A randomized comparative trial between Acticoat and SD-Ag in the treatment of residual burn wounds, including safety analysis.

OBJECTIVE: To investigate and evaluate the clinical efficacy and safety of Acticoat with nanocrystalline silver for external use on the management of the residual wounds post-burn.

METHODS: One hundred and sixty-six wounds of 98 burn patients were enrolled and divided into Acticoat group and silver sulfadiazine group in the multi-center randomized clinical trial. Acticoat was used as the treated group for those who have redness, swelling, and excessive secretion ("heavy" exudates) in the wound, Acticoat was changed once a day. When there is not much secretion in the wound, or redness and swelling were not obvious, the dressings were changed once every 3 days. Silver sulfadiazine (SD-Ag) was used as control group, which was treated under the usual clinical routine. Healing time was observed up to 20 days. Healing percentage on the 15th day after treatment was determined.

RESULTS: Healing time was 12.42+/-5.40 days after the application of Acticoat. This was significantly shorter than that of control wounds. The wounds of the trial group healed nearly 3.35 days earlier than the control ones. Healing percentage at 15 days in the trial wounds was 97.37%, which was higher than the control, but there was no significant difference between them. The bacterial clearance rate of the Acticoat group on the 6th and 12th day post-treatment was 16.67 and 26.67%, respectively, which was significantly higher than the control.

CONCLUSIONS: Acticoat with nanocrystalline silver promotes the healing process of residual wounds post-burn effectively. No adverse reaction of Acticoat was found during the study.