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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

Tracking Information
First Submitted Date  ICMJE November 1, 2017
First Posted Date  ICMJE November 6, 2017
Last Update Posted Date February 1, 2018
Actual Study Start Date  ICMJE September 27, 2017
Actual Primary Completion Date October 17, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 7, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 1, 2017)
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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of the Effect of Output on New Adhesives
Official Title  ICMJE The Evaluation of the Effect of Output on Newly Developed Adhesives
Brief Summary The study investigates the impact real output has on adhesion of new adhesives
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Ileostomy - Stoma
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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.

Interventions:
  • Other: Standard hydrocolloid adhesive patch
  • Other: LT-2
  • Other: LT-21
  • Other: 33-20
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 31, 2018)
5
Original Estimated Enrollment  ICMJE
 (submitted: November 1, 2017)
6
Actual Study Completion Date  ICMJE October 17, 2017
Actual Primary Completion Date October 17, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03331783
Other Study ID Numbers  ICMJE CP265_21_22
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Coloplast A/S
Study Sponsor  ICMJE Coloplast A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lene Feldskov Head of preclinical department
PRS Account Coloplast A/S
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP