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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03331783
Other study ID # CP265_21_22
Secondary ID
Status Completed
Phase N/A
First received November 1, 2017
Last updated January 31, 2018
Start date September 27, 2017
Est. completion date October 17, 2017

Study information

Verified date January 2018
Source Coloplast A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study investigates the impact real output has on adhesion of new adhesives


Recruitment information / eligibility

Status Completed
Enrollment 5
Est. completion date October 17, 2017
Est. primary completion date October 17, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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 patches/adhesive strips (assessed by investigating scientist)

Exclusion Criteria:

- 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 peri-stomal- or abdominal area (assessed by investigating scientist)

- Actively participating in other interventional clinical investigations or have previously participated in this investigation.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Standard hydrocolloid adhesive patch
This patch is made of a standard hydrocolloid adhesive
LT-2
This patch is made of a new adhesive
LT-21
This patch is made of a new adhesive
33-20
This patch is made of a new adhesive

Locations

Country Name City State
Denmark Coloplast A/S Humlebæk

Sponsors (1)

Lead Sponsor Collaborator
Coloplast A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Trans epidermal water loss The trans epidermal water loss is measured on the peristomal skin using a probe. The trans epidermal water loss is a measure for the skins barrier function. There is always a loss of water from the skin due to natural evaporation. However, when the skin barrier is damaged the evaporation will increase leading to an increase in the trans epidermal water loss.Thus, trans epidermal water loss is used to assess the damage to the skin. Maesurents are taken at time 0 and after 8 hours of output exposure to the skin. 8 hours
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