Open Multi-centre Investigation to Evaluate Signs and Symptoms of Local Inflammation/Infection on Chronic Ulcers and Partial Thickness Burns When Using Mepilex Border Ag as an Anti-microbial Wound Dressing

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the change in signs of inflammation/local infection when Mepilex Border Ag is used in normal clinical practice when used on chronic ulcers (venous leg, diabetic foot and pressure ulcers) and partial thickness burns in need* of topical antimicrobial treatment according to the physician.

Detailed Description
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The investigation is designed as an open, non-controlled, post-marketing clinical follow-up. Subjects with chronic ulcers or partial thickness burns (including donor sites) at 2 sites will be included. Each subject with a chronic ulcer will be seen once a week for a maximum of 4 weeks or until desired treatment effect is obtained, whichever occurs earlier. Each subject with a partial thickness burn/donor site will be followed once a week for a maximum of 3 weeks or until desired treatment effect is obtained, whichever occurs earlier. All dressing changes will be done according to clinical routine practices and will follow IFU (instruction for use)

Official Title
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Open Multi-centre Investigation to Evaluate Signs and Symptoms of Local Inflammation/Infection on Chronic Ulcers and Partial Thickness Burns When Using Mepilex Border Ag as an Anti-microbial Wound Dressing

Conditions
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Inflammation, Burns, Ulcers

Intervention / Treatment
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* Device: Mepilex Border Ag


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject with a chronic ulcer (venous leg, diabetic foot and pressure ulcers) or a partial thickness burn where an antimicrobial action is indicated* as judged by the investigator Male or female, 18 years and above, both in- and out-patients Signed Informed Consent Form Exclusion Criteria: Wound size equal to or above 9.5x15cm for the wound/burn to be included in the investigation Subject not expected to follow the investigation procedures TBSA > 10% (partial thickness burns only) HbA1C value > 7.2. (To be measured if BMI > 30) Pregnant and breastfeeding women Pressure ulcers deeper than stage 3 Deep pressure ulcers in need of a filler Subjects with known sensitivity to silver or any other dressing materials Subjects receiving radiation treatment or examinations e.g. X-ray, ultrasound, diathermy or Magnetic Resonance Imaging Subjects using oxidising agents such as hypochlorite solutions or hydrogen peroxide Subjects previously included in this investigation Subjects included in other ongoing clinical investigation at present or during the past 30 days

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Mepilex Border Ag<br>Non comparative study with one active arm - Mepilex Border Ag | Device: Mepilex Border Ag<br>* Mepilex Border Ag may be left in place for up to seven days, depending on the condition.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound Are at Baseline |  | Baseline | 
| Wound Area at Visit 2 | At each visit the wound length and width is measured and calculated in cm2. | After one week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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The change in signs of inflammation/local infection, To evaluate the comfort, conformability,, Pain during wear