NCT03044288

Brief Summary

The study investigates the impact real output has on peristomal skin covered by a newly developed adhesive and a standard 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 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

January 23, 2017

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 31, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 7, 2017

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 9, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 9, 2017

Completed
Last Updated

May 31, 2017

Status Verified

May 1, 2017

Enrollment Period

17 days

First QC Date

January 31, 2017

Last Update Submit

May 29, 2017

Conditions

Ileostomy - Stoma

Outcome Measures

Primary Outcomes (1)

  • Trans epidermal water loss

    The condition of the skin is measure by trans epidermal water loss after removing the adhesive strip.

    6 hours

Study Arms (1)

Cohort 9

EXPERIMENTAL

This is a sub-study testing the effect of real output applied under two adhesive strips on the skin. Standard adhesive strip and a strip with a newly developed adhesive (new adhesive strip)

Other: New adhesive stripOther: Standard adhesive strip

Interventions

New adhesive stripOTHER

This is a strip made of a newly developed adhesive. This adhesive might in the future be part of an ostomy product.

Cohort 9
Standard adhesive stripOTHER

this is a standard adhesive strip (hydrocolloid). This adhesive is currently used in marketed ostomy devices.

Cohort 9

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, M. Sci

    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

January 31, 2017

First Posted

February 7, 2017

Study Start

January 23, 2017

Primary Completion

February 9, 2017

Study Completion

February 9, 2017

Last Updated

May 31, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)