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Evaluation of the Effect of Output on Newly Developed Adhesives

Not Applicable
Completed
Conditions
Ileostomy - Stoma
Registration Number
NCT03200418
Lead Sponsor
Coloplast A/S
Brief Summary

The study investigates the impact real output has on the adhesion of the adhesives.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
6
Inclusion Criteria
  1. Have given written informed consent
  2. Be at least 18 years of age and have full legal capacity
  3. Have had a stoma for more than one year
  4. Have intact skin on the area used in the evaluation
  5. Has a stoma 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 (tab-let/injection) treatment.
  3. Are pregnant or breastfeeding
  4. Having dermatological problems in the peristomal- or abdominal area (assessed by investigating scientist)
  5. Actively participating in other interventional clinical investigations or have previously participated in this investigation.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Trans epidermal water loss8 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 of water increases leading to a higher trans epidermal water loss. Thus, trans epidermal water loss is used to assess the damage to the skin.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Coloplast A/S

🇩🇰

Humlebaek, Denmark

Coloplast A/S
🇩🇰Humlebaek, Denmark

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