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Assessment of the Effect of Output on New Adhesives

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03331783
Recruitment Status : Completed
First Posted : November 6, 2017
Last Update Posted : February 1, 2018
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S

Brief Summary:
The study investigates the impact real output has on adhesion of new adhesives

Condition or disease Intervention/treatment Phase
Ileostomy - Stoma Other: Standard hydrocolloid adhesive patch Other: LT-2 Other: LT-21 Other: 33-20 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Evaluation of the Effect of Output on Newly Developed Adhesives
Actual Study Start Date : September 27, 2017
Actual Primary Completion Date : October 17, 2017
Actual Study Completion Date : October 17, 2017

Arm Intervention/treatment
Experimental: Test of new adhesive strips

On the peristomal skin 4 different patches are applied to the skin (Standard hydrocolloid adhesive patch; LT-2, LT21 and 33-20. There is a bag welded to each patch. Tthe bag contains real output.

The difference between the four patches is that they are made of four different adhesives.

The primary endpoint is measured after 8 hours and 24 hours.

Other: Standard hydrocolloid adhesive patch
This patch is made of a standard hydrocolloid adhesive

Other: LT-2
This patch is made of a new adhesive

Other: LT-21
This patch is made of a new adhesive

Other: 33-20
This patch is made of a new adhesive




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03331783


Locations
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Denmark
Coloplast A/S
Humlebæk, Denmark, 3050
Sponsors and Collaborators
Coloplast A/S
Investigators
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Principal Investigator: Lene Feldskov Head of preclinical department
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Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT03331783    
Other Study ID Numbers: CP265_21_22
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No