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
Condition: Venous Leg Ulcers; Mixed Leg Ulcers
MeSH terms: Varicose Ulcer; Leg Ulcer; Ulcer
Intervention: Mepilex Ag; Mepilex without Ag
Intervention description: Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.; Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 201.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Compare the efficacy of using an absorbent foam silver dressing (Mepilex Ag) versus the
      equivalent dressing without silver in subjects suffering from venous leg ulcer or mixed ulcer
      with an ABPI ≥ 0.8 and with inflammatory signs. Efficacy will be defined as absolute wound
      size reduction.
    

Eligibility criteria:

        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