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CompletedNCT03289013Updated Feb 1, 2018

Assessement of the Peal Force Needed to Peel New Adhesives From the Skin

An interventional study of Standard adhesive 1 and Standard adhesive 2 in Ileostomy - Stoma, sponsored by Coloplast A/S. Completed at 1 site in Denmark. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-01.

Sponsored by Coloplast A/S · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
5
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This study investigates the adhesion of new adhesives to the skin.

02

Conditions studied

  • Ileostomy - Stoma
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Have given written informed consent
  2. Be at least 18 years of age and have full legal capacity
  3. Have intact skin on the area used in the investigation

Exclusion criteria

Exclusion Criteria:

  1. Currently receiving or have within the past 2 months received radio- and/or chemotherapy
  2. Currently receiving or have within the past months received topical steroid treatment in the abdominal skin area or systemic steroid (tablet/injection) treatment.
  3. Are pregnant or breastfeeding
  4. Have dermatological problems in the abdominal area (assessed by investigator)
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
5 participants (actual)

Study arms

  • Experimental
    Testing of new adhesive strips

    Each subject will test six adhesive strips on pre-stripped skin. 1. Standard adhesive 1 2. Standard adhesive 2 3. LT-2 4. LT-21 5. LT-25 6. 33-20 The six strips are applied on the abdominal skin. The order of the adhesive strips on the skin is randomized. The subjects will change the adhesive strips at home and the adhesion of adhesive strips will be measured at 5 visits.

    Other: Standard adhesive 1 · Other: Standard adhesive 2 · Other: LT-2 · Other: LT-21 · Other: LT-25 · Other: 33-20

Interventions

  • OtherStandard adhesive 1

    This strip consists of a standard hydrocolloid adhesive found in ostomy devices

  • OtherStandard adhesive 2

    This strip consists of a standard hydrocolloid adhesive found in ostomy devices

  • OtherLT-2

    Newly developed adhesive

  • OtherLT-21

    Newly developed adhesive

  • OtherLT-25

    Newly developed adhesive

  • Other33-20

    Newly developed adhesive

05

What researchers measure

Primary outcomes

  1. Swelling of the adhesive

    1. Swelling of adhesive strips measured by weight (Difference between weight of strip before and after test)

    Time frame: 21 days

06

Study locations

1 site
  • Coloplast A/S
    Humlebæk, 3050, Denmark
07

Registry details

Key details

Study ID
NCT03289013
Lead sponsor
Coloplast A/S
Responsible party
Sponsor
First posted
Sep 20, 2017
Start date
Sep 11, 2017
Primary completion
Dec 21, 2017
Completion
Dec 21, 2017
Last update
Feb 1, 2018

Study contacts

Lene Feldskov
principal investigator · Head of preclinical department

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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