Christopher Bromley, DPM discusses different types of wounds, factors involved in wound healing, as well as strategies in choosing the best wound care option. Dr Bromley also reports new wound healing options that are available.
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TAPE STARTS – [00:00]
Male Speaker: Dr. Chris Bromley comes from Poughkeepsie, New York, Vassar Medical Center. He has a lot of experience in wound care and the latest and greatest new products, has a great deal of experience in this regard.
So he's going to talk to us all about Making Sense of Wound Care 2019. Often, a very difficult matter that keeps raised. So let's welcome Dr. Chris Bromley.
Christopher Bromley: Thank you.
Male Speaker: Okay, my friend.
Christopher Bromley: Okay, thank you.
Male Speaker: Go ahead, my friend.
Christopher Bromley: All right. Thank you very much, Present, for having me back and for your attention. So today, we're going to spend a little bit of time sort of trying to make sense of what our wound care options are for 2019.
A little bit of housekeeping. Objectives today is to sort of understand, and since this is a CMA talk by nature, review what factors are involved in wound healing because we do need to be reminded. What types of wounds we're going to treat and what your wound care options because there are a plethora of them. And then, what to use when. And what, say, for the very end, some of the newest options we have and the keys to success.
From a disclosure perspective, I have none – this particular talk is underwritten by Present. I don't own any stock in any wound care companies and I do as much lecturing as I can so that my ex-wife can live a lifestyle of which she became accustomed.
All right. So what is the overall impact of wounds here in the United States? The total medical management costs for diabetic foot disease in the United States is estimated to be at least $13 billion and that doesn't include the management of diabetes and the cost of insulin which is in the news of late. The estimated diabetic patients, 85% of all amputations occurred because of a diabetic foot ulceration or a form of gangrene.
One of the things that we have to be cognizant of as we make our wound care choices is how we're spending our wound care dollars. I help run a five-hospital system and we live and die based on patient outcome and how much money we spend. And one of the things that you need to be aware of when you're making wound care choices is what choices are you using, you know, how much does the wound care product costs, you know, what is the success rate, and how you're using those wound care dollars and you need to be able to use them wisely. If you're not using resources wisely, the government will eventually find something else for you to do.
All right. Average costs to treat a diabetic foot ulcer is about 42 – $44,000 and this occurs in about 25% of all diabetics. So this is a very expensive disease to treat.
We, in the foot and ankle practice, will see more diabetic foot than anybody. And I think the second most common thing we see in our practice is the result of chronic venous stasis. I give a lecture – I haven't given it yet this year on chronic venous insufficiency. And I implore you, if you're not familiar with it and you're not looking for a chronic venous insufficiency, you should because it's actually as prevalent as some of the diabetic foot disease that we treat.
So to – as this is a CMA talk, you know, remember, you know, what goes on normal wound healing. We do have an inflammatory phase, and we see the different phases of angiogenesis, and the extracellular matrix, and the proliferative phase. The reason you remember that we have these wounds that won't heal is because the wounds get stuck in that inflammatory process. And you might remember for some of the other talks we did, the reason that we get stuck in the inflammatory process is because the autonomic nervous system, which is involved in all wound healing, gets stuck. There's an imbalance between sympathetic and parasympathetic systems and that's why you're stuck in that inflammatory cycle.
So what happens to these patients?
These are – we have chronic wounds. We have delayed healing because we're stuck in that chronic inflammatory stage. We're stimulating macrophage, as in neutrophils and then we see this activation of – and release of cytokines. All of these, this process, this repeated – this vicious circle is going on and we have MMPs and just basically these impaired – the whole thing becomes stale and we're not getting cells to differentiate, and we're not getting the blood vessels, we're not getting angiogenesis, and we're not progressing forward.
All right. So what is advance wound care? What do we have at our disposal in 2019? Obviously, wound care is very, very specialized. Particularly, it is in our purview to understand all of the different factors. And if we look at patients, honestly, we can tell we're going to be faced with all these different conditions. Most of our patients are older. Obviously, we'll talk about the prevalence of diabetes and the role of arterial disease, and venous disease, and neuropathy. And then, there's an overall patient compliance.
