Join us for a unique opportunity to learn about the role of the 3M solutions used in the perioperative pathway to help reduce the risk of costly complications associated with surgery and to gain a deeper understanding of key evidence focused on patient preparation, temperature management, and surgical incision management.
By the end of this webinar, attendees will be able to:
• Examine the role of 3M solutions across key touchpoints in the perioperative pathway to reduce the risk of costly complications associated with surgery
• Gain a deeper understanding of key evidence focused on patient preparation, temperature management, and surgical incision management.
Hello. Thank you for joining three M. Symposia today preventing complications across the peri operative pathway evidence based practices to minimize surgical site complications and optimize clinical outcomes. I will be your speaker today. My name is Amy Law. I lead global health economics, Outcomes Research and Market Access for three Medical Solutions Division. As part of this role is my job to create evidence to demonstrate the health economic value proposition of our therapies and how they impact complications or cost to treat such as surgical site complications. Today I will be discussing a few elements in the three and portfolio in the areas of patient preparation, temperature management and surgical incision management. Just some important safety information. Prior to use of any of the products discussed today, please refer to the safety information and the instructions for use which are available from your local representative or on the three and website. Please note that the purpose of this presentation is really to highlight different pieces of evidence and literature on different therapies. These studies are not meant to be all inclusive. They were selected by me and they are the formation of some of the programs were developing and some of the research that we're conducting now. So this is not meant to be all inclusive. Additionally, I'll be moving fairly quickly. So if you would like a copy of any of the publications that I referenced, please reach out and send an inquiry to our medical publications department. Additionally please take a moment to review the indications for use and limitations of any of the therapies discussed today. They are also available on the three M. Website. I will be specifically discussing the indications for use and how they have changed for Cavenagh therapy, which is presented here. Okay, so let's begin. So since K. CI and three M. Have joined together, we now have many different products in our portfolio that may be part of a comprehensive program to reduce surgical site complications. Today, I'm going to discuss the areas that are highlighted here simply because that's where we're doing some of our research. Now. Historically, my studies or my team studies have all been looking at adding one intervention and what's the impact on quality measures such as surgical site complication for the impact on the total cost to treat of one individual intervention. And now we're starting to look at programs or bundled solutions and what's the impact of these before and after introducing multiple products at once. So I'll just discuss some of the ones that we're looking at. Currently we're going to start with nasal decolonization or nasal anti sepsis. Specifically looking at microbial reef regrowth in the narrows. We know that 80% of staph aureus infections can be tracked to the patient's own bacteria in their nose and that 30% of patients actually carry the staph aureus bacteria in their nasal passage. So this is kind of a hot topic now during covid the recent CDC guidelines for nasal decolonization that came out in 2019 strategies to prevent hospital onset staph aureus bloodstream infections in acute care facilities came up with a regimen of intra nasal antiseptic of either you Pearson twice daily to each narrate for the five days prior to the day of surgery or two applications of a nasal iota for of at least 5% to each. Narrate within two hours prior to surgery. Plus C. H. G. Wipes. This is part of a core strategy to help reduce the risk of sse for patients undergoing high risk surgery or high risk patients undergoing surgery or patients in the ICU. Also, I just wanted to note that A. O. R. N. Has updated their guidelines in 2021 to consume to include consideration of nasal decolonization for high risk surgical patients. The first study I'm going to start today was by Phillips in 2014 preventing surgical site infections. It was an investigator initiated RCT of nasal papyrus anointment and nasal pavilion iodine solution. It was at N. Y. U. Hospital who had a successful algorithm using new Pearson in their hospital. But they were looking for an alternative based on some concerns about resistance patient copay and just patient compliance. So it was really looking at patients who received the Pavilion iodine solution twice before surgery or the comparison five days prior to surgery twice a day. So it was really a head to head study over on the right we can look at the overall infection rate is just the cases for 100 subjects in the per protocol group. They saw a trend in the reduction of the overall infection rate for the patients who received the pavilion iodine solution. And then they saw a statistically significant reduction. Actually zero of s aureus infection rate for patients who received the nasal antiseptic with Covid own iodine. And they deemed that provide an iodine is a