| 1 BackgroundSurgical site infection(SSI)is the most common nosocomial infection in surgery.There are many factors affecting wound infection,including preoperative skin preparation(commonly called skin preparation),intraoperative operation,postoperative dressing change,personal constitution and chronic diseases.Preoperative management of skin condition is the top priority in preventing infection.In particular,the ankle parts always has variety of pathogenic bacteria and fungi,because this part has many skin wrinkle、gaps and thick cuticle.A lot of patient itself already existed the fungus or bacterial infection sex disease,for example onychomycosis and tinea pedis is very common.If only treated by preoperative disinfection,it’s very difficult to make it sterile and has a high risk of infection.As an important part of preoperative skin preparation,reliable skin cleaning has been paid more and more attention by clinical surgeons.What kind of medicine should be used and how to clean skin is the topic of this study.At present,external application of Chinese medicine is widely used in clinical practice.Such as "administered drug through the intestines and skin"、"acupoint sticking" in internal medicine;"eliminating pus and slough"、"removing pus and promoting granulation"、"treatment of diabetic foot" in surgical;"external application for eliminating swelling"、"Chinese traditional medicine fumigation" in orthopedic.Among them,inhibit the bacteria by external application of Chinese medicine is a hot topic.Lots scholars have conducted a large number of pharmacological and in vitro experiments to prove that single traditional Chinese medicine and compound preparation have definite inhibition and killing effect on common pathogenic bacteria.By using external application of Chinese medicine for preoperative skin cleaning and preoperative infection prevention and treatment can reduce or even replace the application of antibiotics.There is a low rate of drug resistance by using Chinese medicine,so external application of Chinese medicine has important significance to reduce and control the application of antibiotics if it can be widely used in clinical.The main prescription of foot washing and bacteriostasis decoction is clear away heat and toxic material.No.1 prescription of external foot washing is a prescription approved by the joint science department of hospital of CACMS.It is mainly used for preoperative skin preparation for ankle surgery and has been used in clinical practice for nearly 20 years.It plays a good role in preventing incision infection.However.strict randomized controlled clinical trials have not been conducted to further verify its clinical efficacy.Preliminary in vitro bacteriostatic experiment results confirmed that its bacteriostatic effect is clear.2 ObjectivesThis study’s objectives:A randomized,positive drug control and blind evaluation method was adopted to develop the experimental program.Through the clinical trial study on the clinical bacteriostatic effect of foot washing prescription no.1,to verify the effectiveness of its bacteriostatic effect,to compare the antibacterial effect better or worse than the control group,and to evaluate the drug safety.The purpose is providing experimental basis for its clinical application in preoperative skin cleaning and reducing postoperative infection rate.3 Materials and MethodsIn this study,According to the inclusion and exclusion criteria,selected 60 subjects and their left and right feet were randomly included into the experimental group and the control group to fonn paired sample pairs,simulating the preoperative skin cleaning procedures.Samples were first collected after soapy cleaning.In the treatment group,foot washing prescription No.1(Rhubarb 20g.Rhizome Coptis 20g,Cortex Phellodendri 20g,Sophora Flavescens 20g,Dandelion 15g,Bunge Corydalis Herb 15g,Fructus Kochiae 15g,Common Cnidium Fruit 15g)was applied.The control group was treated with wuwei xiaodu drink plus or minus(Honeysuckle Flower 45g,Wild Chrysanthemum 18g,Purpleflower Bunge 18g,Root Of Nakedcaule Groundsel 18g and Dandelion 18g),and then collected the second samples after 30 minutes of foot soaking.Finally,the third sample was taken 12 hours after the sterile foot covers were placed in the bacteria chamber for bacterial culture,and the average number of bacterial colonies on the skin、the instant bactericidal rate,12-hour bactericidal rate and actual sterilization rate after 12 hours of medication were calculated.Skin reactions within 48 hours were observed and recorded to obtain the sensitization rate.Foot soaking,sampling and cultivation shall be carried out in strict accordance with the operator’s manual.(attached table D)Random grouping and blind evaluation:subjects were numbered according to the random number table and divided into groups A and B according to whether they were divisible by 2.The left foot of group A and the right foot of group B were selected as the experimental group.In the experiment,all samples were named with Numbers,and the personnel in the bacteria room did not know the grouping.The results were directly reported to the statistical commissioner,who completed the statistical analysis before decryption.See "quality control manual" for specific operations(attached table E).After statistical analysis,the experimental data of each group did not conform to the normal distribution,so the rank-sum test was used to compare the experimental data within and between groups.SPSS23.0 software package was used to process the data to drawn the conclusion.Finally,the drug safety was determined by the rate of sensitization reaction.4 Results4.1 Comparison of the average colony number between the two groups before soakingThe experimental group and the control group were cultured before soaking,and the average colony number was calculated.The two groups of data were regarded as two groups of independent samples,and the nonparametric test(rank sum test)of the independent samples was conducted to verify whether the paired samples were valid.At last,there was no significant statistical difference between the two groups of samples(Z≈0.173,p 0.862＞0.05),which verified the establishment of the paired samples.4.2 Instant bactericidal effect analysisThe average instant bactericidal rate of No.1 prescription of external foot washing in the experimental group was 84.77%,and that of the control group was 59.50%.There was a significant difference between the two groups(Z≈6.405.p≈0.000<0.01)through the paired sample rank sum test.4.3 Delayed bacteriostatic effect analysis12 hours after the application of the No.1 prescription of external foot washing,the average bacterial growth rate was 98.31%,the wuweixiaodu drink was227.2%.There is significant difference between the two groups of data(Z≈4.704,p≈0.000<0.01)through the paired sample rank sum test.The actual bactericidal rate of the tested foot was calculated after 12 hours and compared with before 12 hours.The average bactericidal rate was 74.83%in the experimental group and-8.27%in the control group.After statistical test,there is significant difference between the two groups of data(Z≈-6.706,p≈0.000<0.01).4.4 Drug safety analysisThe drug sensitization rate of No.1 prescription of foot washing and positive control group was 0 through observing within 48 hours after completing the experiment.5 ConclusionsThrough the above experiments and statistical analysis,the following conclusions are drawn:①Clear away heat and toxic and eliminating dampness prescription can effectively reduce the number of bacteria in the skin of ankle and foot,and the instant bacteriostasis effect of No.1 foot washing prescription is significantly higher than that addition and subtraction of antiphlogistic decoction of five drugs.②The delayed antibacterial effect of the experimental group 12 hours after soaking was significantly better than that of the control group.③the actual bactericidal rate of 12 hours in the experimental group was significantly higher than that in the control group.Therefore,the clinical bacteriostasis effect of the No.1 prescription of foot washing is clear and obviously better than control group,and at same time it is safe and reliable.So this skin cleaning method is worthy to promote in clinical. |
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