NCT03257787

Brief Summary

This study investigates the performance of a new adhesive strip when impacted by output.

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 Aug 2017

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 8, 2017

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

August 18, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 22, 2017

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2017

Completed
Last Updated

November 8, 2017

Status Verified

November 1, 2017

Enrollment Period

15 days

First QC Date

August 18, 2017

Last Update Submit

November 7, 2017

Conditions

Ileostomy - Stoma

Outcome Measures

Primary Outcomes (1)

  • Trans epidermal water loss

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

    8 hours

Study Arms (1)

Test of a new adhesive strip

EXPERIMENTAL

A new adhesive strip has been developed and 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 a 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 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 2. 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 4. Having dermatological problems in the peristomal or abdominal area (assessed by investigating scientist) 5. 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 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

August 18, 2017

First Posted

August 22, 2017

Study Start

August 8, 2017

Primary Completion

August 23, 2017

Study Completion

September 23, 2017

Last Updated

November 8, 2017

Record last verified: 2017-11

Locations

DK(1)