good substitute or alternative to mute Pearson in any program to reduce surgical site complications. The next study is by Bidco also in 2014, a really different situation. This was a v. A. Before and after study and they actually were specifically looking for a protocol to address their surgical site infection rate, prospective single study. The intervention group included stage 2% CHD clause paradox oral rinse and the three M. Skin and nasal covid an iodine solution. And the control group was of the year before implementation of 344 patients versus the intervention group of 365 patients. And there were, The results are on the right a 71% reduction in surgical site infection rate. They saw that COPD and duration of surgery were independent predictive factors of S. S. I. I don't think that's very surprising. But they also deemed that the decolonization protocol was an independent protective factor against surgical site infection, basically saying that the odds of getting a surgeon surgical site infection for patients who received the bundle the decontamination protocol are four times lower for patients than without the protocol. Then the third and final study I'm going to mention for this category came out in 2020 and Jama. This was the effect of improving basic preventative measures in the peri operative arena on staff or his transmission and S. S. S. It was a randomized clinical trial. I selected this one because it went across a range of different surgery types. They had planned 1000 patients but it was terminated early with only 236 patients. But they really looked at an I. P bundle that included process as well as product factors. So by process I mean hand hygiene, quarterly feedback. They did light therapy in the O. R. Reorganization of the anesthesia work area. And then they also looked at catheter and syringe tip disinfection and then decolonization with nasal papa and iodine. And the results are here on the right. I'm gonna point you over to the far right where you see the sec rate reduction Statistically significant of 7.7%. 20.9%. So basically 10 S. Is in the control versus one in the improvement bundle. Now obviously with any of these bundle studies and the research that we're doing currently you cannot always attribute the reduction of S. S. I. S. To anyone attribute. So my goal and the research is to really look at if we have an intervention that might include product multiple products and process changes really can we reduce the total cost to treat and improve on some of the quality measures such as surgical site complication and other complications. We were just looking at nasal anti sepsis. Now let's look briefly at other patient prep around skin after sepsis. Anti sepsis in anti microbial incised drapes. This is really looking at you know the bacterial load on the skin versus prior. When we were looking at the bacteria in the nose. Now the evidence is a bit conflicting and the guidelines are slightly different. But in general the guidelines indicate to use a dual skin agent preparation containing alcohol as one of the active agents unless obviously patient contraindications exist. So when you are selecting the antiseptic for your surgery, type in your overall SSD reduction program. Some of the considerations are obviously the patient factors I mentioned the allergies to age the skin condition. Obviously the location of the surgery and the breadth of the area that you want to cover with the antiseptic to address it. And the reason I'm bringing up your based antiseptic selection obviously um you're a prep and flora prep are very popular ones on the market. But when you're doing your skin prep selection, if you are going to use an inside group, you should know that the choice of your antiseptic prior to the drape can impact its ability to adhere to the patient some of them contain surfactants or attract moisture. So you want to make sure that if you're introducing one element into your quality improvement program that you're antiseptic selection does not interfere with that. So on the insides draping the C. D. C. Are the current guidelines now indicate that if you're going to use an inside drape, you should use an anti microbial inside straight in that situation. Eventually essentially it will help reduce cross contamination. And really what I would say is immobilized bacteria on the skin. And especially for surgeries where there might be a lot of activity or washing, you might want to end up to mobilize the bacteria that's deeper in the hair follicle with an anti microbial inside scrape. And if you include an anti microbial inside straight that includes um iodine for example, it will kill residual bacteria under the drape as well. So the first study is a comparison of both efficacy and cost of using the impregnated rape versus the standard rape in cardiac surgery. A study of over 5000 patients uh and they were actually propensity score match to make sure the patient cohorts were similar. So there were 808 patients in each arm. And they saw that the incidence of surgical site infection was higher for those patients received the non impregnated rape. And then looking at their own institutions actual costs, they actually noticed they were able to save money by using the iodine impregnated rape of about 707 \u20AC173 which is about the equivalent of 1000 U. S. Dollars. And essentially by the reduction in the surgical site infection rate. They use less health care resources further in the patient journey, there was a statistically significant reduction and