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Clinical Trials/NCT05641168
NCT05641168
Completed
Not Applicable

A Pilot Evaluation Exploring New Adhesive Materials and Their Ability to Adhere to Abdominal and Peristomal Skin

Coloplast A/S1 site in 1 country114 target enrollmentApril 28, 2021
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ConditionsSkin Abnormalities

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Skin Abnormalities
Sponsor
Coloplast A/S
Enrollment
114
Locations
1
Primary Endpoint
Adherent area
Status
Completed
Last Updated
8 months ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The study investigates different adhesive materials on healthy and peristomal skin

Registry
clinicaltrials.gov
Start Date
April 28, 2021
End Date
May 30, 2024
Last Updated
8 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Has given written consent
  • •Be at least 18 years of age and have full legal capacity
  • •Have had a colostomy/ileostomy/urostomy for more than one year (for stoma patients) Have suitable peristomal skin area (assessed by investigator) (for stoma patients)

Exclusion Criteria

  • •Currently receiving or have within the past 2 months received radio- and/or chemotherapy
  • •Currently receiving or have within the past month received topical steroid treatment in the abdominal skin area or systemic steroid (tablet/injection) treatment
  • •Are pregnant or breastfeeding
  • •Having dermatological problems in the abdominal area (assessed by investigator)
  • •Participate in other clinical investigations. Exception: Participation in other Coloplast sponsored clinical investigations is accepted under the circumstances that the subject has paused the activities in the investigation and are otherwise complying with the inclusion and exclusion criteria of this protocol

Outcomes

Primary Outcomes

Adherent area

Time Frame: At every material change throughout the study, an average of 1 week

Adherent area (assessed by photos of adhesive materials)

Study Sites (1)

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