Efficacy and safety of chitosan wound dressing for deep second-degree burn:a prospective, single-blind, randomized controlled trial / 中国组织工程研究

ABSTRACT

BACKGROUND: Chitosan wound dressing has been extensively used in the treatment of wounds and burns, not only because of its bacteriastasis, hemostasis and promoting the wound healing, but also its good biocompatibility,biodegradability and biological functions.OBJECTIVE: To evaluate the efficacy and safety of chitosan wound dressing for deep second-degree burn, thereby providing clinical basis for its registration.METHODS: Sixty patients with deep second-degree burn were randomly allotted to two groups, and then subjected to the external application of chitosan wound dressing (experimental group) or chitosan biomedical dressing (control group),respectively. Then, the therapeutic efficacy was evaluated through healing time, recovering rate and pain scores, and the safety was evaluated through the incidence of adverse reactions and laboratory indexes before and after treatment.RESULTS AND CONCLUSION: There were no significant differences in the wound healing time [(21.23±6.84) days vs.(23.77±4.26) days], recovery rate and pain scores between the experimental and control groups at 14, 21 and 28 days after treatment (P > 0.05). The blood routine, liver function and kidney function indexes before and after treatment did not differ significantly between groups. Additionally, neither adverse nor severe adverse events occurred in the two groups.These results indicate that the therapeutic efficacy and safety of the chitosan wound dressing are equivalent to the control product in the treatment of deep second-degree burn.