Section: CME Category: Wound Care

Advanced Allograft Applications - Current Amnion Technology and Applications in Foot and Ankle Surgery

Christopher Bromley, DPM

Christopher Bromley gives an overview of amnion and chorion grafts. Dr Bromley reviews the types of grafts available, followed by a variety of case presentations to appreciate the beneficial effects of dHACAM.

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Goals and Objectives
  1. Understand Amnion and Chorion
  2. Differentiate the different Amnion/Chorion allograft options available
  3. Understand the mechanism of action and effect on wounds both surgical and nonsurgical
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  • TAPE STARTS – [00:00]

    Unidentified Speaker: Another interesting approach to the use of dHACM dehydrated human amnion/chorion matrix. For illustrating surgical procedures and how you might be able to have better results and decrease the healing time. So we have our one of our favorite dHCAM speakers. [Off Mic Conversation] No, just one. I have to be nice to everybody. Christopher Bromley

    Christopher Bromley: Good morning. Thank you very much for the invitation. Davis Shuck [phonetics] was very informative -- I tell you I've had ultrasound in my office for about five years and I don't know what I was doing for the 20 years before that because it's really an invaluable tool. And I think that his approach to percutaneous debridement is very valuable. So as I said yesterday to some of you in the workshop that I did it's very interesting to me that the amount of lecture on amnion in this particular meeting is amazing. So hopefully, we can kind of pool all that information together and answer some of your questions as we move forward today. So from the disclosure perspective, unfortunately I don't own any of the companies that I work for. I do work as a consultant for MiMedx and number of other amnion companies. I have about five years of experience that two years sort of, needs to be updated. So the goal for today's talk is to understand the difference between amnion and chorion, to differentiate different types of grafts that are available and understand their mode of action. For all the different amnion companies that I have worked with, there is really no bad amnion. You have companies out there that say amnion is great, chorion is great. If you use one, don't use the other. Dehydrated is good, live is good. They're all signaling devices. These are some of the things we talked about yesterday in the workshop. So what is an allograft. Basically, amnion is an allograft. It's tissue that we harvested from donated placentas in very safe ways. Xenografts are those that we take from obviously different species. Milestones and tissue banking. We have used amnion and placental allograft for over 100 years in Medicine. Around the 80s, late 80s when HIV really became an issue, the FDA got involved and eventually the American Academy Tissue Banks to determine the safety. And even to this day, some of our donor sites like University of Miami Tissue Bank. These centers are very aggressive in making sure that these grafts are safe. They're even testing for Zika now because it's obviously in the news. There has been no disease transmission. No patients are at risk. So what type of allografts do we use in podiatry and in foot ankle orthopedics. We obviously use bone, bone matrix, cartilage tendon, acellular, dermal matrix, dermis. And also of late in the last five years, we have access to amnion and chorion. There are obviously a number of studies out there that prove that it's safe. Placental allograft is basically a very, very thin. It's the inner lining of the placenta. The chorion is the outside of the placenta. If you have ever had experienced to hold the placenta, it's a very elastic structure. It's very unique. There have been some studies out there that showed that there was some immune response to chorion. Most of the companies like the ones we have here sponsoring the lecture have figured out a way to process the chorion. So they removed all the maternal DNA so that there is no chance of immune response. Basically, the goal is to use the tissue to stimulate the body to heal. It's a signaling device. And what we're looking for, excuse me, is to reduce inflammation to minimize scar tissue and stimulate the repair. As in the prior talk, the doctor was using the needle to debride the tendon and then he was backfilling his debridement with amnion to stimulate the repair. I'll talk about some of those approaches as we move forward today. So if you look at amnion and chorion, they both have growth factors. On this particular graphic in the red, you can see that there is a significant increase in the growth factors and chorion and that’s basically because of its structure. It’s a much thicker structure than amnion. And together they work very well and together they -- it's probably what I use 90% of the time is the amnion chorion together as opposed to just straight amnion.


