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OpenTrials
Completed

NCT Number: NCT03289013

Assessement of the Peal Force Needed to Peel New Adhesives From the Skin

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

Completed

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Key information

Conditions

Ileostomy - Stoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Coloplast A/S

Humlebæk, 3050, Denmark

Who can participate

Healthy volunteers accepted: Yes

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

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)

Treatment and study plan

Standard adhesive 1

Other

This strip consists of a standard hydrocolloid adhesive found in ostomy devices

Standard adhesive 2

Other

This strip consists of a standard hydrocolloid adhesive found in ostomy devices

LT-2

Other

Newly developed adhesive

LT-21

Other

Newly developed adhesive

LT-25

Other

Newly developed adhesive

33-20

Other

Newly developed adhesive

Primary outcomes

  1. Swelling of the adhesive

    Time frame: 21 days

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

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Sep 20, 2017
Registry last updated
Feb 1, 2018

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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