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

Coloplast A/S1 site in 1 country6 target enrollmentAugust 8, 2017

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: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

August 8, 2017

End Date

September 23, 2017

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 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 adhesive strips (assessed by investigating scientist)

Exclusion Criteria

•1 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.

Outcomes

Primary Outcomes

Trans epidermal water loss

Time Frame: 8 hours

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