Evaluation of the Effect of Output on Skin Covered by a New Adhesive

Overview

The study investigates the impact real output has on peristomal skin covered by a newly developed adhesive and a standard adhesive

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 9, 2017

Interventions

  • Other: New adhesive strip
    • This is a strip made of a newly developed adhesive. This adhesive might in the future be part of an ostomy product.
  • Other: Standard adhesive strip
    • this is a standard adhesive strip (hydrocolloid). This adhesive is currently used in marketed ostomy devices.

Arms, Groups and Cohorts

  • Experimental: Cohort 9
    • This is a sub-study testing the effect of real output applied under two adhesive strips on the skin. Standard adhesive strip and a strip with a newly developed adhesive (new adhesive strip)

Clinical Trial Outcome Measures

Primary Measures

  • Trans epidermal water loss
    • Time Frame: 6 hours
    • The condition of the skin is measure by trans epidermal water loss after removing the adhesive strip.

Participating in This Clinical Trial

Inclusion Criteria

1. Have given written informed consent 2. Be at least 18 years of age and have full legal capacity 3. Have had an ileostomy for more than one year 4. Have intact skin on the area used in the evaluation 5. Has an ileostomy with a diameter up to (≤) 35 mm 6. Have a peristomal area accessible for application of patches/adhesive strips (assessed by investigating scientist) - Exclusion Criteria:

1. Currently receiving or have within the past 2 month received radio- and/or chemotherapy 2. Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment. 3. Are pregnant or breastfeeding 4. Having dermatological problems in the peristomal- or abdominal area (assessed by investigating scientist) 5. Participating in other interventional clinical investigations or have previously participated in this evaluation

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Coloplast A/S
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Lene F Nielsen, M. Sci, Principal Investigator, Head of preclinical department

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