So there are a number of things involved. We have to – if we're going to be involved in doing good wound care, understand all the different areas that are going to be involved and all the different specialties that we can work together to have a great team approach.
So venous stasis ulcer is obviously common to us and we see venous stasis, it's also one of the things that we have to remember about these is why they occur. I was lecturing for many years on peripheral artery disease. And it wasn't until we started at pneumatic compression that I realized that the reason chronic venous insufficiency in venous stasis has also occurred is because of this – the blockage on return.
You'll remember that the – we were taught in school that the reason the blood returns to the heart is because of the interstitial pressure, the pumping of the muscles in the legs and then the valves and the veins. Well, if you have elevated pressure on the venous side, what we call as chronic venous hypertension, there's no flow back or a reduced flow back.
And what happens is, and this is so much more common in peripheral artery disease, when you have venous hypertension, you don't get perfusion of the wound bed. So if you're treating a diabetic ulcer and – or venous ulcer and you're not looking for chronic venous insufficiency and you're not treating it, it doesn't matter what you put on it. You could put a $4,000 allograft on it. If you're not treating the chronic venous insufficiency, you're not going to get it to heal. So you've got to look at and understand why venous ulcers are occurring and what the role of chronic venous hypertension is and – just think of it this way. If you've got a drain in your house and your sink isn't draining out the food, it doesn't matter how much water you put in it. It's not going to get any better. So this chronic venous hypertension is something that we really need to be more aware of and really involve in a treatment and we'll talk about that as we move forward.
So venous stasis is also, as you're all familiar with, there's – remember, there are different stages of venous disease. This is obviously late stage 6. We see these open ulcers, very painful, very, very hard to treat and you can put wound care products on this. So – nah. There we go. You can put – which you got laser – you can put all the wound care products you want on these. But if you don't treat the underlying disease, it's not going to heal.
Arterial ulcers. Obviously, these are more rare. We, you know, we were seeing more diabetic foot and more venous stasis. But obviously, very important, we've got to get the leg revascularize in order to have any success in treating these. These are ugly.
All right. Diabetic ulcer is where we're going to spend most of our time. Obviously, the difficulty with these particular patients is multi-factorial. We have an arterial component, usually, a small vessel disease. We usually have a venous because of the neuropathy. We have autonomic neuropathy and then we have a wound.
The – obvious – the biggest thing that we're looking at now, moving forward, is the numbers are staggering.
The – we're expecting a growth in diabetes 165% between 2000 and 2050. So if you look at where we are here, you know, we can see that still, we're – you know, we're looking at 14 or 15 million diabetics. We're going to see a significant increase. And I think we all look at our patients and understand why. I mean, people are more sedentary. People are more obese. They're not active and they've got multi-factorial risk factors.
All right. We can see it's significant, obviously. We're all familiar – pretty familiar with that. If we were – have a diabetic that loses a leg, most of them will lose the other leg within two or three years, and maybe four or five, and then eventually, expire.
So the amputation mortality rates compared to cancer. We can see that the – patients with amputation diseases or diabetes rate higher than most of the cancers. You can – a typical diabetic presentation as you've seen or I've seen in the practice.
All right. So what are the factors? Again, remembering we've got to evaluate the patient whether or not they have a soft tissue infection. Go ahead and treat that. Obviously, very important to understand, bioburden. If you've got bacteria in the wound and you're not treating that, you've got to get a hold of that because it's obviously going to eat up all of the nutrients.
Systemic illnesses. You know, if a patient's got a – his hemoglobin A1c at 14, it doesn't matter what you're putting on the wound. They're not going to get better. So you've got to get a hold of that. Do they have an underlying osteo?
Nutrition. We don't spend enough time talking about nutrition. I mean, it's pretty simple to recommend to your diabetics that they, you know, they have the right diet, that they're on a probiotic, that they're taking a B vitamin, you know, you – it takes just very little time to talk to them about what it is that they're eating and what they could add to their diet to help on the wound healing perspective.
