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Investigating the Adhesion of New Adhesive to the Skin

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: NCT03439176
Recruitment Status : Enrolling by invitation
First Posted : February 20, 2018
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S

Brief Summary:
The adhesion of the new adhesive strips is investigated on healthy volunteers

Condition or disease Intervention/treatment Phase
Ileostomy - Stoma Other: Standard adhesive 1 Other: Standard adhesive 2 Other: PL4 Other: PL16-L Not Applicable

Detailed Description:

Inclusion visit:

  • Introduction to the study
  • Inclusion in study
  • Baseline information is obtained
  • Instruct subject to pre-strip of abdominal skin

Test visits 1-25 (up to maximum 25 visits per subject. (1-3 days after pre-stripping the abdominal skin):

  • Baseline measurements are conducted on both sides of the stomach (TEWL, hydration, erythema, pH - 3 repeated measurements under each adhesive strip area (upper, middle and bottom of adhesive strip)
  • Potential wetting of skin - shower/bicycle exercise (max 60 minutes) and after-wetting baseline measurements are conducted (TEWL, hydration, erythema, pH - 3 times/strips (upper, middle and bottom of adhesive strip))
  • Adhesive strips are weighted and applied
  • Potential shower/bicycle exercise (max 60 minutes)
  • Adhesive strips are removed at pre-defined timeslots (peel force measured)
  • Discomfort when strip was peeled of is evaluated by subject (VAS)
  • Measurements are conducted (TEWL, hydration, erythema, pH - 3 times/strips (upper, middle and bottom of adhesive strip))
  • Acclimatization ½
  • Measurements are conducted (TEWL, hydration, erythema, pH - 3 times/strips (upper, middle and bottom of adhesive strip))
  • Adhesive strips are weighed
  • Photo of adhesive strips

The subjects can be asked to apply and change strips every 24 hours between two test visits but for a maximum of 10 days between two visits. The strips should be applied at the same place every time.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Pilot Evaluation Exploring New Adhesive Materials and Their Ability to Handle Moisture From Abdominal and Peristomal Skin
Actual Study Start Date : January 15, 2018
Actual Primary Completion Date : February 15, 2018
Estimated Study Completion Date : June 30, 2020

Arm Intervention/treatment
Experimental: Test of new adhesive strips

The subjects will test adhesives strips made of 4 different adhesives:

Standard adhesive 1 Standard adhesive 2 PL4 PL16-L

Other: Standard adhesive 1
This strip contains a standard hydrocolloid adhesive found in ostomy devices

Other: Standard adhesive 2
This strip contains a standard hydrocolloid adhesive found in ostomy devices

Other: PL4
This strip contains a new adhesive

Other: PL16-L
This strip contains a new adhesive




Primary Outcome Measures :
  1. Swelling of the adhesive [ Time Frame: 24 hours ]
    Swelling of adhesive strips measured by weight (difference between the weight of the strip before and after use)



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:   Yes
Criteria

Inclusion Criteria:

  1. Have given written informed consent
  2. Be at least 18 years of age and have full legal capacity
  3. Have intact skin on the area used in the investigation

Exclusion Criteria:

  1. Currently receiving or have within the past 2 months received radio- and/or chemotherapy
  2. Currently receiving or have within the past months received topical steroid treatment in the abdominal skin area or systemic steroid (tablet/injection) treatment.
  3. Are pregnant or breastfeeding
  4. Have dermatological problems in the abdominal area (assessed by investigator)

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): NCT03439176


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 F Nielsen Head of the pre-clinical department
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Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT03439176    
Other Study ID Numbers: CP267_3_5
First Posted: February 20, 2018    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020

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