Section: CME Category: Surgery Wound Care

Utilizing Amniotic Tissue in Limb Salvage

James Stavosky, DPM

James Stavosky, DPM discusses the use of amniotic tissue in surgical cases such as 1st MPJ arthritis, nerve and tendon injuries, and surgical wound closure cases.

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Goals and Objectives
  1. Explain use of amniotic tissue in surgical cases
  2. Examine the use of amniotic tissue in 1st MPJ DJD cases
  3. Examine the use of amniotic tissue in nerve and tendon injuries
  4. Examine the use of amniotic tissue in surgical wound closure
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  • CPME (Credits: 0.75)

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    Release Date: 12/13/2018 Expiration Date: 12/31/2020

  • Author
  • James Stavosky, DPM

    Dept of Podiatric Surgery and Medicine
    Seton Medical Center
    Medical Director
    Seton Center of Advanced Wound Care
    Daly City, CA

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  • Lecture Transcript
  • TAPE STARTS – [00:00]

    Speaker: Our next speaker, James Stavosky. Pleasure to welcome you to the podium. James has had key academic positions at California College of Podiatric Medicine. He has been very, very active nationally and has had over 30 years of experience in wound care. He is going to help us put into perspective the role of the dHACM.

    James Stavosky: Good morning. So I'm going to take one small piece and I think it was important hearing before that you have to get your patients ready before you think about doing wound care. You can't just do wound care. You can't just use an amniotic product. You have to think about the whole patient. And diabetes is such a difficult disease that we deal with our patients because so many of them are in denial and the A1c and glucose before we take them in to surgery even when we were treating them at wound care center or in your office, it's so important to understand the disease state that kind of got them in this position. So it's a unique process. I don't like to share too much because I need to get into my topic but it's kind of dear to my heart because over a year and half ago, I found out that I was diabetic and I decided to take control of it and so some of you that know me or don't know me, Bob knows this. I lost 70 pounds. I work out every day. My glycosylated hemoglobin was 10.3 and now it's 5. So I call BS on my patients all the time. Yes, you can do it. You can do it. Is it hard? Absolutely, it's hard. Did my whole family participate? Absolutely.

    But you can do it. So this whole thing, it's such an important component of that disease process. Sorry, let me get back to what I was supposed to talk about. But it's so dear to my heart because as someone who has been in wound care for 30 plus years and you are like oh my god, I'm diabetic. Oh my god, what did you do Jim? What were you thinking? So anyways, something to do -- but now your endocrinologist all want to talk to all the patients. You did it. Now, they can do it. Well, it's tougher and it was easier for me. I'm not neuropathic. I don't have some of those other issues, so it was a little easier for me. So I'm going to take one little small area and talk about amniotic products in there. It's a very confusing thing. So this is just my disclosure. So I'm on speakers' bureau of these companies just so you understand that. Try to go through a little bit on how I use an amniotic product and I'm going to specifically talk about dHACM which is one specific one because when we have wounds like this and we figure out, well, everything that we are doing normal wound care is not working for them, so what else do I need to do? So it's just one other thing in your bag that you might use. I'm not saying it's the only thing but it's an important component to think about when you have a patient like that. So that's a heel wound and you will see this patient later, we go over this. So as you look at there, there are so many products. There is 20 plus amniotic products out there exhibiting. I put little red marks of the ones I have used just because when you are in the space, you have try things. You have to use different things and find what works best for you. You can't just grab and I always tease because I have students and residents to rotate through with me and it seems to be the way they determine what type of products they are going to use is whoever bought them their last meal, who gave them their free meal. Let's all use X because X paid for our dinner last night.

