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OpenTrials
Completed

NCT Number: NCT03419013

Evaluation of the Performance of an Adhesive Strip

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

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: No

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 had an ileostomy for more than one year
  • Have intact skin on the area used in the evaluation
  • Has an ileostomy with a diameter up to (≤) 35 mm
  • Have a peristomal area accessible for application of test product (assessed by investigator)

Exclusion criteria

  • 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 investigator)
  • Participating in other interventional clinical investigations or have previously participated in this investigation

Treatment and study plan

New adhesive strip

Other

This strip is made of a newly developed adhesive

Primary outcomes

  1. Trans epidermal water loss

    Time frame: 24 hours

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

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 1, 2018
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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