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Speaker: Speaking off this afternoon is a discussion on living skin equivalence in advanced wound care and we have asked Dr. James Stavosky to share his thoughts on this. His background is rather extensive in the area of wound care and podiatric medicine and surgery. He has served on multiple boards which are an important part of what happens in our profession from both the surgical side and the orthopedic side. So rather than bore you with a long list of accomplishment, I think most of you know Dr. Stavosky. So please welcome Dr. Stavosky.
James Stavosky: Thank you Howard. So it's actually been while since I've been at the treasure hunt. So Eric was, I think, the chairman at the time, so he reminded me of that because I'm old and I don't remember those things. So it's nice to be back and to come and talk. So I was given assignment to talk about how I used living skin equivalence in my practice and what I do. So those of you that kind of know or that are my FaceBook friends or whatever, I've taken on a new position that actually I started as of January. I'm the new Executive Director for the American Board of Podiatric Medicine. So actually, I've been in [indecipherable] [00:01:27] headquarters and I've been there for the last four days. We had a board meeting, so that was kind of nice but I'm still working. I work in the wound care center two days a week. And so the board allowed me to do that, so it's kind of my love and been passion for a long time. So hopefully, to give you a little bit of background on how I look at and what I do. I always let people know how did I start in wound care. Those of you who didn't know that I started my career in academic medicines. So I spent the first 15 years of my career teaching at the school in Northern California and I spent the last 20 years in private practice. So it kind of gives you range of what I've done. So I was in wound care as I always teasingly say before it was cool to be in wound care. 35 years ago, I was the only one in the college who would do it along with Steve Palladino and then Steve kind of went on to different direction and I kept doing it.
And I've been doing it for 35 plus years and enjoyed it. And it certainly changed in that time. Those of you who have been around for long enough, wound care is pretty much podiatry on the map, we were doing some great things before that, but it's really put us into the mainstream of medicine and hospital based programs. So it has really, really made a difference and it's kind of enhanced my practice to the point where someone says podiatry at medical center, they think of me and that's a good thing which then my associates all benefit from that, the other podiatrists in the area. So that's the way we look at it. So this is my disclosure. So you can see I'm on a couple of speakers' bureau, so I do speak for a few companies and talk but that's my only financial arrangement with them. The learning objectives, we want to talk about again how I use these in my practice and thinking about advanced wound care. I think we get stuck sometimes about what advanced wound care is and I will tell you in nutshell the way I think about it. If you are doing your normal things and everything is working, then you keep doing your normal things. The main thing we should look out with advanced wound care is for wounds that are healing on the normal process and when you've a larger wound that you need to heal faster. So when someone asked to define advanced wound care, that's what I talk about. So that's what I look at. I still do the simple things. I always start out with the simple things. If they work, fine, then I'm a success and we will talk about how I make the judgment to see if I'm a successful in doing that.
So that's kind of the key is I go through it. And I will talk about how I use the living skin equivalence. We were talking about this outside in the break and I realized that I have been using the living skin equivalence for over 20 years because I was fortunate enough to do one of the initial pilots on one of the skin equivalence and I did that over 20 years ago. So it's kind of fun to kind of look at that and think about that as we go through. So the skin equivalence that we are talking about the living ones are indicative for the diabetic foot and for venous leg ulceration. So VLUs and DFUs and we know it's a huge problem. The statistics change all the time but those two categories probably combined are the number one area of wounds that we see in the lower extremity. We certainly see a lot of other wounds but these are the mainstays of what we are dealing with and we are going to be talking about products that are used for this. If you look at the cost there, we are talking about billions of dollars spent on the diabetic foot in dealing with these patients. So if you can speed up the healing and get patients back to their normal life, obviously you've given them a better quality of life and you are going to get them back on to the mainstream as we go. You all know the statistics with diabetes, the rise of type 2 diabetes from teenagers is incredible. It is still a small number but that's happening and then people in their 30s to 50s we always thought of it as these are over 50s, it's not that way any longer. So it's changing and you've to realize that. So you are going to see this more and more and more as it goes along as we take care of this. And we know the problem. I mean we as podiatrists look at this and we see these problems in our practice everyday. These wounds become chronic. We know if we can get them in the acute phase, they are actually fairly easy to heal. The difficulty is when they are in that chronic phase of wound healing and we have difference. And if they fail conventional therapy and that's what I said, you always do the normal thing first.
