Evaluating the Efficacy of an Absorbent Foam Dressing Containing Silver (Mepilex Ag) Versus the Same Dressing Without Silver Used on Subjects With Venous Leg Ulcers or Mixed Ulcers

Inclusion criteria

• Subjects with colonised/ local infection in a venous leg ulcer or mixed leg ulcer with an ABPI ≥ 0,8 and < 1.3
• A history of an appropriate compression therapy for at least 2 weeks prior to randomisation
• Subjects with colonised/local infection presenting with three of five following specified signs:

• pain between dressing changes
• exuding wounds
• erythema on peri-wound skin
• oedema
• odour
• An ulcer size of at least 4 cm2 and a maximum size witch could be covered by one investigational product of 15x15 cm.
• Ulcer duration 6 weeks to 1 year
• In case of multiple ulcers: target ulcer must be at least 3 cm distant from other ulcers.
• Both gender with an age ≥ 18 years
• Signed informed consent

Exclusion criteria

• > 10% necrotic (black) or fibrinous (yellow) tissue covering the wound bed
• Infected wounds in need of systemic antibiotic treatment
• Use of anti-microbial dressings or topical agents such as antiseptics, local antibiotics and steroids within 7 days from inclusion on the wound intended to be included
• Previous treatment with silver product 2 weeks prior to inclusion
• Previous treatment with MepilexAg® on the target ulcer
• Use of systemic antibiotics for any reason during the previous 7 days
• Venous surgery 2 weeks prior to inclusion or planned surgery within 8 weeks after inclusion
• Diagnosed underlying disease(s) (e.g. HIV/AIDS, cancer/malignancy and severe anaemia) judged by the investigator to be a potential interference in the wound evaluation
• Subjects with poorly controlled diabetes mellitus i.e. HbA1c >8%
• Subjects treated with systemic immunosuppressive or glucocorticosteroids, except subjects taking occasional doses or doses less than 10mg prednisolon/day or equivalent. Subjects inhaling glucocorticosteroids for asthma should not be excluded.
• Known allergy/hypersensitivity to any of the components of the investigation products.
• Subjects with physical and/or mental conditions that are not expected to comply with the investigation due to poor medical condition
• Participation in other clinical investigation(s) within 1 month prior to start of the investigation.
• Previously randomised to this investigation.
• Life expectance of the subject less than 3 months
• Pregnant or breast-feeding women