    Not the best way to do wound care. So we are going to think differently. So you have other ones, viable human cells, other viable human cells. Human cells that are non-cultured and intact. And again, all the red marks are the one I have tried. You can't try them all. So you have to pick and choose what works well. How do we determine that? We try to determine what kind of science is behind it, what kind of relationship you have the rep. Is it a reputable company? Those are all the things you make that decision as you go through with things. And what is amniotic tissue? Why do we use it? Well, it has been around for a long time. Kind of the key factors that I look at is decreases inflammation, decreases scarring. So if we have something like that, that helps us, that decreases scarring, decreases inflammation. We know wounds get stuck in the inflammatory phase of wound healing. So if we can get them out of that or help guide them out of that, those are all good things. These come from scheduled c-sections. That's how most of these products are harvested and then they are then processed by whichever company is doing that. If you want an amniotic product, you can just contact the tissue bank and you can have your own company if you want. It's not that difficult. Just be careful because one of the buzz words that goes around and when you do this. Supposedly, there is over 90 amniotic products out there right now, and what they all do, they come into our wound care center and they say we have a cue code, famous last words, but can you get reimbursed by my MAC? Can you get reimbursed by the company that's taking care of my Medicare? And lot of them can't answer that question because they have no idea of what they are talking about. So those are the things because for mine and I happened to have Noridian for me is if you haven't done the randomized clinical trials, Noridian is not going to pay for it. So it's as simple as that. So these are things that somebody's companies don't know. Where is the amniotic tissue come from? It's the lining of the amniotic sac. That's what we are talking about. We are not talking about cord. We are not talking about placental. We are talking about the lining of the amniotic sac.

    That's what this product is. That's what dHACM is. There is lots of choices out there. Again, how do you choose? It's a tough decision. It shouldn't be who bought you pizza or who bought you steak dinner. Really it shouldn't be. So you want to look to make sure what's the difference. They are not all alike. Some of them are combination. Some of them have chorion and amnion. Some of them are only amnion. Some of them are only chorion. So when I make a choice and looking at that, I want to decide. Well, I like dHACM only because it has both in there. And I think there is benefits of having both which we will talk a little about. It's little more of a robust product. It's little thicker. So it's not quite as thin and you have to try this. Again, things are going to work different in your hands than they work in my hands. So I'm just giving you my perspective on how I do things. I liked it because most of these things have cytokines and proteins in them and growth factors that help stimulate the wounds. And what we want is decreased inflammation and we want to get the wound care, the wound healing up and running. We want granulation tissue. That's what we are trying to achieve. So we want things that will create neovascularization of the collagen, fibers to be laid down by the fibroblast to fill in that wound. That's what we are trying to achieve. So if you have products that can help you with that, that's what we are doing. And what they've shown is that when you do a combination of the product, usually the amnion affects one source, it's about 20% of what you need and the chorion is 80%. And then if you look at this, you can see the amnion which is the darker blue and you can see it's epidermal growth factor. It does better for the "skin" because it has more of that product in it and the chorion does more for growing the granulation tissue, just kind of a rough idea as you think about as you go through. The other thing I like when you look at science of different products is I want a product that's not just one and done. I like a product that continually can put growth factors in.


    And I actually heard a talk by one of the scientists for this company and what she talked about is that when you first hydrate it, you get that first dump of protein and the cytokines and the growth factors into the wound and then it continues to release it, that's pretty cool stuff. To be able to have that. So if amniotic products can help us with that, that really gives something going on. The nice thing is that the amnion and chorion have a little bit of synergistic effect that having them both together gives you even more of the stimulation of the fibroblast which is good because fibroblast-collagen-matrix that's what we are looking at from there. Angiogenic properties the same way. We need fibroblast. We need a new blood vessel growing so we can do it. Stem cell is kind of buzz word going on now. Every dry things and we know everyone if you wound yourself, you need your stem cells to go in there to help heal the wound. We know that's going on. They did a nice little clinical trial using a fluorescent mouse. They hooked it to a nonfluorescent mouse and what they did is wounded that mouse, the normal mouse and they looked to see where the stem cells went. And they saw with dHACM, more stem cells went there. All these mice were retired living Palermo, California and none of them died. Don't throw blood on me. I had nothing to do with the study but just so you know. I'm just teasing actually. But this is what we have to do. We have to see animal models. This is how we learned about wounds as we go through. So what do they do? What does dHACM do? It's going to stimulate your wound and your stem cells to do different things, the fibroblast, endothelial cells and we talk about hemopoietic stem cells and then the bone marrow stem cells and also adipose. Adipose is kind of important because those stem cells we see are issues in diabetics. So that's important to be able to look at that and see those things go on and then we get out cellular migration and proliferation and the biosynthesis going on. Wounds healed. That's what we are looking for. There are studies out there. Look at the studies, they are fine. Read studies for what they are. We all look at studies. They are interesting. This is how they get recognized by different things to get reimbursed.