negative pressure wound therapy for delayed wound healing. And there was also non statistically different decrease in sternal revisions for the control. So essentially what we're looking at is if you're going to introduce something in your quality improvement bundle, can you reduce the overall cost to your system? And that's what they demonstrated in their use of the iodine impregnated rape versus standard rape in their cardiac surgery population, these two are CTS are in the orthopedic area. They're not looking at surgical site infection. This is just looking at the contamination percent. They wanted to know. Just introducing the anti microbial drape. Make a difference versus no drape. So, can we decrease the bacterial load at different types in the surgery on the skin? And the study on the left with a large multi center RCT of primary knee patients of 1187 patients. And the use of ia donated drapes reduced the contamination From 10% to 15%. Statistically significant. And then on the right is a much smaller RCT. But it's for patients undergoing hip surgery where they saw at the end of surgery, 12% of incisions with the anti microbial drapes versus 27% without positive for bacterial colonization. So, essentially what they're looking at and what they're concluding is that introduction of the anti my pro build rape can help prevent that bacterial load or contamination during the course of surgery. So I'll now move over to patient warming, which I think is an area of people know much more in depth globally. I think the importance of maintaining normal serena is well documented and supported by local quality. Global quality guidelines. We all know that inadvertent peri operative hypothermia is associated with adverse outcomes such as cardiac events, blood loss, surgical site infection. I'll speak to one interesting study here and that we know that despite the global understanding and the use of new technologies around forced air warming, I ph is still an issue. And there was a study out of France showing that 53% of patients were still hypothermic ie bless below 36 degrees Celsius on admission to the pack, you and anecdotally. We're studying this more in other markets and saying that it still seems to be a problem. I will also notice that there are two recent systematic reviews and meta analyses on the effectiveness. Of course they're warming versus passive warming. I will discuss one of them briefly today, I think we all know there are really guidelines globally around the importance of maintaining normal hermia. This is a study I mentioned in 2011 CMS instituted guidelines for body temperature management protocol, basically a quality measure to ensure that patients undergoing surgery of more than 60 minutes, maintained norm Arthur Mia. And they basically measured compliance if they were above 36 degrees Celsius In the last 30 minutes prior to the end of anesthesia, the 1st 15 minutes after the termination of anesthesia. So basically they put a retrospective group at John Hopkins over four years of 45,000 patients non cardiac cardiac surgery patients. And they looked at those that were compliant with the quality measure versus those that were not. And what were the implications on some of the complications? And they saw a statistically significant reduction in hospital acquired infections, CV. Events, mortality and length of stay. So this is just a great refresher of why there is a quality measure why no Martha mia is importance and why it continues to be measured. And it's currently being collected in the ambulatory Surgery center in the U. S. So a recent R. C. T. This is the most recent study I looked at that was not a meta analysis looked at the value of pre pre warming with forced air warming prior to their normal warming protocol. So they looked at 212 patients undergoing primary knee and hip in one hospital in the Netherlands. And they looked in addition to their normal force their wording protocol during the operation if they added forced air warming for 30 minutes prior to that operative phase versus disposable warm blankets which were thermal insulation and warm cotton blankets and the rosa results you see on the right are looking over time patients receiving the active forced air warming pre the inter operative warming had statistically lower hypothermia rates at each step of the journey. And then on the far right you see a significantly lower complication rate within 30 days. The study didn't indicate what their complication rate definition was. We have reached out to the author for that but they did conclude that it might be a very cost effective and simple way to improve your normal thermal rates by introducing forced air warming actively prior to the operative face. I found two other pre warming studies that I thought were informative and helpful to think think through these are large. Real world evidence studies by one author retrospective analysis on the left looked at over 7700 patients across surgery types and essentially they looked at intra operative warming as I mentioned. Plus preheating in the anesthesia area versus patients who did not receive the preheating and the preheating is done by active forced a warming. And you see that the intra operative hypothermia rates and the postoperative hypothermia rates are statistically significantly lower for the patients who received that preheating or proactive pre warming prior to coming into the O. R. And then they actually did another retrospective study Their inter operative hypothermia rate was still at 