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OpenTrials
Completed

NCT Number: NCT03000881

Evaluation of the Influence of Output on Skin Covered by Adhesives

The study investigates the impact real output has on peristomal skin covered by two different adhesives

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 adhesive strips

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 investigating scientist)
  • Participating in other interventional clinical investigations or have previously participated in this evaluation -

Treatment and study plan

standard adhesive

Other

This is a standard adhesive (hydrocolloid)

New adhesive strip

Other

This is a newly developed adhesive strip

Primary outcomes

  1. Trans Epidermal Water Loss

    Time frame: 8 hours

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 22, 2016
Registry last updated
May 31, 2017

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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