    It's fine but take them with the grain of salt. I mean if you delve into studies, you will see some are good, some are bad. Usually, they start out with bad ones and they get better ones as they go along as they get more data and more patients going along with that. So they have them both for the diabetic foot and venous for dHACM. So they are available and if you want to see them, you get them but let's talk about patients and let's talk about how we use them. So again this has been a product around for long time. They've been using it in eye surgery and oral surgery for long times. They've been using amniotic tissues, and in surgery or wound care, we decrease inflammation and scar tissue, that sort of thing. So there is lot of uses either in your office or in the OR. I want to talk about limb salvage because that's what we are talking about, limb salvage. This is my first case and this was a neuropathic patient who was not diabetic. So my kind of go-to living skin equivalence of the time were not available to me. I couldn't use them. I couldn't get them approved for this patient. So I used dHACM and I was happy with the success of that. Because one of the issues that you've seen in using some other products, it was easy to use. It's the product that's on the shelf, so I could do it once I got it approved and prior authorized, I could use the product on the shelf. So that made it easier for my life. So this is a patient and we all have this in our practice. They come in and you are like, what did you do? The patient -- what do you mean what I do? Where did you get this? And you can always see if you look at the stickers which I guess I'm supposed to block out but the stickers because you can't know anything for this unless you knew her medical records number and you knew what hospital I practice at. You could look it up but other than that if you look at it, wound number is 10. So that means she is one of my players. This is not the first time that she has seen me. This is her 10th wound. So you look at this and you are like. This is not a normal neuropathic wound. And so you are looking at -- okay, so we recognize it, this is a thermal burn. I live in Northern California. We don't deal too much with thermal injuries.


    This is not something -- I don't see much frost bite and it doesn't get that hot there. We are not in Arizona. You recognized this and I know that I've learned on listening to other people to deal with thermal burn is you wait. You see what happens. You don't have to rush in to the OR and see what's going on. So we waited. She cooked her foot. She cooked her whole heel. To this day, she won't tell me what she did but she did something. Where there was a space here, whatever she did, but it cooked it pretty well and it was just getting worse. So that's where we kind of start with the first patient. So now I'm at this point. The heel looks better but it doesn't look good. It's down to bone. There is tendon exposed, so we are going to take it to the OR and we are going to use dHACM on it in the OR. And we use it under negative wound pressure. That was one of my thoughts it's a deep wound, so if I can use the combination therapy, I thought this would be good. Now when I use negative wound pressure therapy on it, I actually leave it on for a week and I got this from Lee Rogers and David Pugach. They are the ones who kind of first did this and so I kind of took their lead and I tried it. So I left it on for a whole week. I put the foam directly over the product and when it came back, it was a little slimy. So when I go back and I reassessed what I did, I probably should have fenestrated to let a little drainage come out through the negative pressure, that would have been the better idea. So then I get a call from one of the vice presidents of the company who said, Jim we have this new product. We have a different product and it's actually a mesh. And I always put it and I was the first in California because I got to use them before David and Lee got, so I just kind of like that. Not that there is any competition among us out there doing things, but so I used this product first in California. So this was a great product to use with negative product therapy. So you are going to see what goes on. Think about the plantar fascia, those of you are looking at sort of toes are up here.

    And remember the plantar fascia because she cooked her whole heel and what's going to happen is we are going to go along and we are going to get some good results and then you are going to see there is a little issue and we will talk about that. So we are going through, moisten it, debride it. Look at the granulation tissue, pretty nice looking granulation tissue. What's causing it, I don't really care. Is it the negative pressure? Is it the dHACM? I think it's the combination of both. And at the certain point in time, I want to stop the negative pressure. We are filling in pretty well. Negative pressure has probably done its job. It has filled in pretty nicely in doing this but look at that little area, that little tunnel area. So we had to stop everything, clean that up, clean that little plantar fascia that died and we went back on, getting smaller. So that's what we started with. Now healed. Yeah, Jim, you are so good, pat myself on the back. But what happens, the patient decides to go celebrate and go camping right after she got healed. Yes, she did and she came back a week later with that and like wait. If you see the wound, it's over there, that's a new one. Thank you very much. So same process. Because this is fairly superficial wound, we didn't use negative pressure and got it healed. Yeah. No good deed goes unpunished. This is the other side of that same heel. So whatever she burned herself with the first time, she did it again. We should learn but I'm a victim of this, so again it's a burn, you wait and you see. She cooked her whole foot, we opened it up, we cleaned it out, we started again. Just go through the same process, went in and out, cut it out. I don't know who came up with that. It wasn't me but we just go through the same process and then hopefully, we get her healed. This was another patient and I still see her.


