Brandon Hawkins, DPM reviews some basic scientific principles on amniotic membranes and explains the hows and whys the technology works. Dr Hawkins also presents case illustrations to demonstrate the effectiveness of this treatment modality.
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Release Date: 03/16/2018 Expiration Date: 12/31/2018
Brandon Hawkins, DPM, CWS
CEO of Stockdale Podiatry
Medical Director of Bakersfield Heart Hospital Wound Center
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TAPE STARTS – [00:00]
Male Speaker: The next speaker is going to be talking to us about dehydrated amnion/chorion allografts in advanced wound applications and surgical applications. Dr. Hawkins is, I believe, you’re new to our group. I don’t think you’ve spoken for us before. We’re always trying to get new speakers to come in to our fall so we can become more enlightened and hear what new and exciting people have to say. That’s not to assume that you’re going to be new and exciting, but I look forward to hearing from Dr. Hawkins who – I didn’t get your bio totally. I think you’re from California, Stockton, Beverly Hills, Bakersfield, that’s quite interesting circle from Stockton to Bakersfield and Beverly Hills.
Anyway, let’s welcome to the stage Dr. Brandon Hawkins.
Brandon Hawkins: All right. Thank you guys so much. Yeah, I practiced in Bakersfield, California in part of a large group called Stockdale Podiatry. As well as I’m the Medical Director at one of our hospitals out there.
So what we’re going to talk about is the use of dehydrated amnion/chorion grafts in advanced wound healing, as well as in surgical applications. So this kind of ties into Lee’s lecture, but we’re on the far end and when we would decide we’re going to use these advanced techniques for these various wounds that have become very complicated.
So my disclosures, I am a consultant for MyMedics, I have to give that up. And the learning objectives, we’re going review scientific data so as with the amniotic membranes. We’re going to address the treatment pathways and the wound etiologies, as well as explore different amniotic tissue allografts and their configurations and how to use them in the clinical practice.
So amniotic membrane. We know the placental tissue has been around since the beginning of time. We also know that there has been published data in regards to the use of amniotic tissues in wound care. And years ago when I sat on the board of director for the Association for Advancement of Wound Care, we would send global volunteers to various countries to do wound care. And part of their protocol was actually to have live births and take that placental tissue and then put those placentas on various wounds.
So we know that there are various property associated with these placental tissue. What it does have and what they have shown is it has a barrier property. It also modulates inflammation. It helps to reduce scar tissue. And some of the key things is it helps to stimulate wound healing and has a central growth factors, but it also has a various immunological property associated with it to help with wound healing.
Now the dHACM process or the dehydrated human amnionic/chorionic process associated with this is a special technique. But in this technique, what they do is they gently wash and cleanse the membrane. And through this, they then dehydrate it, keeping all of the tissues viable as well as it becomes very bioactive matrix and then this allows you to keep it viable for a shelf life of up to five years. So you could actually put this on your shelf or your wounds center, forget about it, five years later, you can come back.
Now, scientific data. Dr. [Shoots] [0:03:23] came up with this standard protocol what he called were the three pillars of wound care. And what he said is that there needed to be three things necessary for a wound to heal. There needed to be some type of extracellular matrix, there needed to be cellular signals to basically modulate the wound and then there needed to be cells and they need to be bioactive cells. He never said that they needed to be living cells, but definitely bioactive cells.
Now, when we jump in to this, there are two types of amniotic grafts out there. There’s a first generation graft. And this first generation grafts are basically amniotic grafts and they are either cellular or decellularized. And then there’s the second generation graft, which is the cellular but it’s the dehydrated non-living graft. And both of these grafts have data published on them and they both have various uses in various applications in how they can be used.
Now the dHACM, some of the various properties or some of the growth factors associated with this and we’re kind of talking about the three pillars that Dr. Shoots had talked about. But some of the growth factors that are associated with this and there has been over 200 different growth factors I kind of teased out. But these are some of the more crucial ones. If we look at the Ang-1 and Ang-2 growth factors, they are crucially important for angiogenesis and tissue migration. If we look at some of these others ones like the platelet-derived growth factors, we remember that from the old days when Regranex was out, and we can also see that there are two other ones, the PGIF and the VEGF. These are important for proliferation and stimulation of angiogenesis.
