A non-inferiority study to compare the effect of silica gel fiber dressing with alginate dressing on healing of venous leg ulcers.

BACKGROUND:Silica gel fiber (SGF) dressing is a novel patch for wound healing. OBJECTIVE:To compare the efficacy and safety of SGF dressing with alginate dressing in local treatment of venous leg ulcers. METHODS:Patients with venous leg ulcers who had undergone effective treatment of venous hypertension and debridement were randomized to receive wound care with either SGF dressing or alginate dressing for 4 weeks. Wounds were assessed weekly during the first 4 weeks and then every 2 weeks until the 8th week. The primary endpoint was the efficacy rate. Secondary endpoints included ulcer area reduction rate, healing rate, frequency of dressing changes, pain score, patient satisfaction, and treatment-related adverse events. RESULTS:A total of 130 patients were enrolled, 67 treated with SGF and 63 with alginate dressing, and the efficacy rates were 89.6% (SGF group) and 84.1% (alginate group). SGF induced a higher "no pain" rate than alginate at week 2 (61.4% vs 43.5%) and week 3 (67.6% vs 53.1%), and a higher "highly satisfied" rate at week 4 (83.3% vs 78.8%) and week 8 (75% vs 59.1%). Markedly fewer dressing changes were required in the SGF group. CONCLUSIONS:SGF dressing is non-inferior to alginate dressing in treating venous leg ulcers. It even substantially decreased the frequency of dressing changes when compared with alginate dressing.