    She currently has no ulcers. So I see her in my private practice just for maintenance and getting her shoes and cutting her nails and doing that like we do with diabetics. This is another one. A smoker. I have no idea what this was. He said he had an injury to his foot. It had pseudomonas in it. It was nasty. We used silver alginate to start because I start with regular wound care. I don't jump to the skin equivalence or anything like that to begin with. We do good wound care. If I can heal it, well with that, that's what I'm going to do. Keep it reasonable, keep the cost down as we go through but it wasn't getting any better. It got worse. Actually then the pseudomonas got resistant to oral medications because I think wounds most of them are colonized and I think you need to go in there and clean them up and do that. I know Warren Joseph will take exception to that with me that if you don't see surrounding erythema that you shouldn't be treating it or culturing it. I find there is enough bacteria that I think I need to treat it. Most of these wounds that come to us in wound care centers average about 8 months. So they already have the wounds for eight months. So that means people have been trying before I get to them. So I like to kind of explore everything. He talked about assessment. I like to assess the wound. I want to know what's going on. So that's what we did. So now you can see the toes dropping down because the extensor tendon is gone and that's the proximal phalanx sticking out of the wound. So now, I'm going to take it to the OR. I'm going to clean it up. Yes, I put a pin in there in open wound because the toe was just like hanging. And most people said, Jim, why don't you cut off the toe? I get this all the time. I like toes, one tenth of my business. I don't like cutting toes off. It's just not me. So go ahead and did it. We went back to dHACM on this and got him to heal. So good results. Again, we always like to show the good things. Here is another one. So another patient with vascular disease. We re-vascularized them. And we know my vascular surgeon, he does [indecipherable] [00:17:53] for me, gets it going, take it to the OR, we clean it up. We decided to use the same thing, we debrided down to bone.

    We are going to use the negative pressure on them along with dHACM to do that. There we go. What happened? He didn't come in for two months. Two months, he didn't come in. He had a VAC on. Where did he go? He went out of the country. That's what he came back. Two months later, he comes back. Are you kidding me? Am I good or am I good? It's like pretty impressive stuff. So we have to start again. He has to be looked at again by the vascular surgeon. He blocked off after two months because he spent 18 hours on an airplane flying to a different country with his VAC on. I don't know how he got through security. Don't ask me these questions. I don't know, so. It never returned from that other country. So I don't know. Maybe he paid for his trip by selling that unit there, but anyway so we started again. Here we go, same process. Now, if you go back one, you can actually see the Achilles tendon poking out of the bottom of the wound. Did Jim cut the Achilles tendon off and detach from the bone?

    Yeah, because I'm worried to getting rid of infected necrotic tissue. I can worry about function later. So this is just the same process, getting smaller, smaller, smaller. From that to that. Okay. So we can do good wound care. This is one of my favorite. This is the patient if you count and we are talking to mostly podiatrist here but not everyone and so I always like to tease people, one, two, three, four, toes, something happened. Someone did an elective surgery on this patient, her second toe got amputated because something went bad and she had wound dehiscence of the amputation present. So as you go through this, she was actually sent by one of my ex-residents who used different grafts on it and said, Jim, it's not working, what can I do? I'm like okay, I'm the wound care guy, 30 years of experience. I'm so impressive. So I go and like three weeks, nothing is happening. I don't get anywhere. So then one time, I walked in just to say hello before the nurses took the dressing down and things like that. We don't have white Coban.