But these are just a small portion of some of the growth factors that are out there but all of these have an essential and crucial portion to basically stimulating angiogenesis and wound.
Now when we look at an actual graft and this is just taking a small portion of some of these growth factors, but when we actually take a part of this graft and you look at the amniotic portion and you look at the chorionic portion, its’ the chorionic portion of the graft that actually has the majority of the growth factors associate with it. What it actually has is approximately 80% of all the growth factors in the chorion. So if we’re just using an amniotic graft, we need to be careful because we’re basically shorting ourself bout 20% of those growth factors that we need.
So biological activity. If we’re looking to heal a wound, we do need a bioactive matrix and so we take this dehydrated amniotic biotic matrix. And what we need from the human or from our candidate is we need all of these right here. We need the fibroblast. We need the endothelial cells. We need hemopoietic stem cells. We also need the mesenchymal stem cells and then we need the adipose stem cells. And combining these two, actually allows us to cause tissue proliferation migration and biosynthesis and thus we can get wound healing result.
Now when we look at stimulation of growth factor production, when we add these growth factors, and these are just a small component of this, but when we add these growth factors to an actual wound, what it does is it stimulates fibroblast. And then in return, these fibroblasts actually stimulate growth factors so it becomes this almost this cascade event where we are continually adding more growth factors to the wound, not only from the actual graft, but from the individual’s own portion of this and this is what allows us to have wound healing.
Now, type 1 and type 2 adipose derived stem cells, why is this important? Well, we are dealing with the diabetics. And if we are not stimulating these cells, then ultimately, what’s going to happen is that we’re going to not allow it. We’re not going to heal these people. But if we look at normal adipose cells and we look at them in a healthy individual, if we add the dHACM and we can see that all these components that we had talked about, both in migration, proliferation and the synthesis are there.
Now when we add both type 1 or type 2 adipose cells which have some inability to cause wound healing because they’re either been glycosylated or they have – they are very stagnant. But when we add the dHACM to both of these types of cells, we can see that just like the normal healthy cell, we still get the migration, the biosynthesis, and the proliferation. So it’s as if we had a normal living cell when we add this dHACM to these diabetic ones.
Now, kind of just in a brief summary and then we’ll go over some of the clinical portions of this. But when we look at the dehydrated amniotic and chorionic grafts and we look at the three pillars that Dr. Shoots had talked about, it does contain an extracellular matrix. It does contain all of the growth factors, the cytokines and the kenokines that we need for wound healing. But some of the more crucial portions of this is that it actually stimulates various types of cells. It stimulates both the adipose cells. It stimulates the hemopoietic cells and the mesenchymal cells and then through this, we’re actually stimulating the person’s own body to cause migration proliferation and then wound healing.
Now looking at some clinical case examples associated with this. This is our first patient and what I should say is that the dehydrated amniotic/chorionic graft comes in various types of grafts. You can either have a mesh type. You can have it in a liquid form. But there are various ways in which you can actually use this.
This patient right here was a 59-year-old diabetic male who had a previous history of incision and drainage with a dehiscence. And this patient have disappeared off the map for some time and decided to finally come back when his wound wasn’t healing after months. And because knowing his history that he was a very non-compliant patient both in his glucose control as well as he also had a history of peripheral vascular disease, we opted to use an injectable form of the graft. And after two weeks, we had complete closure. Now this wasn’t a large wound, but again, this was a non-compliant patient and we knew that if we had put a standard mesh graft or something like that or sheet graft, then he would probably remove this. So we are trying to get the optimal amount of wound healing by using an injectable form.
This right here was another patient although not diabetic, this patient was an active smoker.
A 68-year-old male who had a history of smoking approximately a pack a day. He had a previous tendo-Achilles performed or lengthening performed by another physician ended up dehiscing and had been there for approximately, I think, about six months. And he was referred to us. Again, not knowing his history and also knowing that he was a active smoker and that he was not going to give this up, I opted to use an injectable form. And you can see, although the wound was relatively small, at about one week, we already 72% wound closure and by week two we had complete wound closure.
