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Clinical Trials/NCT03289013
NCT03289013
Completed
Not Applicable

A Pilot Evaluation Exploring New Adhesive Materials and Their Ability to Handle Moisture From Abdominal and Peristomal Skin

Coloplast A/S1 site in 1 country5 target enrollmentSeptember 11, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ileostomy - Stoma
Sponsor
Coloplast A/S
Enrollment
5
Locations
1
Primary Endpoint
Swelling of the adhesive
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
September 11, 2017
End Date
December 21, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

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 intact skin on the area used in the investigation

Exclusion Criteria

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

Outcomes

Primary Outcomes

Swelling of the adhesive

Time Frame: 21 days

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

Study Sites (1)

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