    So for those of you who -- looking at the graphic, you can see the fetus and you see the amnion is the side against the fetus and then chorion is against. You can see the very thick graphic here. This is the thinner amnion. And then you have all these different growth factors that are present in that chorion layer. Basically, the goal of our using amnion allograft is to stimulate the cells. What we find in our wound patients as well as our surgery patients is there is this inflammatory phase. We know that our diabetic ulcers get stuck in the inflammatory phase. So what we're doing is we're going to introduce the amnion chorion graft on the wound or in the wound or under the wound to stimulate the cells in the local environment. This is the cell communication. And we can also stimulate the body far away from the wound to sort of advance the healing cascade. If you look here, we have all the recruitment that will go on. So what happens is we have chemokines here and then we have normal wound healing process. So we're going to accelerate this process because we have introduced the signaling device which is what these are and it's going to recruit in your T cells and your neutrophils and monocytes. It's going to bring them into the wound and get this whole process going. I tell patients it's kind of like miracle grow for plants. It's kind of like miracle grow for people. So what types of grafts do we have available? For the last five or so years, we've had access initially only to dehydrated. And dehydrated was the most efficient way to process the graft and then over the last few years, we've had advances in using cryopreserve. The advantage of dehydrated obviously is it has a five-year shelf life. It's easy to handle. It's easy to ship. The cryopreserve stuff we use -- most of the times we're using cryopreserved cord or flow. We're using that -- the disadvantage is it has to come from a freezer. We do have a freezer in our practice in our clinic that we have access to, but it definitely has to be shipped in and has a shorter shelf life of about two years. So where do we use it? Basically, in our practice, we have -- in in-office use, we use it as an alternative to cortisone. In the surgical setting, we use it as to augment our surgery. So we'll go over cases later on in the presentation where we're doing open cases and using a membrane to support our repair. And then we also do it in the operating room as a percutaneous approach. Similar to the last talk, we do percutaneous debridement with Tenex. Those of you who are not familiar with Tenex, we'll show you some cases. It's basically a percutaneous ultrasound debridement tool. It was originally developed by ophthalmologist. It was used in the eye and it would basically dissolve the cataract and suck it out. And some very smart people at the Mayo clinic figured out a way to take that same tool and use it in the orthopedics. So this is what happens. Obviously, there are moms who are in the donor programs. They're screened throughout their pregnancy and then placenta is harvested. It's again screened and it's screened for all of the things you see here as I said it's very safe. The benefits and the reason we're using it is we're looking to minimize our scarring, reduce fibrosis and inflammation. There are also antimicrobial properties present as well. So these are some of the initial -- the ophthalmologist back in the late 40s or early 50s were really the first ones to use it followed by oral surgeons. And we've been using it in wound healing, and now we're using in our open repair. There are gazillion companies out there now that make this product. A lot of the products come from the same source. They're different. Couple sites are in the country. There are 57 different growth factors that are the key growth factors. There are almost 260 that they have researched overall, but these are the heavy hitters. These are the ones that do most of the lifting. We'll go through some cases. This is a nice -- before the break. We're going to go out and have the snack. This is showing you foot that presented to an ER. These are feet that 10 or 15 years ago we would have probably been talking about BK. But with good surgical debridement and then after the debridement, we'll go ahead and put the amnion on right in the OR. I'll use often times the dHACM with the VAC and I don't put any kind of membrane over the dHACM. I'll go ahead and lay the dHACM right into the wound.