You don't have to go -- and then people ask me, so are you using advanced wound therapy on every single patient that walks in? I don't. But I use my thought process and we have an algorithm that we use when we decide to go to advanced therapy. So I think you always have to do that. Most of us like to blame our patients on why they are not healing. You can do that but it's not necessarily the only reason. Sometimes, it's our lack of skill level and we are not doing the right things for our patients. So it's one of things we do. So how do you use these products? How do you make the decision? So you still have to do the good wound care. You've to take care of the infection. You have to debride and I know you've lectures on this already today, so I don't want to spend a lot of time. You have to make sure that you've a moist wound environment. You have to offload properly. If you don't do those four things, you will fail no matter what products you use. So that's one of the things that you have to think about. If you don't do good wound care, you are going to fail. And then you want to follow the standard of care and that's one of the things I will spend a little bit of time talking about is how I look at my standard of care and what I do to make that going on. Here is the Wikipedia definition of standard of care which means it's just a guideline that has scientific evidence behind it and there is a collaboration of medical professionals. So that's great. And those of us that have done things in the legal fields we know that we talk about this and I was up doing a program in Alaska a while back and I put a slide up there and I asked them. I said, so you in Alaska who practice in Alaska, is the standard of care different for you all from me who practices in San Francisco Bay area and he said yes absolutely. I said nope, not anymore. You can't claim that. With the internet nowadays, there is no difference in the standard of care and attorneys don't look it that way.
So the standard of care is standard of care. The evidence is out there. In the old days, you could claim, I didn't read that book or I didn't read that journal. Everything is online now. You can't do that any longer. You really don't have that. And what is evidence based medicine. So again evidence based medicine is things that people have studied and they can show evidence on how it works and hopefully, you are using that as you are selecting your products on what you use on your patients. It just shouldn't be because you like them. So when I look at evidence based medicine is I have a patient with a chronic wound that I can affect a change on that patient and get them to heal. Again, I've been talking about the standard of care. What is my standard of care? Well, there has been numerous articles. The first one came out in 2003 and we all give credit to Peter Chien for doing this in 2003. There have been other articles that have come out since. They talk about using evidence to support a standard of care. And what Peter did he was an endocrinologist and he looked at an old study, a randomized clinical trial and he looked at that study and what he showed is that he could do predictive healing rates in this. So that's what he kind of looked at and what he showed that if you didn't see 50% reduction in the wound after four weeks when you are doing all those four things right that we just talked about, you didn't see that, then you didn't have a very good chance of healing the wound. So actually in 91% chance of healing -- I mean negative predictive factor of 91%, only 9% those wounds would heal. So that was kind of the light dawned on a lot of us and we thought well, that's kind of interesting to look at that. And then I got to participate in the study, I think it was back in 2010, that we looked at the same type of information and we looked at that and we went through that and we looked at using wound closure in diabetic foot at four weeks and at 12 weeks and see how it was and if you look at this, you can see it's very informative on the predictive value of healing after four weeks.
In fact, our study showed that even after two weeks, it was helpful. If you look back at that slide, even two weeks, it kind of gave you a little bit of information about the ability. So if you didn't see some good healing going on at two weeks, it might not be the right way. You might be kind of looking at the different points. So we were able to show what Chien did, the 50% marker at four weeks was an important marker and so it really didn't make any difference on the wound size. So some people think that it's a difference, it really is not as you go through that. And I say this and this is little strong that that should no longer be the option, the 50% marker at four weeks. And what I mean by that and I will show you kind of what I do. This is my algorithm that we use and those of you that heard me talked before, I like to use this all the time. So if you are doing your standard of wound care and after four weeks, you haven't achieved 50% healing or have you? If you have, keep doing what you are doing. If you are not, you need to change. So I've gotten into arguments with the people, you know that doesn't mean you have to use advanced wound care. No, what I'm telling you, you habe have to change. And then people say, why? Because you can't keep having these people in your office for month after month, year after year, debriding them every week because something bad is going to happen. And when that thing that happens, that turns bad which means they have an amputation or they die, who they are going to come back and blame? It's going to be us. And people say, you know Stavosky can't say there is a new standard of care. So don't believe me. So if you want to take out your smartphones and look up footlaw.com.
This is a group of attorneys and board certified podiatric surgeons who are out there and they have it on their blog where they actually talk about that improper wound care is one of their areas of expertise and they would love to sue your physicians for you. And what they talk about, they actually use Peter Chien's article to talk about if after four weeks, your doctor has not done something different and you have a bad outcome, either you get an infection, you have an amputation or the patient dies. Call us, we will be happy to sue your doctor for you. So don't believe me. And I'm not trying to scare you -- I'm trying to scare you a little bit. But I'm not trying to scare you that you have to go out and use advanced products but you have to do something different. Okay? You have to reassess, take an x-ray, take a culture, biopsy the wound. I mean the horror stories that I hear about people telling me that well, I was treating the patient for a year and half and I finally biopsied and it's amelanotic melanoma. Oops, you think you are going to win that lawsuit. No. You are not. So these are things we have to be aware of. I know it's scary stuff. In my career and because I do mainly wound care, I've actually seen over 30 malignant degeneration in ulcers and I know that doesn't seem like a lot because I see a lot of wounds but when you think about, that should scare you that it's out there and if you don't look at it. We just had one last week, squamous cell. It looked weird and the resident was like, okay, we will just debride them. Well, before we debride it as this new patient who was sent to me from the podiatrist in the community, I said we are going to biopsy it. Okay. So we just did a little quick shave. It wasn't a big thing. So we just took that piece, sent it off, squamous cell. Alright. This happen. You have to be aware they are out there. If it looks strange, biopsy it. So our kind of rule of thumb if it's been there for longer than four weeks and you are dealing with it or if it comes to you and it's a chronic wound, you biopsy it.
You culture and you biopsy it. So one reason I get in argument about this all the time with culturing because I truly believe and we talked about infection, culturing is an important component of understanding there is bacteria, has a bioburden that's slowing down the healing process of your wound. It is not infected and I agree with Warren, it is not infected wound, but I'm doing it a different way. That doesn't mean you put every patient on antibiotics. It just means you need to know what's going on that wound. Now, there might be a choice that you decide you are going to take care of that bacteria topically using something that you are comfortable with, that's fine but you have to do something. So the main thing that I want you to remember you have to change. One of the problems that we have in our profession or going to a different podiatrist or to different wound care center, they go to 13 and they get 13 different things done to them. I mean this is what happens. So when we talk about advanced technology as we go through things, again we are going to look at cost. Does the benefit outweigh the cost? And that's the way I always look at it. So if I can decrease the healing rate by 30% to 50% by using expensive device or product, it's worthwhile. It really is. So if I can take three to four months off their healing time, then that's great. So that's we are going to do -- ease of use to make sure there is available science behind it. So there are different types of products out there that you should be aware. There is PMAs which are premarket approvals. There are 510Ks which is kind of everything else out there and then there is human product, human-derived products. So those are the products that are out there that are classified. The PMAs are the products that have done their standardized studies beforehand. They are randomized clinical trials before they came to market. That's why they are called PMAs. And of all the products out there and hopefully every one could answer this, how many are there, I just showed you the picture, there are three. There are three that have done that.
