| [Objective] The aim of this study was to observe and compare the effects of Topical continuous diffusion of oxygen therapy combined with moist wound therapy group and moist wound therapy group on chronic wound by Randomized controlled trials and to observe and compare inflammatory response,neovascular density and tissue proliferative activity of chronic wound by immunohistochemical staining,providing a basis for clinical use of " Topical oxygen therapy" to improve the healing effect of wound tissue.[Method] In this study,patients with chronic wounds who came to the outpatient wound care center of Jinling Hospital Affiliated to Medical College of Nanjing University from January to December 2019 were selected as the screening population.Those who met the inclusion criteria and signed informed consent were selected as subjects.With the wound area reduction rate as the primary outcome,the sample size required for the study was 66 patients.The patients were randomly divided into intervention group(Topical continuous diffusion of oxygen therapy combined with moist wound therapy)and control group(moist wound therapy)by spss22.0 generating a random sequence,each group with 33 patients.All patients were followed for the treatment phase of 4 weeks,or until the wound closed,whichever event occurred first.Patients who wound was unhealed after 28 days will continue to receive follow-up treatment until healing or three months.The primary efficacy outcome was wound area reduction by 4 weeks.Secondary outcomes of rate of wound depth reduction,the rate of positive bacterial culture,wound temperature,exudate p H,the rate of ulcer closure,follow-up durability and the expression level of MMP-9,CD34,Ki67 are presented.In addition,this study also evaluated the safety of the two treatments.Spss 22.0 was used for statistical analysis.[Results] We enrolled 66 patients with chronic wounds,33 in each group,of which 30 completed the study in intervention group and 31 completed the study in control group.The data was processed according to the intention-to-treat principle.Finally,66 patients were included in FAS.PPS was included 61 patients into statistical analysis.We used two analysis set to analyze the main outcome and used PPS to analyze the secondary outcomes.Comparison of baseline FAS data between two groups of study subjects: There were no significant differences in demographic data including age,gender,BMI,diet,activity,and comorbidities(P>0.05);The wound data including wound type,duration,positive rate of bacterial culture,surrounding skin conditions,wound area,depth,wound temperature,exudate p H were no statistically significant differences(P>0.05).This indicates that study subjects have same baseline and are comparable.The results of the main outcome was that the difference in wound area reduction rate between two groups was not statistically significant at 14 d of treatment(P>0.05),and at 28 d of treatment,the difference in the reduction rate of wound area between two groups were statistically significant(P<0.05).Comparison of the secondary outcome:(1)The results of PPS showed that the difference in wound depth reduction rate was both statistically significant at 14 d,28d treatment(P<0.05).(2)The results of PPS showed that the positive rates of bacterial culture in intervention group and control group before treatment were 43.33%(13/30)48.39%(15/31).The positive rates of two groups decreased to 13.33%(4/30),32.26%(10/31)after 28 d,the difference was not statistically significant(P>0.05);(3)The results of PPS showed that when two groups were at same time level: there was no significant difference in temperature between two groups after 14 d of treatment(P>0.05),and temperature difference at 28 d treatment was significantly(P<0.05).The differences in temperature of two groups before treatment,14,28 d at any two time points were statistically significant(P<0.05);(4)When the two groups were at the same time level: the PPS result showed that at 14 d,28d of treatment,the intervention group PH was significantly lower than control group(P<0.05).When treatment factor was fixed: the PPS result was that there were significant differences in p H at any two time points in intervention group before treatment,14 dand 28d(P<0.05).The difference in p H of control group after 14 d was not statistically significant(P>0.05),while p H decreased significantly after 28 d of treatment compared with before and 14 d of treatment(P<0.05);(5)The result was that the follow-up closure rates of two groups were 80%(24/30),64.52%(20/31),and time to closure were 39.25±15.19 d,52.6±20.89 d.The PPS result was that the healing rates of two groups during intervention period were 26.67%(8/30),12.90%(4/31),which was also no significant difference(P>0.05);(6)A total of 4 patients were underwent biopsy,and expression levels of MMP-9,CD34 and Ki67 were observed before and 14 d after treatment.No adverse event occurred during intervention period in two groups.[Conclusion] During 28 days intervention period,the intervention group can promote chronic wound healing,which was speculated that it was associated with intervention group reduced inflammatory response,promote neovascularization and tissue proliferation activity.While this needs to be confirmed by further large sample studies.The two groups both are safe wound treatment techniques. |
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