15%. And they saw that an increase in their interruption time between the end of pre warming and the inter operative warming with forced air warming was associated with an increase in inter operative hypothermia. So essentially what this is telling us is that interruptions in forced air warming. If you're going to do pre warming as part of your protocol to help reduce the I. P. H. You want to make sure there's not too much of a gap because interruptions of the forced air warming of more than 20 minutes showed higher hypothermia rates than those without the interruption. So basically if you're going to bank heat by pre warming you don't want the gap in that process to be too long for it to be effective and impacting your hypothermia rates last but not least just quickly. Zeng's meta analysis of one of the ones I mentioned again they were looking at the effect of preoperative warming on the occurrence of surgical site infection systematic review. Where they were looking at R. C. T. S. Only prospective R. C. T. S. Only. They came up with seven studies And their conclusion was the use of preoperative active warming was associated with a significant reduction in surgical site infection. Use of active forced air warming was associated with a risk production of 32%. And I'll also note that a The use of forced air warming. Plus other measures such as liquid heating actually reduce the risk of surgical site infection by more than that by 48%. So an interesting paper to look at the impact of adding active forced air warming to your pre warming protocol. I'll now move over to our final category closed incision negative pressure wound therapy. Today I'm speaking about Christina therapy which is negative 125 mm of mercury. So the World Health Organization has global guidelines for the prevention of sSE they suggest prophylactic use of negative pressure wound therapy may be used taking resources into account on primarily closed surgical incisions in high risk wounds for the purpose of preventing essie's. And in addition I mentioned the U. S. FDA granted a change or a de novo indication in 2019 based on the evidence behind Trevena and their change includes its intended to aid in reducing the incidence of Ciroma and in patients at high risk for post operative infections. Aid in reducing the incidence of superficial surgical site infection with Class one and Class two wounds and Christina is the only medical device with this indication to aid in the reduction of the incidents of super full superficial surgical site infections. Again, to read the whole indications for use, please refer to our website but we are very proud of that. Very proud of. That was based on the evidence that we had in 2019 and since that time there have been more R. C. T. S. We're now up to 24 R. C. T. S. For this category. The first study I'm going to mention because it looked at their own economics within their institution on vascular groin surgeries. This was a Thomas, 119 high risk ephemeral incisions following elective vascular surgery. I'm actually going to attract your attention over to the right the high risk standard of care of 60 patients for the high risk patients. 59 that receives surgical incision negative pressure wound therapy. And we see a statistically significant reduction in these two columns for surgical site complications. Sse returned to O. R. And readmission. And they calculated within their institution. This resulted in a savings of 6000 and $45 per patient. So essentially by investing in the Praveen a therapy on their high risk surgery. Put patients in the vascular surgery arena, they were able to save $6,000 per patient by intervening with the right therapy. The next study is out of john Hopkins on high risk open pancreatic duodenal ectomy. I think the paper indicated about 30% of their patients were deemed high risk uh And that their historic rates of surgical site infection for this surgery type between 15 and 20%. Uh so they introduced surgical incision negative pressure wound therapy to high risk patients based on an externally published risk stratification protocol. And they saw a reduction of 68% in surgical site infection 9.7% versus standard of care at 31%. And that was at p .003. They also noted that the surgical site increase the cost 23% and the additional cost of complication due to exercise in their institution was close to $10,000. So they can easily do the math to see that the investment in a prophylactic use of in this case incision management can help offset the cost of complications at their institution. The next study I'm going to discuss is one that we're very proud of. That came out in 2020. It was funded by three M. R. K. C. I. It was a 15 center prospective RCT looking at Trevena versus anti microbial silver impregnated dressings for patients undergoing revision of total knee, arthur pless plasticky and all patients had at least one risk factor for postoperative complications. We did see the percent of subjects with surgical site complications statistically significantly lower Across all three time periods below. Also, a statistically significant reduction in 90 day readmissions and a statistically significant reduction in the length of stay for days if re admitted. And we are currently preparing a publication on the health economics of the results of this study. The next one is a meta analysis, uh which we were not a part of by Antonio, but it's an excellent paper for those of you in the vascular. It was looking at prophylactic negative pressure therapy for