That doesn't mean that the other products are not good because they did their studies afterwards. That's just what happened. That's just the process that went through. So that's just kind of understanding the difference. The three that I'm going to talk about other than the [indecipherable] [00:16:11] gel is the two products that I want to talk about today. So then everything else is 510Ks and I use a lot of 510Ks and I use a lot of the HCTs also. And that's okay. You can use other products out there and it's fine. You just have to kind of know what you are looking at and why you are using them. What is the advantage of one over the other? So one of the things that we look at is when we talk about evidence based medicine, you've all seen this pyramid at some point in time and thought about it, the different levels that you look at in terms of evidence. Now, you like to see everything having a level 1 evidence. Well, where am I at? I'm down level 5. I'm talking to you as an expert supposedly, so I'm level 5. I'm like the lowest. So you have to look at the studies and you should be able to see that and see the data. So when you see what goes on, now we are fairly fortunate state of California because our Medicare subsidiary requires a product who have randomized clinical trial before they will pay for it. That's in the state of California. Not all states do that way. So we are little bit fortunate in that, so our products are good. But they only might have one and if you look at the trial might not be such a great trial but those are the things that are there. So you kind of have to look at the products and they are not all the same, so you kind of have to decide what you want to use. What features does that product have to use and sometimes it's ease of use. If you are doing this in your office, sometimes having a product that's on the shelf for you is a better choice that you have right there. Sometimes it's product that you might have to have a freezer for. You have to make that decision. I will give you my opinions on what we do but those are things that you have to decide that you want to do as we go through it and they are classified in different ways. For covering wounds, for managed wounds or actually treating the PMAs, so the only one that have an indication that can actually treat the wound because they did the PMA beforehand.
So the other ones are just managed or cover wounds and that's okay. So these are kind of the products that are out there in the classification there in as we go through this. You just have to think about what's going on. How long will these wounds take to heal? So you have to be honest with yourself. David Margolis did a study long time ago and he looked at VLUs and DFUs in randomized clinical trials to see how quickly wounds healed and you can see for DFUs, it's 12 weeks, 24% healed; at 20 weeks, 31% healed in the study he looked at. For venous leg ulceration, only 44% of the wounds healed in 24 weeks in the trials that he looked at. That's a long time. So I was telling our patients, oh yeah, it will be healed in a month or two. It doesn't happen, really doesn't happen. So and if you are honest with you and you keep track of these things, you really kind of notice this. So again, we look at this prediction using that 50% in four weeks. In VLUs, you can actually use 40% before it because they don't heal quite as fast but again you want to think about that and use that as you are making your decisions. So use that four weeks and then make a change. I'm not saying that you have to go out and use different products. Use what you feel comfortable with but you can't keep doing the same thing over and over and over again. And I wear multiple hats in our profession. I happen to be a consultant for one of our malpractice companies out there and I can't tell you how many wounds I see over and over again. Now, I will tell you the podiatrist probably hasn't seen the patient for six months, but the person to get sued is that podiatrist who was doing the same thing for a year and the patient has an adverse event, ends up in the ED and someone cut their leg off. And they want to blame somebody because the diabetic is not their fault. I mean their sugars are 700 but it's not their fault and they are infected and pus is flowing out of wound.
But it's not their fault. It's the podiatrist who saw him six months before. This is what we deal with. This is reality. So let's talk about -- there is multiple products that you can look at and we are going to talk about a bilaminar product that's basically dermis and epidermis and then we also talk about dermal-derived products. Those are the two we are going to talk about. That just went away, how did that happen? Oh, there it is. So we are going to talk about this one first. And because this is CME, I try to use the generic term for it. So if you don't know what it is, look it up on your phone. But that's okay. I will probably slip and use the term. These are the indications. So whenever you are using the product, you should always look at the indications for your product and know what it's approved for. Now, I will tell you the products that are PMAs have much stricter indication of use. So if you look at the two living products, these two products, they are very restricted. This one, the D product which I'm not going to say but this product is used for diabetic foot only. That its only indication. It's contraindication as you can see is that if there is clinical infection, sinus tract or if you are allergic to some other products, but it's the wound that's been there for at least six weeks or longer. There is no tendon, muscle, joint or bone involved. They are not approved to put over those and it's a full thickness wound that's been there for six weeks long and that's the indication. This is what it is. You know it's on the Vicryl suture mesh and they have living fibroblasts that live on it. This is kind of what the suture looks like which degradates because we know that it's degradated by hydrolysis, so the fluid in the water in our body. That's why we keep them wet for the whole time and so we have living fibroblast on this product itself.