    Where did you get white Coban from. Oh, well, my wound was kind of itching and so I was scratching it and did it and we were using grafts on the time, we were happen to be using dHACM on it. And I'm like you did what? And you changed dress because we leave it on for week. They are not supposed to touch it. Nope. So what we found out is she was messing with the wound. She had a little Munchausen going on. She liked to mess with it. It itched, it scratched. Who knows how long the grafts did, so we were wasting your time. So what we decided to do is even though she is not neuropathic, we decided to cast her. We do lot of casting. We are going to put cast on it. Sorry, you can't touch it. You are done. So then once we started doing that, we got it to heal. To the point when she is healed for the next three months, I casted her till she got some counseling, some psychological counseling because she knew she had a problem with this because she told me, look, if you let me at it, I will open it back up, she was honest. So these are patients we have to deal with. This is kind of one of my fun ones. This was a Sunday afternoon. I always like to say Friday afternoon because this is actually Sunday because the patient had already got admitted on Friday and if you look there are sutures there because another doctor and we won't talk about what specialty had already taken the patient to the OR and done the I&D and taken care of. Great, thank you. But then why I'm getting called on Sunday afternoon which I don't like any call on Sunday afternoon most of the time. It's not fun. So what's going on? If you look at the bottom of that foot, you can see one, two, three, four. So the other doc amputated the fifth ray. Great. And he closed it. Okay. Not a prob. Maybe a problem. Maybe he should look at the CT scan that showed all the gas in the plantar aspect of the foot that they did on the day patient was admitted. But that's okay. The little arrow sign on that and I love -- when you get things from radiology, it's always great to put arrow sign like and I actually called them on this. Okay, you put the arrow sign on the first metatarsal, you are concerned that there might be ostia there. Thank you very much. That was very helpful. All that black stuff, did you think what that was? And they are like, what, it's just air. I was like air or gas? Oh my god, that's gas and they re-wrote the report. I'm like, Dude, what are you thinking about? It's like -- it's gas. So I mean that's what closed.

    This is actually after the resident pulled the suture out. They closed that black stuff. They closed that with pus still inside the foot. And I will tell you on this case is as we got in there. So went in out, cut it out. You need to open it up. My resident at this point, so this is what it looks like nasty. You can see the plantar aspect. You know you are going to be in there while. You are going to be [indecipherable] [00:22:38] this foot open. And what do you do? You keep going till it's all out. Why? Because now this is not limb salvage. This is saving their life. They are going to go septic and dying and we all see this. We have all had patients that have gotten so sick that they actually died. This guy is in his 40s. So we need to go in. This is the picture that my resident literally said to me, Dr. Stavosky, don't you think we ought to stop? Did you just stay stop? So the idea is to get all the pus out. I'm not worrying about wound care or limb salvage. I just want to get all the infection out because this man will die if we don't take care of it. You know his glucoses were in the 800s and you are arguing with anesthesia. Well, maybe we need to get the blood sugars down like you had two days to do that. The reason his blood sugars that way is because he is full of pus. His leg is full of pus. So we cleaned it up and I will tell you in retrospect if you have the conversation. Limb salvage or so you've the conversation with the patient. Okay. I will try to heal it but it's going to take six months to a year. Best case scenario. Six months to year. This foot. Six months to a year. So we tried some other products. We started with negative pressure. We used dHACM fill. Thank you. I have to be careful of what I say, don't say product names. So this is what it is. You can see good granulation tissue up to this point, we are just using negative wound pressure. Believe it or not, that black stuff on the top of the foot. When I poked at it, it bled.

    So Jim is thinking, okay, I'm going to leave it there as long as I can, maybe it will revive. It didn't. Okay. I'm a Polish podiatrist. I just don't always -- but so I tried to do this but there is a big hole on the bottom of the foot. So this time we used some AmnioFill. I did it again, dHACM fill and it's just a product with a cord in it. It has amniotic sac in it. It's a combination. So what it does is it gives you a broad range to be able to do it. It's something we can only use it in the OR because it's not covered outpatient wise. But then we did this and we went and packed it, nice granulation tissue. It helps in the combination of negative pressure in this. So good granulation tissue but I skipped the black part because I didn't want to show you all my things. We had to go back and take that out. We continued on with this but now we are in the pretty good place. Not too bad. He is doing well. Look at the bottom. Remember how deep that hole was. So we filled that in. I'm like kind of amazed. I didn't think I was going to save that because I had the amputation discussion with this patient as we all should. There we go, looking good. There is the bottom. There we go. Thank you. Thank you for that. I've done this like four times in front of audience and everyone is like just reading it, okay. Thank you. Thank you for doing that. Five days later, this is his other foot. This is his other foot. I'm like what did you do. I did nothing. I was just sitting at home doing nothing. I don't have to comment. You guys' moans and groans. It just does this. Are you kidding me? This was important for me and actually the last time I did this thing I did at SAWC last week is they blocked out this because I'm a San Francisco Giant's fan. If you see it's a bull dog with San Francisco Giant's emblem on it. They blocked it out. I saved his tattoo.

