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

Coloplast

Status

Completed

Conditions

Wound Heal

Treatments

Device: Biatain Ag

Device: Cutimed Siltec Sorbact

Study type

Interventional

Funder types

Industry

Identifiers

NCT05923749

CP354

Details and patient eligibility

About

Approximately 178 patients with a venous leg ulcer will be included in the investigation evaluating wound healing. All subjects are randomized to one of two treatment arms with an intervention period of 4 weeks followed by a 8 week standard of care period.

Enrollment

180 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Exclusion criteria

Is pregnant or breastfeeding
Has wounds with exposed tendons, bones, fistulas. Or wounds with cavity, undermined or tunnelling
Has infection requiring antibiotics (also for other reasons than wound infection) OR has 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 (topical except for in the wound, inhalation, and stable systemic treat-ment up to 5 mg per day (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 combined immunodeficiency (SCID)
Has allergy towards silver or other dressing ingredients (including compression therapy)
Has wound with > 50% necrotic tissue
Treatment of wound with an anti-microbial wound dressing within the last 2 weeks