Obviously, the wound environment, we'll get into as we move through into the wounds. Is it wet? Is it dry?
Do they have leg edema? Again, we talked about that. If you’re not treating the leg edema, you’re not going to get good arterial performance.
Compliance, we’ll talk about that in reference to the role of total contact cast. The perfusion, we talked about oxygen, we talked about the benefits of hyperbaric and also chambered oxygen treatment.
Debridement. The most important thing about wound care, and you’re all here so I’m sort of preaching to the choir, is the debridement. It doesn’t matter how great the allografts are, if you don’t do good evaluation of the wound and do good debridement and removing the bioburden, you’re not going to get anywhere.
So whether you’re using a 15-blade or mechanical debridement or enzymatic debridement, these are the most important things. All of the wound care products that we have will fail if you’re not debriding them up.
Now, I spent about 14 years helping run a wound care center at one of our local hospitals. And I really liked hyperbaric oxygen when it came out. And I still don’t dislike it, but I always refer to hyperbaric oxygen as a nice way to offload the patient two hours a day, five days a week. The oxygen was helpful, but I think that one of the reasons why we had success in hyperbaric medicine is we saw the patient five days a week and did a good job.
But it is – I think in those refractory patients that are non-bypassable, that have significant arterial disease, that they have osteo and we’re not getting good perfusion, I think the hyperbaric medicine is still indicated, although we see Medicare and some of the big payers taking a closer look at how we spend our healthcare resources. And unfortunately, hyperbaric medicine is not without complications and it is extremely expensive.
So there are some newer topical oxygen products. This is a product that we’ve used in our practice, topical oxygen. When you look at the studies compared to gold standard, it’s about four times more effective. They have great success. The advantage of using these smaller chambers is they’re a lot less expensive.
Patient doesn’t have to leave the home. They can have the treatment at home. You can introduce an antibiotic into the environment so that you can moisturize and treat infection, keeping that bioburden down.
So they’ve had some excellent success. You know, when you look at topical treatment versus standard of care in that 12-week period, there’s been a couple of good studies. These are multi-factorial, multi-centered studies showing good effect. The only downside of this is we’re still waiting for Medicare coverage which they keep telling us is coming and it’s coming, but for some of the private insurance and Medicaid patients, this has been a nice asset and a good tool in our toolbox. And it really fits into the what we can do to help with the wound healing.
So, again, the key components for oxygen, the important part is if you’ve got a patient, whether they have – whatever level of arterial insufficiency, the diabetes is always going to affect the small vessels. So evaluating the patient as to whether or not they’re smoking or not. My personal policy on smoking is if you smoke, you stop or you find somebody else to treat you.
Infection, obviously, the oxygen is very helpful at minimizing the – and helping reduce the infection. It’s one of the best antibiotics we have. And then again evaluating the other quality of the blood vessels.
So these are – again, the hypoxic tissue benefits to help with the restoration of microcirculation. I think that’s debatable. I think that microcirculation will help, but again, you have to treat the underlying disease. Improving cellular energy by introducing more antibiotic is obvious. Improved tissue oxygenation and improved leukocyte killing ability. So the advantage of hyperbaric or chambered oxygen is still a good part and should be used when needed.
All right, negative pressure is still a very viable option. We can use negative pressure with most of the wound care options that we’re going to talk about. The advantage and to refresh your memory of – is we’re going to be able to remove any of the excess exudate.
And then that suction that’s occurring in the wound is going to help with the neovascularization and the stimulation of granulation tissue.
Obviously, there’s a – we can coordinate and use it with grafts, we can use it with amnion allografts, chorion grafts, we can coordinate it with different wound care products and growth factors.
The downside of most of the use of the negative pressure is if you do get a very beefy granular base, you’ve got to, you know, back away. So you don’t want to get over-granulation and you also want to make sure that you’re managing your wound edges. But it is still a very effective treatment.
