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 4 weeks 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) score with score of ≥3 points OR has at least three of the following clinical signs of bacterial 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 1 dressing 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-month intervention 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