    And then I'll put the foam right on top. I don't want anything between the wound and the dHACM and nothing between the dHACM and the VAC. Patient will come back. We'll change the VAC and you can see in a very short period of time where a foot we would have removed is obviously goes on to heal. So the key with amnion when we're talking about wound patients is wound debridement. One of the biggest mistakes that podiatrist and other specialist have is they're afraid to debride aggressively. This device doesn't work. This is a signaling device. DHACM doesn't work if you don't debride. You got to debride your wounds, so it’s a nice beefy granular base. If it's bleeding too much and you worry about sloughing off your graft, put a compressive dressing on and then come back in 10 or 15 minutes later and then reapply. This is an example slide showing you the preparation. Make sure -- one of the things I brought up yesterday when we were doing workshop is make sure that you do a really good job placing the graft in the wound. This is not well applied. You see how the graft is overlapping. The dHACM has an epithelial layer and you want to make sure that the edge of the graft lines up with the edge of the wound. So I would do a better job placing this. Also one of the things that we addressed yesterday was initially we would put a piece of Adaptic here. I don't use this much Adaptic because every now and then the patient would come in and the whole graft dressing was slit around the side of foot. What we do now is we take a much smaller piece of Adaptic and put it right over top slightly larger than the graft. And then we use a nice big thick piece of filter foam and we stick it right to the foot. So it keeps it from sloughing off. I don’t use the dressing like this any longer. We use a much smaller dressing. And then we use some Kinesio tape to keep the whole thing from sloughing off and then do a good offloading. So the key factors to remember from this side is to do a good surgical debridement, make sure there is no fibrosis left, excellent graft placement and then offloading and make sure that it stays where it is supposed to stay. There is no way couple of Steri-Strips are going to hold that. Expectations would be that the patient would come back. Typically, it's going to take one or two applications and you'll go ahead and reapply next week. If you look at -- this is a randomized study showing standard of care which is wet-to-dry dressing that in this particular foot diabetic with dHACM, they had a 92% heal rate at six weeks versus 8% for the control which is significant. This is a long-term follow-up so that we get them to heal quickly but how will they hold up. We look at this particular study you see that 94% remained healed out at 12 months which is excellent compared to the control. So not only we're going to get them to heal faster, but it's much better quality. So it doesn't make a difference if you apply it every week or every two weeks. If you look at this particular study, you'll see that when you apply and did surgical debridement and application of dHACM weekly versus biweekly that healed 41% faster. So there is benefit in making sure that patient comes back each week, do a good surgical debridement and reapply. This is a multicenter study looking over a period of time, looking at -- these basically took all the patients I did debridement and they healed quite well with weekly applications as opposed to Apligraf, which is a much longer healing and a much more expensive modality. And nowadays, we're all going to be paid on outcome. So we need to get our patient better quickly, and we need to be very conservative in reference to how we spend our dollars. This is just the overall explanation of their exclusion criteria and these are showing the results of DFUs. So 85% of dHACM were healed at four weeks versus the Apligraf and standard of care which is wet to dry was here. Complete heal ratio at 95 at six weeks which is only 45% for the Apligraf. Number of grafts used; you can see for the entire study, there was a much higher cost for the Apligraf versus the dHACM. So overall cost much less for the whole study and per patient cost significantly less and lot less waste. We know from the previous talks at the average diabetic foot ulcers about the size of a dime when we have to waste graft and spend more money for it. That's not the best use of our healthcare resources. Other applications, in our burn centers, you know, we see good results by about three or four weeks. Exposed bone, it is possible and approved to use dHACM over bone. We do have ulcers, you'll see it's an excellent modality to get some granulation tissue.


