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OpenTrials
Completed

NCT Number: NCT05641168

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

The study investigates different adhesive materials on healthy and peristomal skin

Completed

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Key information

Conditions

Skin Abnormalities Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Coloplast Research Unit/Userlab

Humlebæk, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adhesive material

Other

Newly developed adhesive material

Standard adhesive material

Other

Standard adhesive material

Primary outcomes

  1. Adherent area

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

    Adherent area (assessed by photos of adhesive materials)

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Dec 7, 2022
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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