There are some newer treatment out there. There are some new dressings that we can use to help advance the wound edge. This particular device we’ve used a few times with good success. This particular adhesive and these little plastic ties, you can advance these ties and you can use it in coordination with whatever your favorite dressing is.
I – you know, we can put an allograft in there, we can put alginate dressing. You can remove these little straps, you can do your debridement, you can reapply. And these we change about once a week. And they’re very well-designed, they don’t get macerated underneath, they’re very easy.
The only downside to these is if you have a plantar wound or a wound in a patient who has a lot of leg edema or you have a lot of maceration, you can have some issues with these sticking. One of the tricks we’ve used is to use some Mastisol or a tincture of benzoin. But very easy to use, helps wound edge.
One of the things that’s interesting about these when you look at the studies is that when you’re pulling these in, the way these adhesives are designed and the way they link in with the straps is they don’t give you any of that tissue ischemia that would’ve been created by retention sutures.
Because that retention sutures, if you use them, create a little tourniquet effect. So these have been very effective. We also use something like this with most of our surgery closures as an alternative to Steri-Strips, and that’s been very effective.
So again, what are the other advanced modalities that we have? And we all started with the Apligrafs and Dermagrafts. There’s the use of tissue growth factors, compression, we’ll talk about, bioengineers, skin substitutes, topical and microbials, placental allografts. And we have some new techniques to talk about near the end of the talk, about autogenous skin options.
So again, the quote at the bottom, despite the advances in understanding the science of wound healing, many of the steps have yet to be discovered and educated. The frontier is still there in reference to being able to create wound healing without hypertrophic, without keloid formation so that we get a good wound healing with good long-term results. We still have lots of progress to make.
So this is a very busy slide, but it does go over all the basics of particular wound care dressings. The bottom line is, and you’re familiar with this, if it’s too wet, you need to dry it; if it’s too dry, it needs to be moist. But there’s – if you look at this particular protocol, this basically covers everything from dry wounds to draining wounds to heavy wounds. And then we talk about macerated edges, other things that we can use to control odor, like charcoal products, we’ve got pain control, tissue growth factors, all of them we’ll get into. And then talking about edema.
Again, as I mentioned earlier in the talk, none of these factors can be overlooked. If you’ve got a wet wound, you need to dry it up a little bit. If you’ve got edema, you’ve got to deal with that. If you’ve got infection – but all of these individual products, whichever one you like the best, whichever works best in your hand, is fine as long you can figure out how to incorporate them together.
And if any of you want this slide or part of the presentation, I can email it to you afterwards, because it is a little busy.
All right, this is understanding how to incorporate biomaterials. So we’ve got lots of different products at our disposal. Obviously, you can figure out how – whether or not you use – want to use collagen products or intestinal bovine products or dehack them, or amnion. Basically, everything you have in reference to the treatment option, these are all – all these tissuing devices, these are all signaling devices.
Essentially, we’re not dealing with live tissue, we’re dealing with signaling devices. You do have some live cells, but again, we’re hoping to influence the wound to heal. We have hydrogel products, cross-linked products to help with wound granulation and stimulation. Again, we’re working together all the different figures to help incorporate the biomaterials into the diabetic wound.
All right, so what can you do? Obviously as we move forward, the most important thing to do is assess the wound and understand the patient and all the different risk factors.
Debride the wound, debride the wound, debride the wound. It doesn’t matter what products we have, we’ve got to make sure that we debride the wound effectively, because without good debridement, nothing’s going to work. We’ve got to stimulate and start that healing cascade. We’ve got to implement preventative measures.
What is going on nutritionally? I mean, one of the simplest things we talked about is talking to the patient about the proper diet. You know, you can be a great surgeon and understand all the wound products, but spend a few extra minutes talking to your patients about what your expectations are for what they’re doing on the nutritional side. You know, if they live on Twinkies and drink diet soda, they’re not going to get better, they’ve got to have good nutrition.
What are you going to do from an offloading perspective? We’ll talk about total contact cast and offloading techniques as well.