    These are some cases. It’s a patient who after bypass had a basically a breakdown with amputation. And you'll see here good surgical debridement. You go ahead and put the graft, line the edges up. And you'll see that they go on to heal quite well. This is obviously amputation. I've got a quite a significant wound healing. You go ahead and put the dHACM on. You get a nice beefy granular base and then you can go ahead and apply your split thickness graft to follow. It's some other cases. This is a dHACM again. Go ahead and debride this. Get all the stuff off. Put the dHACM on and then put the VAC run on top of the graft. And this patient went on to… Some of the surgical applications -- over the last few years, I had attended a lecture initially by a plastic surgeon. He was using at maxillofacial cases. So I thought if he can use it in the face, I can obviously use it in the foot. So one of the biggest complications after bunion surgery is the stiffness around the first metatarsal phalangeal joint. So what I do with the dHACM is after the bunion is complete is we layer the graft over the bone and then close the capsule over top. And you'll see that recovery time is significantly less and you don't have any of this stiffness. This is that same patient. Postop, you can see they did quite well. There is a very little swelling, little bit of bleeding through my monocryl, but overall they do quite well. There are other types of dHACM available. And some are more flexible than others, but basically the approach is the same. You get all your surgery done and then you lay the dHACM right over the bone and then close overtop. You can see the technique. First few times you use it, you got to get used to the handling characteristics. It's little stiff. You put one or two drops of saline on it and it basically hugs right down to the bone. You see very carefully placing and then close overtop. I always tell the residents once we get it in place, don't touch it because they have tendency to want to mess with it. We have obviously other techniques we use it as a wrap for tendon and nerve repair. Basically, we make a little burrito technique and we slide it underneath, lift up and then we basically wrap it around. This is an extensor tendon. Basically, it was an overlapping fifth toe. There was a very little left since it was redo of the extensor tendon. So we did a long Z lengthening and then wrap the dHACM around to support the tendon repair. So you can see this is the burrito technique. You kind of slide it underneath and then wrap it over top. Then we put some Vicryl around it to kind of hold the whole thing together. You can see the bridge wrapped around. These are just -- I'm showing you about 10 days out. This is Lisfranc staple and ankle mass. Basically, these patients healed very-very well and the recovery time is significantly less and very little swelling afterwards. I don't know about you but one of my least favorite things about neuroma removal is the ball of scar tissue that you got. So in this case, you can see we've removed the neuroma and then we basically lay the dHACM down in that wound and we get significant less pain and we don't have that big ball of scar tissue that occurs. Similar to the previous lecture, I do a fair amount of ultrasound guided debridement of plantar fascia, Achilles, posterior tibial peroneal. And after I get done with the ultrasound debridement with Tenex, we backfilled the area with dHACM. One of the things I mentioned yesterday in the workshop, good idea to -- after you're done with your debridement, sew this hole closed. I made the mistake one time of doing this really great debridement and I'm watching the ultrasound and I turn the lights on. I'm covered with dHACM because it squirted out the hole and hit me in the chest. So I learned from my mistake. Go ahead. After if you do this procedure, go ahead and sew that close and then come in at a 45-degree angle and use your dHACM. Also, there is a term in real estate called location, location, location. It’s the same thing with dHACM. When you put this in, use your ultrasound and make sure that you're placing the dHAC. If you're backfilling the tendon above or below. Unlike the previous speaker, I don't put anything in the Achilles. If I'm doing Achilles debridement, I go in the paratenon. I don't violate the tendon. This is some cases for ulcer. Lou Freed [phonetics] who suggested to me a couple of years ago that we use Tenex to debride ulcers. So this is an ulcer that failed with topical dHACM because of its location, diabetes, the PAD. We went ahead and took this patient to the operating room and debrided underneath the ulcer with Tenex. And then I backfilled this area with dHACM. You can see this is one and two weeks postop. The whole area is totally different. There is so much less inflammation and the ulcer which I couldn't heal no matter what I did to it for about a year went on to heal. Interesting that this guy -- his son is a plastic surgeon and about two weeks after I got his dad healed, he came in to my operating room and he goes what the hell did you do to my dad? I said what you're talking about. He goes how did you do this? Can I use it in plastic surgery? And he is using dHACM to support his plastic surgical stuff now. This is an example of using the dHACM. I had a patient who a significant history of keloid formation. I had to do a pretty simple arthroplasty, but I thought to myself this might help and it did. I just basically put it underneath the skin. It healed really well. I think it’s the only surgeries I have ever had that didn't end up with keloid. So overall from the surgical approach if you are using dHACM, you'll have significantly less pain in your patient. You will have a much faster recovery. Most of my forefoot surgery which would typically take six or eight weeks to get into shoes by about three weeks. Overall the tendons will scar significantly less. When you're using the dHACM, they will slide a lot better and you'll find overall very pleased. It's an excellent tool in your toolbox. So again it's very safe. There is no disease. It's an excellent adjunct to our surgical approach whether it's diabetic ulcers or open cases. And I think you figure out what products work best for you. I use dHACM, the amnion-chorion and dehydrated more than the cryo. If you have any questions, please feel free to e-mail me or call me. I do live on East Coast. So call me before 10:00 o'clock Eastern Standard Time, because I have to [Indecipherable] [00:21:36]. Thank you.


    Unidentified Speaker: I have one question for you Chris. When you are injecting this, is there a special or specific solution that you use as 3 cc syringe or is it 1 or 2 cc per vial. What exactly is it that you are doing.

    Christopher Bromley: That's an excellent question. So typically dHACM if you're using a micronized for injection, you're going to want to rehydrate it. And you can rehydrate it with saline which is what I recommend. You can also use lidocaine. If you do use lidocaine, make sure you use a single dose vial so that it has no preservative and I usually use about 1 cc. In the beginning when I started doing this, I thought to myself, well I could do just one shot, mix the local with the dHACM and give it to the patient. What I found over the past two years I do a much better job if I do a block proximal and then just do the saline because I could do a much better job. I typically can push it through a 25 or 27 gauge and I use a 3 cc syringe because I can do a much better job controlling it. But it's again, it's all location, location, location.

    Unidentified Speaker: One vial of micronized --

    Christopher Bromley: You will get the number of milligrams and you just use about a cc or two of saline.

    Unidentified speaker: Okay. Any other questions?

    TAPE ENDS - [22:58]