A Pilot Evaluation of Newly Developed Adhesives and How They Are Impacted by Output

Coloplast A/S1 site in 1 country7 target enrollmentJanuary 10, 2018

ConditionsIleostomy - Stoma

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Ileostomy - Stoma
Sponsor: Coloplast A/S
Enrollment: 7
Locations: 1
Primary Endpoint: Trans epidermal water loss
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study investigated the performance of a new adhesive strip when impacted by output

Registry

clinicaltrials.gov

Start Date

January 10, 2018

End Date

January 22, 2018

Last Updated

8 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 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 test product (assessed by investigator)

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 investigator)
•Participating in other interventional clinical investigations or have previously participated in this investigation

Outcomes

Primary Outcomes

Trans epidermal water loss

Time Frame: 24 hours

trans epidermal water loss is a measure of the skins barrier function. There is always a oss of water from the skin due to evaporation. However, when the skin barrier is damaged this evaporation increases. Thus, trans epidermal water loss can be used to assess the skins barrier function