    I thought that was important, limb salvage is tattoo salvage. Anyway, we made a big hole in this man's leg. That's just muscle hanging out there. That's his gastroc hanging out of the wound. So we need to kind of get it together and pull together, so we decided to use dHACM again in the fill and we are going to do delay primary closure because we need to pull this together. So no matter what we are going to do, we need to cover some of these tendons and do that. So that was what we did. We went in and used it. I should have blocked that out. Sorry, but you couldn't read it as I clicked through it too fast. That's it doing it. And then we closed over. So we did that and we just did a closure over it but my resident cut because I want to cut blood vessels probably, cut every blood vessel in the foot. We talked about limb salvage but we can't do everything. If you look up above, that looks pretty well and my vascular surgeon as the story goes on, he thanked me. He said whatever you did up there, I thought it was going to be an AKA above-the-knee amputation on this because if you notice, his foot dies. And it's not a good story but it's a realistic story. So you just have to take the good with the bad with this and so he ended up again the foot died but he said he was able to close it and do this at BKA level rather than AKA because of the way we done the tissue on the primary closure. So it's good. But let's not forget his other foot. That foot that was almost healed. So now those two toes turned black. Dude, you are hurting me. We always liked these pictures. Why do we do this? This is not nice to take picture of toes off of it but it's like I'm sure vascular surgeon do that holding the leg. You probably don't do them but you've doing it enough time.


    You don't have to do it. We take these silly pictures you know just to show and it's always fun because when you are doing this on your phone and your children look at your phone and oh, dad, what did you do? Dad, are those toes? Yeah, those are toes. I probably do it for my kids more than anything else. It's just so sad. So anyway, we did the same thing. We did delayed primary closure. We used a fill product on this again and we closed over it. That's where he was last week. I took a video of him walking because he got his prosthetic on the other side and he has got his diabetic shoe with the filler on there now and he is great. He loves me. He is talking about we are going to go to Giant's game together. No, we aren't going to Giant's game together but that's okay. That's fine. He is a fan. I saved his tattoo. That was important. One more. This is always one that you get called -- I got called by the vascular surgeon who saves my butt all the time. So he dropped a cigarette on the top of her foot. Come on. He said Jim, I already I&Ded it. Just do some wound care on it. That's all you need. I already took care of it. Good, thanks. He took care of it. I don't have to go to the OR. Great. My resident sends me the picture. You did what? I don't have to do what? This was a cigarette butt according to the patient. But if you look at the rest -- look at all the way up there, necrotizing fasciitis, not a diabetic, totally sensate. These dressing changes are going to be fun. Have you ever seen a tibia outside of cadaver lab, that's what it looks like. When it died, you've to cut it out. So you clean it up. You could see the two holes in it. It just kind of went that way and we just took all the pus out. So what do we do? We start with negative pressure, again no fun because she is sensate. We pack it open to begin with, I don't usually put it on because I hate those calls from the recovery room. Dr. Stavosky, the canister is already full. Turn it off. Turn it off. I missed something. I have to go back and do it. If you are bleeding the patient out, that's not good. So I waited a day or two. I just do moist dressings and then we get the VAC on later. That's just my thing. You guys can do whatever you want but that's important. Good granulation tissue. Starting to use hHACM on it now at this point in time. So from there to there. I don't have the last picture of her heel only because she won't come back and see me. It's great. Just take a picture. I don't have that kind of fun. Anyway, so thank you very much. I hope you look at different things and when you are deciding you have options. Think about your options but don't forget good wound care. It's so important. Thank you very much.


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