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OpenTrials
Completed

NCT Number: NCT03331783

Assessment of the Effect of Output on New Adhesives

The study investigates the impact real output has on adhesion of new 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 a stoma for more than one year
  • Have intact skin on the area used in the evaluation
  • Has a stoma with a diameter up to (≤) 35 mm
  • Have a peristomal area accessible for application of patches/adhesive strips (assessed by investigating scientist)

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 peri-stomal- or abdominal area (assessed by investigating scientist)
  • Actively participating in other interventional clinical investigations or have previously participated in this investigation.

Treatment and study plan

Standard hydrocolloid adhesive patch

Other

This patch is made of a standard hydrocolloid adhesive

LT-2

Other

This patch is made of a new adhesive

LT-21

Other

This patch is made of a new adhesive

33-20

Other

This patch is made of a new adhesive

Primary outcomes

  1. Trans epidermal water loss

    Time frame: 8 hours

    The trans epidermal water loss is measured on the peristomal skin using a probe. The trans epidermal water loss is a measure for the skins barrier function. There is always a loss of water from the skin due to natural evaporation. However, when the skin barrier is damaged the evaporation will increase leading to an increase in the trans epidermal water loss.Thus, trans epidermal water loss is used to assess the damage to the skin. Maesurents are taken at time 0 and after 8 hours of output exposure to the skin.

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Official study title

The Evaluation of the Effect of Output on Newly Developed Adhesives

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Nov 6, 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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