And again, choose the appropriate dressing. If it’s too wet, you need to dry it. If it’s too dry, it needs to be a little wet. And then incorporate the biologics and cell therapy so you can stimulate the wound to progress out of the inflammatory phase.
Again, all the different tissue growth factors, there are going to be other talks that get into those, so I won't spend too much time talking about them.
But essentially, remember, these are all signaling devices. These are all to help stimulate the epithelialization, to help stimulate the neovascularization, and to help stimulate the wound to get it out of the inflammatory cycle. And again, they're all great, but they're no substitute to the debridement and managing the underlying disease.
So compression, again, really important. There's some new compression devices that we've had in podiatry, some older ones and then using pneumatic compression. I have – I would love to use pneumatic compression in every diabetic that I have. Unfortunately, getting Medicare to cover it is usually only in those long-term patients with chronic venous insufficiency who failed conservative care. But if you use a good compression dressing, or you can get your hands on pneumatic compression, you will find that those diabetic wounds will heal in a very, very short period of time.
The diabetics that we've used pneumatic compression on, even with the biologics that had failed previous, we've healed diabetic wounds in 2, 3, or 4 weeks where we would have failed because we've gone ahead and then dressed the underlying compression. When you use pneumatic compression, you're squeezing the wound. You're getting rid of the edema. That allows the arterial to flow, to get in and that helps get rid of that fluid in the interstitial space. So if you have a diabetic wound and you want a – getting that access to pneumatic compression, feel free to do so because it will help you. And then, if you don't have access to it, there is some really great products out there as well.
There's a big role for total contact cast. I've given a number of lectures over the years for 3M on total contact cast. I was not a fan of total contact cast when I was in a wound care center. The reason being is most of the total contact cast that we had accessible to us were very rigid. The 3M product of total contact cast is a flexible device. So you get that pumping that we talked about and you get good offloading. We've had really great success with total contact cast and it really helps implore patient compliance.
So if you have a patient who is not healing, you've addressed the infection, doing good debridement, you've got a good wound product and you're not getting somewhere and the compliance might be an issue, go to that total contact cast.
All right. So again, sort of read back to the bioengineer products. We all started with Dermagraft and Apligraf. Those products are still out there. They're still viable that, you know, being able to stimulate the wound in the collagen matrix. They all work pretty well. They're still viable options.
So all of the amnion, chorion, I've given many lectures over the years on using placental allografts. Again, I don't care which one you choose. They're all signaling devices. I tend to use – I've gotten away from using the dried – freeze-dried stuff. More of the cryo-preserved or fresh for my wounds. We've done some cases where we've injected the allograft underneath. That's been very helpful. We've done debridement underneath the ulcer with Tenex and then incorporated the allografts.
Again, the key with allografts is debridement and managing the comorbidities. Although these are really great devices and they have anti-scaring and antifibrotic and anti-inflammatory and antimicrobial, they have great properties. But again, they're no substitute to the good debridement, the good offloading, and managing the patient as a whole.
All right. So again, this is – you're familiar with this. There's lectures on all of how these all work. There's some new advantages out there. So there's some new companies out there, two that I can think of that show or may nameless, that are harvesting patient either in ellipse or a punch biopsy and then we send these away to the companies. And usually, within about 24 to 48 hours, we have a skin product back that when it regenerates, the wound will regenerate, the wound with the entire epidermis, dermis, and glands, and pigment, and hair follicles which we've not seen before.
Now, this is very new. We don't have a lot of experience. We've done a couple of cases. But it's indicated in the repair of the diabetic foot or chronic venous insufficiency. It can be used in trauma cases, surgical reconstructions. It's indicated for burns, scar revision. I think that the advent of this is going to be very exciting.
A little bit of background. Basically, the way it's done – and this was a company that was developed by a plastic surgeon, so they sort of indicate that maybe a small in the lower extremity a 2x1 ellipse. So 2 centimeter long by 1 centimeter ellipse. The ones that I've done underneath the – I'll show you where we did it, underneath the fibrillators, a nice little fatty pouch there. You're going to prepare, you send that in, and then, within about 48 hours, you get back a syringe with the tissue product in it and you basically just squirt it onto your wound and then you cover it with a silicone barrier and then do your offloading and your addressing. And then, you're going to leave that silicone barrier in place for about 2 to 3 weeks. We check the patient back at 1 week and 2 weeks to make sure that the offloading is there and they're being compliant.
