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

Molnlycke Health Care

Status and phase: Completed; Phase 4

Conditions: Venous Leg Ulcers; Mixed Leg Ulcers

Treatments: Device: Mepilex without Ag; Device: Mepilex Ag

Study type: Interventional

Funder types: Industry

Identifiers

NCT01036438

PUMA 416

Details and patient eligibility

About

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.

Enrollment: 201 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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201 participants in 2 patient groups, including a placebo group

Mepilex product

Placebo Comparator group

Treatment:

Device: Mepilex without Ag

Mepilex Ag

Active Comparator group

Treatment:

Device: Mepilex Ag