary Completion

February 20, 2018

Study Completion

February 20, 2018

Last Updated

February 1, 2019

Record last verified: 2019-01

Locations

DK(1)