growing wounds in vascular surgery, Patients with Trevena therapy had a lower risk of developing s eyes by 79 and reduced length of hospital stay and a lower risk of revision revision surgery. I will say the vascular area is one of the highest areas of evidence for privy to. And they actually concluded that evidence can be considered conclusive and that no more trials are required in this patient population. So that's a very strong externally independent paper around the vascular. There's also a meta analysis that covers multiple surgery types. Uh And they do some deep dives in some subsequent publications on different subsets of the data. But across the R. C. T. S. And observational studies they saw that Trevena therapy significantly reduce the overall risk of S. S. S. Almost threefold compared with standard of care. I will note. I think 26 of the studies, there were 11 R. C. T. S. And 19 observational studies in this meta analysis. 26 included risk stratification for high risk patients. There is also an excellent risk stratification paper by anna tone. Were essentially this prospective non randomized study uh for primary joint. Our capacity patients, they had a history of using our blog across all of their patients, they instituted a risk stratification process. So any patient with a risk or over to using their own method received closed incision negative pressure therapy and the remainder received Xsl or term of on prem Eo and you can see on the right there historical high risk complication rates or patients with a high risk score of over two complication factors was 26% Before implementing the protocol with close incision negative pressure and 7.3% after. And overall the historical control rate of 12% versus uh post implementation of close decision negative pressure on the high risk patients got down to 6.8%. So basically risk stratification started to become a much more researched area uh as to who might be able to benefit from the use of ci Npt. And then one other paper around risk stratification, full disclosure. My team was involved in this study. This was retrospective out of Duke. They used to kill a health automated algorithm deep learning score that looked at over 70,000 patient records to come up with a tailored risk stratification algorithm for vascular surgery patients at this institution retrospectively, they looked at did the patients who were deemed high risk by the risk algorithm received ci Npt. And what was the surgical site infection rate for those who receive standard of care versus those who received the Praveen a therapy. And we saw that the actual sse rate for high risk patients was 6.8% for those who received Trevena versus 20.9% for standard of care. The study forecast of 41% surgical site infection reduction and a 26% cost production with appropriate use of Trevena. And interestingly to me, you see appear that Based on surgeon practice just looking retrospect retrospectively they used Trevena on low risk deemed patients 17% of the time or 31 patients. But they use standard of care on high risk patients 70% of the time. Which indicates there may be significant value in having a risk stratification algorithm for your surgery type at your institution. And they are now going to do a prospective study in the area of vascular with this risk stratification. So last but not least. I just like to mention that there's a lot of literature out there. We're happy to provide some really good independent risk stratification publications that talk about how you might want to risk stratify your patients based on general risk factors. The table on the list is out of weu's And nothing that's really surprising here. I'm sure. Bme over 40 uncontrolled insulin, diabetes, renal dialysis. All of the things that you think might impact or put a patient at higher risk for surgical site infection. They also had additional risk factors out of the same advisory panel by surgery type that might increase the risk of that patient. So it can help you determine what it's a good risk stratification algorithm to help determine when to use closed incision negative pressure as a recap We've covered quite a few categories today. Obviously in a very quick way the first was three M skin and nasal that has over 10 clinical studies. Seven peer reviewed and over 10 investigator initiated studies. I encourage you to reach out for more information from your representative on this product. The three endure a prop Combines two broad spectrum antimicrobial agents, alcohol which we discussed for the immediate anti microbial activity and then also an iodine provo selects for extended. And then we talked about three AM I. Oban antimicrobial insides drapes and how the inclusion of iodine in the actual drape adhesion helps reduce the bacterial load under the drape. Then we talked in the area forced air warming. Most of the research recently has been focused on the incremental benefits of adding active forced air warming pre you're warming in the O. R. And then the really the importance of what we're seeing still anecdotally beyond the study I mentioned in France is the importance of continuous temperature monitoring through the O. R. To help ensure that your ipod to your inadvertent peri operative hypothermia rates are in line with the quality guidelines. And then last but not least we covered three M'S. Praveen a therapy or incision management to help maintain the integrity of the incision for high risk surgical patients. So thank you for your time today and for the speed uh speed presentation