NCT03439176

Brief Summary

The adhesion of the new adhesive strips is investigated on healthy volunteers

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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 15, 2018

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

January 31, 2018

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 20, 2018

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

1 month

First QC Date

January 31, 2018

Last Update Submit

January 22, 2020

Conditions

Ileostomy - Stoma

Outcome Measures

Primary Outcomes (1)

  • Swelling of the adhesive

    Swelling of adhesive strips measured by weight (difference between the weight of the strip before and after use)

    24 hours

Study Arms (1)

Test of new adhesive strips

EXPERIMENTAL

The subjects will test adhesives strips made of 4 different adhesives: Standard adhesive 1 Standard adhesive 2 PL4 PL16-L

Other: Standard adhesive 1Other: Standard adhesive 2Other: PL4Other: PL16-L

Interventions

Standard adhesive 1OTHER

This strip contains a standard hydrocolloid adhesive found in ostomy devices

Test of new adhesive strips
Standard adhesive 2OTHER

This strip contains a standard hydrocolloid adhesive found in ostomy devices

Test of new adhesive strips
PL4OTHER

This strip contains a new adhesive

Test of new adhesive strips
PL16-LOTHER

This strip contains a new adhesive

Test of new adhesive strips

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
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 intact skin on the area used in the investigation

You may not qualify if:

  • Currently receiving or have within the past 2 months received radio- and/or chemotherapy
  • Currently receiving or have within the past months received topical steroid treatment in the abdominal skin area or systemic steroid (tablet/injection) treatment.
  • Are pregnant or breastfeeding
  • Have dermatological problems in the abdominal area (assessed by investigator)

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 20, 2018

Study Start

January 15, 2018

Primary Completion

February 15, 2018

Study Completion

June 30, 2020

Last Updated

January 27, 2020

Record last verified: 2020-01

Locations

DK(1)