If you've never gotten the opportunity, it's great, they make it down in La Jolla, California and I have been to the plant there where they actually make it and the bio-generators they use to do this is pretty cool, high tech stuff on how they put this together and what they go through with it. So they are able to test it and see what's going on. It is a frozen product. This is their phase three trial that they did, their third pivotal phase. This is one that I got to participate in. And you can see compared to conventional therapy, it had 64% relative healing rate compared to conventional therapy. That's not bad. That's pretty good compared to what you consider and remember these studies were done in the late 90s, so we kind of think of standard of care then versus now is a little different. Our offloading was nothing [indecipherable] [00:22:52] shoe with the hole punched out of the sole. That was what the offloading was, not what we use nowadays but just so you kind of know how this one was set up. I always think it's funny when you look at the safety protocol or adverse effects. The patients who are in the study that got the product had higher incidents of flu-like symptoms. Obviously, this product didn't create flu but that's what the people reported as they went through that. So that was kind of interesting to see. So the other product that we have which is the bilaminar product as we go through, so they have the same thing and you look at their indications. They have VLU and DFU as its indication as we go through this. And you can see four weeks for venous leg ulceration and three weeks for diabetic foot ulceration. Same kind of contraindications and infection, allergic to anything bovine because the collagen they used to grow this product actually has bovine collagen in it. And again these are the clinical trials. I did not participate in this trial. It was done at CCPM in northern California, part of it was, so I did get to see it in play.
And again, you can see healed wounds faster. That's what these advanced products do. They healed wound faster and got wounds to faster closure rates. They also showed in their study they had lower incidents of amputations and osteomyelititis and they are treating for up to six months after they treated these patients using this. And that's mainly a source of healing the wounds faster as we go through. Here is the adverse reactions for the DFUs. You can see almost the same as the controlled. So that's the DFU ones. This is the VLU trial. This is the one that we did at CSPM and the interesting thing about this is you have looked at the suspected wound infection was much higher in the product use. And the reason for that is we had no idea in the late 90s what this product look like when they came back after weeks. So lot of this we are reporting this thing as infected because they look slimy. The product kind of looked like slimy on there and that must be infected. So we marked that. So that's as you saw. If you looked at the other trial in looking at it when they did it for diabetic foot, they had lot less of that because by that time the people that were doing the studies knew what they would look like after they came back. So I thought that was interesting to look at that. So I don't think it's really phenomena. So for VLUs, it healed them three times faster, almost four times faster for DFUs comparatively. Now, these products have been around for almost 20 years. So they also have data from over 2000 wound care centers and many physicians that have used this product and they have collected this data and they collected this data from 2009 to 2012. So a three-year period of time. So now we are going to look at how this data actually look when you are comparing real use of it. Some of you might have been involved. Some of your data might have done, this is Health Net data. So if you are expert in your wound care center, your data might have been collected in this study.
