The Efficacy And Safety Evaluation Of Tuojiagao Treatment Of Deep Ⅱ Degree Burn Wounds

Background: With the development of industrialization,burn injury becomes a major cause of death and disability worldwide.The main factors of burn injury are from a variety of physical,chemical and biological factors.The treatment of burn injury is a complex system process,among which,the treatment of burn wound is very important.Different treatments of wound lead to different results of wound healing,and then affect the prognosis of patients suffered from burn injury.Many kinds of medicines can be used in the treatment of burn wound,among which,Tuojiagao,a traditional Chinese medicine,which was made by our hospital and was of low price,has been used in clinic for many years.However,there is a lack of normative research on its efficacy and safety.Objective: Evaluate the efficacy and safety of Tuojiagao in the treatment of clinical deep Ⅱ degree burn wounds.Methods: A total of 42 patients with deep Ⅱ burn were collected as subjects,which were from Burn Surgery outpatient in Changhai Hospital from April to September in 2015.Randomized,single blind,blind,positive,single center,and non inferiority designs were used in clinical trials.Each subject wound area is divided into two roughly equal two "sub-bed",respectively,as the test group and control group.The wound in the test group was treated with Tuojiagao and the control group was treated with Intrasite Gel.The first wound observation was recorded 3 days after the first dose.Then We recorded the wound healing time,wound healing rate,wound infection rate of infection and pain during the visual analogue score every 2 days to evaluate the efficacy of Tuojiagao.We tested the subjects’ blood,urine and blood biochemistry before the first medication and wound healing and we recorded whether there was a rash,dipping,itching,and other adverse events in the medication area during the course of treatment.The results were used to evaluate the safety of Tuojiagao.Results: The average healing time was 13.8 days in the experimental group and 14.1 days in the control group,the difference was not statistically significant(p> 0.05).On the 14 th day,22 cases(52.4%)were healed in the experimental group and 91.6 ± 11.8% in the wound healing area.The control group healed 20 cases(47.6%)and the wound healing area ratio was 91.3 ± 11.9%.On the 21 st day,41 cases(97.6%)were treated in the experimental group and 99.8 ± 1.2% in the wound healing area.The control group healed 41 cases(97.6%)and the wound healing area ratio was 99.8 ± 1.1%.There was no significant difference in the wound healing area between the two groups on day 14 and day 21(p> 0.05).There were 0 cases in the experimental group and 0 cases in the control group.The infection rate was 0.There was no significant difference between the two groups.There was no significant difference between the experimental group and the control group in the pain caused by the previous three dressing(n = 42,p> 0.05)Conclusion: Tuojiagao was used to treat the deep Ⅱ degree burn wounds,its efficacy and safety is not weaker than Intrasite Gel.It is suggested that this drug can be used as an important clinical drug for treating deep Ⅱ degree burns.This study will provide important social and economic value for the treatment of burn wounds.