A RCT Evaluating the Clinical Benefit of a Silver Dressing in the Treatment of Venous Leg Ulcers

Inclusion Criteria:

• Has signed informed consent

• Is above 18 years of age or above and has full legal capacity

• Has venous leg ulcer (C6 of the CEAP classification) with a duration longer than 4weeks but no longer than 5 years

• Has acceptance of compression bandages

• Has a wound at risk of infection based on WAR (wounds at risk of infection) scorewith score of ≥3 points OR has at least three of the following clinical signs ofbacterial contamination based on the Therapeutic index for local infections (TILI)score:

• Erythema to surrounding skin

• Heat

• Oedema, induration or swelling

• Spontaneous pain or pressure pain

• Stalled wound healing

• Increase and/or change of color or smell of exudate

• Has wound area of min 1x1 cm and max 10x10 cm

• Has wound with depth of max 2 cm

• Has wound with medium to high level of exudate (but should not require more than 1dressing change/day)

• Has ankle-brachial pressure (ABI) ≥0.8 AND, for patients with diabetes mellitus,additional biphasic Doppler signal up to the ankle

• Ability (assessed by the investigator) and willingness to adhere to a 1-monthintervention period

• For patients with diabetes, has HbA1c ≤ 10%/≤ 86 mmol/mol, measured within the last 3 months prior to inclusion

• Should be able to follow the study protocol with the prescribed cleansing product (NaCl) and dressing

Exclusion Criteria:

• Is pregnant or breastfeeding

• Has wounds with exposed tendons, bones, fistulas. Or wounds with cavity, underminedor tunnelling

• Has infection requiring antibiotics (also for other reasons than wound infection) ORhas received antibiotics within the last 1 week before inclusion

• Has been receiving the following medical treatment within the last 4 weeks:immunosup-pression, immunomodulating, cytostatic medi-cation or corticoids (topicalexcept for in the wound, inhalation, and stable systemic treat-ment up to 5 mg perday (stable defined as minimum 4 weeks) is allowed

• Has a systemic hematological disease

• Has renal insufficiency requiring dialysis

• Has advanced heart failure NYHA III/IV

• Has a psychiatric illness that inhibits compliance with the study protocol

• Has severe congenital immunodeficiency such agammaglobulinemia, severe combinedimmunodeficiency (SCID)

• Has allergy towards silver or other dressing ingredients (including compressiontherapy)

• Has wound with > 50% necrotic tissue

• Treatment of wound with an anti-microbial wound dressing within the last 2 weeks