And this was our third patient. You can see this, again, was another patient who had – non-diabetic but had severe peripheral vascular disease and had an ulcer to the posterior aspect of the heel. Although the Achilles tendon wasn’t exposed, it was relatively deep, almost to the peritenon. He had other comorbidities, but again, we opted to use the injectable form because this patient was non-compliant. And you can see by week one, we had 96% of wound closure, and by week two, we had complete wound closure.
Now, this is our final one using the injectable form of this. But this was a 59-year-old female who had had a previous amputation and again noncompliant patient who disappeared off the grid after she had her amputation. The wound had dehisced, the patient decided that after a few months, this is not healing, decided to show up. And so again knowing she was noncompliant, we opted to use the injectable form. By four weeks we’d went from a relatively large wound to pretty much insignificant.
Now, all these patients we followed a year later knowing that just like Dr. Rogers had talked about he know that the future of this is keeping these wounds healed and following each of these patients over a year’s timeframe all of these wounds that we had have remained healed. Now this data was presented at SAWC approximately two years ago. And what it basically showed is that across the board usually within two to three weeks or two to three applications that we were getting wound – complete wound closure or at least 98% wound closure, so.
Now, these cases are a little bit different than the other cases, these individuals were referred to my wound center. Now these patients, most of them if not all had diabetes, but the problem with these individuals is that they had severe peripheral vascular disease where they were already in line to have an amputation or below the knee amputation and this was their last resort. They had been referred to vascular, endovascular – alright excuse me, interventional cardiology and these patients were non-candidates. And so our job was to at least hopefully try to help them in some regards if not at least try to heal him.
Anyway this was a 71-year-old who was referred to us with an exposed tendon and again like I said he had severe peripheral vascular disease. And when you look at this, this right here is the exposed extensor hallucis tendon. Now, we had some good granular tissue on the side components of it, but again we had complete exposed tendon. So what we opted to do was debridement, remove the biofilm, we began applying a mesh graft and you can see over a 175 days it took to heal this wound and yeah that is a long time but what you’re looking at is individuals who had no circulation, they had minimal to no circulation at all and so we were dealing with basically an uphill battle.
It wasn’t dealing with infection, it wasn’t dealing with offloading these patients. It was that we had no blood flow to get to these patients. And so what this is basically showing you is that using the dHACM and going back to previous portion of this lecture, we’re showing that It does stimulate angiogenesis. Now, maybe not on 0impactful level where you see, bam, you know, shock and awe, but we’re seeing in these patients who this is their last resort, they’re in line for some type of amputation.
Now, this is our next case, this is a 62-year-old who was referred to us, had a chronic history of diabetic foot ulcer and had multiple problems including ischemia and peripheral vascular disease and had a previous amputation. Now, if you look at this, this is the posterior aspect of the heel and you can see that there is actually exposed bone. And so again patient had no circulation. Our only options were either to try to use the dHACM or the patient was going to go on to the below the knee amputation. So we debrided this, cut a portion of the calcaneus just enough to where we could start applying this, we began applying the dHACM over the bone and it took us approximately 84 days.
But you can see by the end of that 84-day treatment, we had complete wound closure, no signs of osteomyelitis and the patient was back to normal activity.
This is our next case, it was a 64-year-old male with history of chronic diabetes. Now this patient had multiple problems because he had not only peripheral vascular disease, but he had venous insufficiency so he was swelling as well as we had no circulation. And when you look at this wound, you can see that there is exposed bone. So there is the metatarsal head sticking out there and this individual had already been referred to vascular and they – he was not a candidate.
So again what we try to do was we debrided some of the fibrous tissue and began applying the mesh graft and it took us approximately 55 days, but you can see by the end of the 55 days we had about 96% wound closure. And this is, you know, something that for people who have no circulation and no other options, this was a really good outcome for this – at least for this individual.
Now, this is probably one of my more complex ones and in that, this patient also had diabetes, was non-compliant, had sugars ranging between 200 to 300, he was seeing an endocrinologist but they could never get the sugars down. He’d also been seen by vascular, but because he had severe peripheral vascular disease and he also had venous insufficiency and was swelling, he wasn’t really a candidate.
