Surgical complications are reported in up to 10% of hip and knee arthroplasties. The incidence of postoperative surgical complications is influenced by co-morbidities, interoperative risk factors and duration and complexity of surgery. Join Dr. Carlos Higuera, Primary Investigator on a randomized control trial (RCT) that demonstrates significantly lower 90-day Surgical Site Complication (SSC) rates using ciNPT vs. standard of care.
thank you. Three. Um, for the invitation on and I'm going to talk about this study is a decrease 90 days. Surgical site complication rate with close incision. Negative pressure therapy after revision. Knee are two plastic a randomized controlled trial. I want to acknowledge my co authors from multiple different centers across the country. This is some important information about the Trevena product. All right. Study waas funded by K C. I. Part of three m company. So a little bit of background. We know that revision total near to plastic. He has a 15 fold increase in positive complication rates versus primary procedures. So we need efforts to be directed to mitigate some of these, especially surgical site complications that are very common. Um, they have bean prior reports assessing the efficacy off, uh, negative pressure technologies to try to mitigate these complications. However, the majority of these reports have been retrospective. Some of them have been a had a better genius cohort, including hip unease. Some inconsistent standard of care interventions on the sample size are relatively small. We actually did one of this pilot studies, uh, in the past. Um, about three years ago, that was published in the journal Far too plastic. So the Polina and Station Management system. It is important to clarify that has a new indication is uh, the first and only medical device indicated by the FDA. Toe eight in the reduction of suryamas and superficial surgical site infections. Eyes not eso directed to be used to treat infections or suryamas, and you can see the limitations here off the product. So the aims of the study where to evaluate the efficacy off this technology versus standard of care, which in this case was a silver impregnated, addressing and mitigating 90 day surgical site complication rates. The second aim was to investigate the effect of this technology versus a standard of care on healthcare utilization parameters after revision. Tonietto Plus and the last one was to try to establish the degree of improvement in patient reported outcomes in terms of pain and function. Produce was a perspective. Multi center was market open label randomized Clinical trial on the inclusion criteria patients that were older than 22 years of age revision total needs that were performed between December 2017 to August 2019, including one stage aseptic revisions or septic exchange removal of cement spacers, open reduction, internal fixation of pay, prosthetic fractures. However, we did not include the placement off a cement spacer. And finally patients had to demonstrate one or more high risk, UM, criteria. The high risk criteria included and increased B m I higher than 35 kg, uh, per meter square use of anticoagulants and the playlets ordered an aspirant current or previous diagnosis of peripheral vascular disease. Current tobacco use, lymphedema use of the immuno modulators, steroids or diagnosis of HIV history of malignancy, rheumatoid arthritis, renal failure or patient dialysis, malnutrition, labor disease, organ transplant, insulin dependent diabetes or prior infection of the operative side. We can see the distribution of the high risk mobility's off the subjects and roll the highest number of capabilities where, uh, the side of obesity on diabetes and you can see the distribution of the other ones on the graph exclusion criteria. Obviously, patients that were pregnant patients that need a revision within 30 days of a stage bilateral total need, um, current, the skin infection, localized skin cancer or hypersensitivity to the study components on the interventions again were to use the negative pressure. One therapy group That was the study group versus the control group where we use the standard of care, which was a commercially available silver impregnated dressing and the duration of treatment was the minimum off five days in both arms. Using Elektronik Web based algorithm, patients were randomized in a one on one basis toe one off the interventions in the operating room after conclusion of the revision procedure on wound closure to mitigate bias, and we use an IBM clinical development platform. The outcomes assess where the primary any occurrence off 90 day surgical site complication on all the exploratory outcomes included 90 days, surgical site infection, 90 days deep surgical site infection, 30 and 40 day incidents of surgical site complications, 90 days readmission and re operation, length of stay and the number of dressing changes the number off clinic home health and we have a physical therapy visits and the, uh, patient reported outcomes to evaluate pain and function using prom's or who scores. Apologize for the busy slide, but you can see the the concert workflow off the entire cohort. We have initially 364 patients enroll after exclusions of 70 patients. We were able to randomize 294 with equal number of patients 147 in each group, and some of those patients were lost and follow up on for, uh, some other reasons. The final analysis included 124 patients that completed the study, which meant on 84% follow up at 90 days versus 118 patients on the control group, which encompasses 80% follow up. We did an initial statistical analysis plan to enroll 440 patients. However, the study was designed to have an interim analysis indicated determination for a clear benefit for each one of the arms. Uh, then we did an intention to treat analysis and each group. Onda Safety Analysis said that depending on the allocated treatment, these were the characteristics of the population. About 124 patients and the study group versus 118 and the control group. The majority of patients were older, about 65 years of average. 60% of patients were female about the number of septic revisions where 29 the study group, which was about 20% of the of the group and 28 on the Standard of care group, which was about 20% as well. So then, really, this show that the random ization waas successful in terms of illuminate, eliminating as significant baseline differences in terms of demographics, com abilities on the type of diagnosis and the type of the revision. These air where our results 90 days. There was a significant lower number off surgical side complications on the study group. When we use the negative pressure dressing, as you can see, the percentage of complications in the study group was 3.4 versus about 14% on the control group and you could see the description of those complications. We found a clear difference in the aseptic revision population. However, despite the fact that we found the trend on the subject population of 10% off of surgical site complications and the study a study group on 17% of these complications on the control group, they was not a statistically significant difference. Then, when we look at that, our other outcomes again at 30 and $40.45 days, the number the difference in the complications was statistically significant between the study versus a control group. The length of state was a relatively shorter on the study group and the number of dressing changes was different as well. However, we did not find a difference in the number of clinical visits, home health visits or rehab of physical therapy visits. We did not find any difference in terms off pain and function, and the patient reported outcomes. Both groups show significant improvement and in terms off. When we did a safety analysis set, we found that there was a significant lower incidence of requiring more than one dressing change in the study group compared with a control group, and we did not find any significant difference and any reporting off adverse events between the groups. There's some limitations of this study. There was no blinding off outcome evaluation. The limited sample size, due to the premature discontinuation of the study, may have render on under power analysis to detect that significant difference on lower incidents. Events like in the septic revisions and we have some loss to follow up close toe 20%. But overall in conclusion, we can clearly see that the negative pressure group, after revision to run The Art of plastic was an effective intervention to decrease 90 days, surgical site complications and readmissions on the number of dressing changes without any significant difference in patient reported outcomes. Thank you. On behalf of three M plus K C. I thank you for joining today. If you have any further questions, please email them to medical education. Webinars at m m m dot com