And basically what it showed for DFUs that these products healed wound faster, compared to a [indecipherable] [00:26:11] which was kind of this standard at that time and so that was pretty remarkable, at a fairly high rate, healing wounds faster in the real world. Again, these are real patients. These are not in a randomized clinical trial. These are us that are actually treating these wounds. So healed wounds faster. They did the same thing for using the other product in venous wounds. So it's the same thing, same product. 1000 wound care centers over 20,000 physicians participated because that's what they did and again here is the number of patients they did, so huge study not a couple of hundred people. And here it is and here are the percentages as we go. So again, healing wounds faster. That's what these products do. And that's what we try to do. That's kind of the summary of that. So you're comparing what they did in the randomized clinical trial to what we did in real life from 2009 to 2012 and it's kind of remarkable to see how well they did. They actually did better in real life use than they did in the randomized clinical trial. And if any of you ever participated, you kind of know why because you are so restricted in what you use and what happen and like I said the offloading wasn't very good. So I'm just going to finish up showing a couple of cases, so you can see again how I've used the products as we go through. This was using the patient and again oops, this one slipped through. I'm supposed to take those names off of there. But this is using the fibroblast product as we go through. So this is one of the first cases that I did. This is actually during the clinical trial that I did. This is my kind of aha moment and I'm like wow. I've been treating this guy for a long time almost two months and getting nowhere on him.
And so then we used the product and I had a very successful healing on this. This was the first patient in California that was done in a private practice and that's why I did him in my private practice. The box was cool. The dry ice was probably the best thing about the whole thing. And those of you that I have rotated through my office know I would be playing with the dry ice and the students and residents would be seeing the patients, taking care of them and I would be playing with the dry ice, but that's just me. So I have a bad reputation I think in this, but anyways so this is using the product. We usually use a silicone based product to cover the wounds because we wanted to keep that graft moist for at least a week and we leave it in place for a week. So whatever silicone based product you like, do that. I don't like petroleum based products. It's not my favorite. I like the silicone based products. They are little more expensive but I think they do a good job with it. Mepitel was the first one out and then we used -- you can use Adaptic Touch and what we use is Versatel. It's a Medline product. It's the third of the price of the other ones. So when I'm paying for it, I get the cheaper ones, especially if it works just as well. So this is what I do. And then just showing then going on offloading and I'm using total contact cast, getting them to heal. Venous wounds using the bilaminar bilayer product. Another venous traumatic wound using that product. Diabetic wound using the bilaminar product with a big necrotic wound on top that we debrided. This patient we started with negative pressure first and then went on to use the living skin product. And then I will finish up with the last two cases. I always like showing, these are my favorites. Anyone who has seen this, they've probably seen before. Some of the student doctors out there that are out in private practice for 10 years probably remember these patients.
So this is kind of team approach. This woman came in, we saw her in the ED. You know, these you can smell on, they usually get these on Friday afternoon. They call you, they've been there in the ED for two days and you are like -- and you waited this or you know they've been there for eight hours and they finally call you in the 5:00 o'clock. And you take x-ray and you see those gas and so you know you are not going home. You know you are going to go to the OR and you clean that up. And so we did it. My philosophy, you know, you don't have to be in rush to take anything off. I will tell you my resident who will go unnamed, she kept harping in my ear, just cut the toe off, just cut the toe off because she knows she is going to have to use the negative pressure on this and will have to change the dressing, just cut the toe off and then we can close it. Just cut the toe off and we can close it. I didn't anyway. So we go on to negative pressure. Where am I pointing because it doesn't like me. This is good granulation tissue. We went on to use the skin equivalence. It smelled a lot. So we would stop, we go to a silver product. We kept changing. There was smell. We re-cultured it. But it kept getting smaller and smaller and smaller. So then the light dawned on us. I'm Polish. The light has to dawn on me and we went on, we healed her. And once the light dawned on us, some of you know this thing that her brother who is retired pharmacist who brought her in everyday on that light when that came in, he said, Dr. Stavosky, you did such a great job on my sister, would you care to look at my wound? You have a wound? Oh yes, he did. So the smell that I thought this poor woman was, it was her brother sitting next to her with his venous leg ulceration that he had for 19 years. So anyway, we cleaned it up. We debrided it and that's the bad one. We used compression therapy, multiple layers. We started with silver alginate. We did it, we got it down to this. This point of time, then we switched over to the bilaminar product. We used multiple pieces. We got him to heal and we had success. So again, they will speed up your healing process. Don't forget what you do. After weeks if it's not 50% better, change. Do something different. Heal the wound as quickly as possible. This is what we were trying to prevent. Thank you very much.
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