And so he was referred to us and he had this large wound on the lateral aspect of his foot and when we initially first saw him you can see that there is both gangrenous tissue and then there’s fibrous and granular tissue. So we began debriding this. And the moment we began debriding, we began applying the EpiFix because again we’re trying to stimulate this wound with growth factors and we’re trying to get the angiogenesis going.
And you can see by day seven, we had increase in granular tissue, less fibrous tissue and then by day one – what is it day 70, we had almost complete granular tissue. The only problem is now we had exposed tendon. Now, we opted not to take out the tendon. Instead we began applying the graft over the tendon in hopes that this would, you know, bridge over this and you can see by about day – what is it – by day 126 the graft had caused a granular bridge right over the tendon.
Now in the old days, you remember they would always tell us we can’t apply any grafts over tendon. In this case, yeah, you can. And you can see, yeah, it took us approximately 165 days to complete epithelialization, but again this was this person’s only option. He was looking at some time of below the knee amputation and, you know, he went on to be pretty healthy.
Now, this is probably one of my worse cases, this individual was referred to me from one of my friends in the ER and the problem with this patient is that he’d already had an AKA on the left side and so when he came in to the emergency room, my friend calls me and says, “Hey, you need to do this transmetatarsal amputation.” And I said, “Well, is there a vascular work up?” “No, he’s not a vascular candidate.” I said, “Well, what do you want me to do?.” And he’s like, “Well, he needs his foot because he lives in a trailer park, he needs some type of foot to help him ambulate, to get around this trailer because otherwise he’s looking at, you know, being some type of skilled nursing facility.” And I said, “Well,” I said, “You know, I’ll try.” But I said, ‘It’s probably going to go on some type of higher amputation.”
So we did this transmetatarsal amputation and you can see one week later, these top photos show that we had a complete failure. Now, what I failed to mention is that this person was an active smoker and when I mean active he was smoking at least one pack a day. When he came back for my – when his first post op visit, he was still smoking outside my office and then when he left he was still smoking.
So we had a complete failure because of his smoking habit and he would not stop. So the individual, we talked to him about potentially doing a below the knee amputation and he said, “Look, just, you know, try to save my foot, I just need some type of limb to get around.” And so what we decided to do was do a revisional transmetatarsal amputation and apply the dHACM and you can see this is week one postoperatively after we applied the dHACM and this is him still smoking and I’m not an advocate for smoking, but there is something to the graft in that it had caused some type of angionesis to him and you can see that we had almost perfect granular tissue.
By week two, we had almost complete epithelialization and he went in to complete wound closure.
Now I’m not advocating smoking, but what I am advocating is that using a dHACM in these patients who have severe peripheral vascular disease, its purpose is to help with angiogenesis in these complex type patients.
Now this is one of my other complex patients. Now the difference with this patient is this patient was initially referred to a skilled nursing facility because she had had shoulder surgery and she had type 2 diabetes but it was relatively, quote, “controlled” and she had ended up a small skin tear and what had happened is the skilled nursing facility had wrapped that skin tear too tight and caused this ulceration and you can actually see that there is the tibialis anterior tendon completely exposed.
Now the skilled nursing facility had initially referred her to ortho and their choice was do a below the knee amputation. They didn’t care about any kind of wound care. She was then referred to vascular and to plastics and their option was we could cut the tendon out and we’ll do either free flap or skin graft and you’ll end up with a foot drop but, you know, at least you’ll have your limb.
And her thing was look, “I went in for a shoulder surgery and I’m coming out with either a foot drop or missing leg.” And so she did not like either of those options. So she was referred to our office and what we decided to do was to try the dHACM to see if this would help, knowing that the tendon was completely exposed.
So what we did is we debrided the tendon peeling off all the peritenon. There was no more peritenon, so no more vascularity associated with this tendon. And you can see, after we had post debrided it, we apply the graft and it’s the mesh graft out there. By week one you can see – this is one week after she had seen us. You can see that there is a granular bridge crossing that tendon. So something in this graft had caused this granular bridge. And you can see by two weeks, we had almost complete granulation over the tendon.
Now she went on to complete wound closure in approximately four weeks. And, you know, for her this was a miracle because she was looking at either an AFO for the rest of her life or she was looking at, you know, a below the knee amputation. So anyway, I want to thank you guys and hopefully you have a great week.
TAPE ENDS - [22:35]