A Pilot Evaluation of Newly Developed Adhesives and How They Are Impacted by Out-put

Coloplast A/S1 site in 1 country6 target enrollmentJanuary 25, 2018

ConditionsIleostomy - Stoma

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Ileostomy - Stoma
Sponsor: Coloplast A/S
Enrollment: 6
Locations: 1
Primary Endpoint: trans epidermal water loss
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study investigates the performance of a new adhesive

Registry

clinicaltrials.gov

Start Date

January 25, 2018

End Date

February 20, 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Coloplast A/S

Responsible Party

Sponsor

Eligibility Criteria

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 peristomal- or abdominal area (assessed by investigating scientist)
•Actively participating in other interventional clinical investigations or have previously participated in this investigation.
•Exception: Participation in other Coloplast in-house clinical investigations are accepted under the circumstances of otherwise complying with the Inclusion and exclusion criteria of this protocol (CP265)

Outcomes

Primary Outcomes

trans epidermal water loss

Time Frame: 24 hours

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 evaporation. When the skin barrier is damaged the evaporation of water increases. Thus, trans epidermal water loss can be used to assess skin damage