NCT03044275

Brief Summary

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

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 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 16, 2017

Completed
15 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
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2017

Completed
Last Updated

May 31, 2017

Status Verified

May 1, 2017

Enrollment Period

4 months

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 (trans epidermal water loss) is measured after removing the adhesive from the skin

    6 hours

Study Arms (1)

Cohort 8

EXPERIMENTAL

This is a sub-study testing the effect of real output on the skin applied under two adhesive strips. New adhesive strip Standard adhesive strip

Other: New adhesive stripOther: Standard adhesive strip

Interventions

New adhesive stripOTHER

This is a newly developed adhesive strip that in the future might be part of an ostomy device

Cohort 8
Standard adhesive stripOTHER

This is a standard adhesive strip (hydrocolloid). The adhesive is a part of an ostomy device

Cohort 8

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 Feldskov, 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 16, 2017

Primary Completion

May 10, 2017

Study Completion

May 10, 2017

Last Updated

May 31, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)