Evaluation of two fibrous wound dressings for the management of leg ulcers: results of a European randomised controlled trial (EARTH RCT).

OBJECTIVE To evaluate the performance (efficacy, safety and acceptability) of a new micro-adherent absorbent dressing (UrgoClean®) compared with a hydrofiber dressing (Aquacel®) in the local management of venous leg ulcers, in the debridement stage. METHOD A non-inferiority European randomised controlled clinical trial (RCT) was conducted in 37 centres, on patients presenting with venous or predominantly venous, mixed aetiology leg ulcers at their sloughy stage (with more than 70% of the wound bed covered with slough at baseline). Patients were followed over a 6-week period and assessed weekly. The primary judgement criteria was the relative regression of the wound surface area after the 6-week treatment period. Secondary endpoints were the relative reduction of sloughy tissue and the percentage of patients presenting with a debrided wound. RESULTS Altogether, 159 patients were randomised to either UrgoClean (test group; n=83) or Aquacel (control group; n=76) dressings. Regarding the wound healing process predictive factors (wound area, duration, ABPI value, recurrence), at baseline, the two groups were well balanced, for both wound and patient characteristics. Compression therapy was administered to both groups and after a median 42-day treatment period, the percentage of relative reduction of the wound surface area was very similar (-36.9% vs -35.4% in the UrgoClean and control groups, respectively). When considering the secondary criteria at week 6, the relative reduction of sloughy tissue was significantly higher in the UrgoClean group than in the control group (-65.3% vs -42,6%; p=0.013). The percentage of debrided wounds was also significantly higher in the test group (52.5% vs 35.1%; p=0.033). CONCLUSION This 'EARTH' RCT confirmed that the UrgoClean dressing has similar efficacy and safety compared to Aquacel. However, UrgoClean also showed better autolytic properties than the control group in the management of venous leg ulcers at the sloughy stage. The new UrgoClean dressing therefore represents a promising therapeutic option within the current range of autolytic dressings available. DECLARATION OF INTEREST This study was sponsored by a grant from the pharmaceutical company Laboratoires Urgo. S. Bohbot and O. Tacca are employees of Laboratoires Urgo. S. Meaume, J. Dissemond and G. Perceau have received monetary compensation as presenters for Laboratoires Urgo. Data management and statistical analyses were conducted independently by Vertical (Paris, France).