The Effects Of Two Different Closed Negative Pressure Drainage Materials On The Treatment Of Negative Pressure Wound Therapy

BackgroundVacuum sealing drainage(VSD)has been widely used in the treatment of acute and chronic wounds and achieved significant clinical effects since its application.At present,there are many VSD materials for clinical selection.However,there are few comparative studies on the clinical efficacy and safety of different VSD materials.Therefore,there is still a lack of reliable experimental data to support the selection of these different materials in clinical treatment.ObjectivesThrough the multilateral comparison and analysis of the VSD modes with the same dressing material but different drainage devices,the clinic VSD al effectiveness and safety of VSD(PU sucker type)was evaluated and the difference and similarity between the two different devices was analyzed for providing reliable reference data for the clinical application of NPWT.Methods1.This study was a randomized,non-inferiority trial.2.One hundred and thirty-two hospitalized patients requiring VSD treatment were randomly divided into two groups: Group A was treated with a VSD system(PU sucker type),and Group B was treated with a VSD kit(II-PU straw type).The effective rate within 14 days after treatment was taken as the main efficacy index;pain score was used as secondary efficacy evaluation indicators;adverse events/reaction rates,laboratory tests(blood routine,liver function,the coagulation rate and the incidence of complications were used as safety evaluation indicators,to evaluate the clinical effectiveness and safety of the closed negative pressure drainage wound care system.3.Statistical analyses were performed using SPSS 20.0.Full analysis data set(FAS),protocol compliance set(PPS),and safety data set(SS)were used to evaluate the therapeutic efficacy(primary efficacy and secondary efficacy)and safety of this study.Both FAS and PPS were used for validity analysis.The main data set of security evaluation was SS.The statistical methods used in this study were general descriptive analysis,group t-test,CMH chi-square test and rank-sum test.The quantitative Indicators were described by mean and standard deviation.The qualitative indicators were described by the number and percentage of each category.Differences with a P value of 0.05 or less were considered to be statistically significant,and all P values were two-sided.ResultsA total of 132 patients were included in the FAS set(66 in the Group A and 66 in Group B),and 128 patients included in the PPS set(65 in Group A and 63 in Group B).All efficacy indexes were analyzed by using FAS and PPS,and the PPS results were basically consistent with the FAS results.1.Main efficacy indexThe effective rates within 14 days after treatment were 100.00% in Group A vs Group B,P>0.05 was found between the two groups in the CMH chi-square test.The difference was not statistically significant,which proved that Group A was not inferior to Group B.2.Secondary efficacy indicatorsThere was no statistically significant difference between Group A and Group B at 10±3 days after treatment(P>0.05),indicating that the product of Group A was not inferior to the one of Group B in alleviating the pain of the patients.After treatment,compared with before treatment,the pain scores of patients in Group A and Group B decreased significantly(P<0.05)at 10±3 days after treatment,indicating that the product of both group could alleviate the pain of patients.3.Safety evaluation 3.1 Laboratory testThere was no statistical difference between group A and group B in laboratory indexes(blood routine,liver function and coagulation)after treatment.3.2 The complicationsIn group A,there were 1 case of skin lesions and 5 cases of drainage channel obstruction,accounting for 1.5% and 7.5% respectively;In group B,there were 1 case of skin lesions and 14 cases of drainage channel obstruction,accounting for 1.5% and 21.2% respectively.According to chi-square test,the incidence of drainage channel blockage in group A was lower than that in group B,and the difference was statistically significant(P < 0.05).3.3 Adverse events found in clinical trials and their managementDuring the study period,the incidence of adverse events in Group A and Group B was 13.6%(9/66)and 15.2%(10/66),respectively.In Group A,1 out of 9 adverse events may be related to the test product,with an incidence of 1.5%(1/66).In Group B,3 out of 10 adverse events may be related to the test product,with an incidence of 4.5%(3/66).All the above adverse events were untreated or recovered after symptomatic support treatment.Conclusions1.The therapeutic effective rates were 100.00% in both of the two kinds of VSD material within 14 days after treatment in our research,the effective rate of the VSD system(PU sucker type)is not inferior to the VSD kit(?-type PU straw).2.There was no significant difference between the VSD system(PU sucker type)and the VSD kit(II-PU)according to the pain score.Both systems had appeared drainage tube blocking,the ?-PU type had a higher incidence than PU sucker type,but both had less complications happened such as bleeding under high negative pressure drainage,effusion under film,lesions and skin lesion,also has not occurred adverse events related to the product.3.The efficacy and safety of VSD(PU sucker type)for clinical vacuum sealing and drainage treatment can be verified,which can provide a new treatment option for patients who need to closed negative pressure drainage.In combination with clinical practice,medical staff can individually select external suction cup type or built-in straw type negative pressure closed drainage material according to different conditions of different patients,thereby solving patients' suffering,reducing economic burden and improving quality of life.