Comparison of Efficacy and Safety between Two Silver-Containing Dressings in the Treatment of Deep Partial-Thickness Thermal Burns: A Multicenter, Double-Blind, Non-Inferiority, Randomized Clinical Trial.

Abstract

Aims/Background Silver-containing dressings are commonly utilized in burns treatment by virtue of their excellent antibacterial properties. Further research is needed to determine the type of silver-containing dressing that is more effective and safer for burns treatment. Pyperbranched polyamide-Ag dressing (HBPs-Ag dressing) is a modified polyamide dressing with a uniform coating of the Amino-terminated hyperbranched polymer (HBP-NH₂)/Ag⁺ compound on its surface. This study aimed to evaluate the efficacy and safety of a silver ion-containing dressing (HBPs-Ag) for wound contact layer in the treatment of deep partial-thickness burns versus a silver-impregnated tulle dressing (Atrauman Ag). Methods This study was conducted between October 2019 to January 2021 at six sites in China. A total of 132 patients with deep partial-thickness burns (aged 18-65 years, injury occurring within 72 hours, burns <30% total burn surface area) were randomized 1:1 to HBPs-Ag group (study group) or Atrauman Ag group (control group). Data were obtained and analyzed, including total efficacy, wound healing rate, wound healing time, rate of negative bacterial culture from wound secretions, systemic response, skin or tissue irritation, local skin color changes, wound swelling, wound pain and adverse events. Results For partial thickness burns, the HBPs-Ag dressing was not inferior to Atrauman Ag dressing because the total efficiency of HBPs-Ag group (98.3%) was comparable to that of Atrauman Ag group (94.7%) (p > 0.05). There were no significant differences in efficacy, wound healing rate, wound healing time, and rate of negative bacterial culture from wound secretions between the two groups (p > 0.05). There were no statistical differences in all safety indicators tested between the two groups (p > 0.05). Silver was detected in the blood or urine of only 5 patients (3.79%). Conclusion The HBPs-Ag dressing was not inferior to Atrauman Ag dressing in deep partial-thickness burns treatment, with both of them showcasing comparable efficacy and safety. Clinical Trial Registration Chinese Clinical Trial Registry (ChiCTR2100049814).