So this is some of – I'll show you some of my cases next. But this is an example. I apologize for the quality of this image. But this is a patient who's an older gentleman, had a significant medical history with aortic aneurysm and had a – there's a nasty wound that is – as you know, the lateral foot is a very, very difficult place to heal. This patient had failed with skin graft and had a – one of these products supplied.
This shows you a punch biopsy of what the skin looks like after. So that even though you – they got this guy to heal, they took a punch biopsy and you can see the normal epithelial and dermal structures here with already rigid.
So you've got somebody who's not just healing the wound but regenerating normal skin structure which is very, very important advent in this particular technology.
So if you see here, this is one of our cases. This is an elderly diabetic. Really nice guy. He's had multiple ulcers that have not healed. This particular one on the hallux. He's had biologics. He's had offloading. He said, "You name it." He's had it. No underlying osteo. This is not a particularly huge ulcer to treat, but he was amenable to give it a try.
So we – what I did was we took a small biopsy from – on a lateral inferior to the mallet. This is an area. We take a little biopsy from here and then we close it primarily and then, we send that ellipse away. And then, they send us back the syringe with the product.
The good news is, moving forward, the company has developed a way of – so that you won't have to do the ellipse anymore. You'll just do a couple of punch biopsies, a couple of 3 millimeter punch biopsies and you'll place them in the same liquid and you'll get back the tissue that you need which is going to be very exciting, I think, for – in the foot and ankle space.
So this is what it looks like at about a week later. We did some offloading, special shoe and this is just basically a silicone barrier. And this is what it looked like at 2 weeks. So we don't know yet, you know, with the long-term because this is relatively new to us. We don't know what the long-term results of this are going to be, but very, very promising.
It what's interesting that the patient who is pretty much neuropathic, it's a long-standing diabetic, was telling my associate and I that he – once we put the skin product on, within a few days, he started having sensation in that part of his toe which he had not felt before, so it's very interesting. And he was still reporting that out 2 weeks ago. He says, “Doc,” he says, “I don't know what's going on, but I can feel something going on in my toe.”
So we talked to the company and the rep who came and they – he said that that's not uncommon. They have experienced that. So I'm not quite sure what's going on yet. But it'll be very exciting to be able to provide patients with their own genetically, you know, identical tissue to use for their repair.
So in summary, remember, the key to excellent wound care is the proper evaluation of the patient, all the risk factors, you know, the arterial, the venous, the nutritional, personal factors, whatever is going on. And we need to address those because when – in not doing so, we won't be able to get them to heal no matter what we do. There is no substitute to good wound debridement. These are all great products that we have at our disposal. But you have to debride in order to get rid of the bioburden and stimulate that healing cascade.
Again, wound care is not complicated. If it's too dry, it needs to be not too wet. You just got to find that sweet spot. The bioengineering placental products that we have at our disposal, but again, there are no substitute to the steps 1 through 3.
Hyperbaric oxygen and topical oxygen chambers for the lower extremity are very helpful. The key is if you're going to use them, make sure that you're going to figure out the most cost-effective treatment for your patient. I think the use of hyperbaric chambers, you know, are still effective. But I think when you look at the cost, we have to figure out what technology that we can use and do it as efficiently as possible.
The new advances to regenerate the own patient's tissue, that's that last couple – the case I showed you, I think it's very interesting. I think there's more research that needs to be done. I hope to be able to come back to you at another meeting or maybe this time next year and tell you, you know, how it worked out and what those advantages are to us and how we're doing.
So I wanted to thank you for your time. And if you have questions, I have a few seconds left or I'll be here all weekend.
All right. Well, thank you very much for your attention. Have a wonderful weekend.
TAPE ENDS - [30:03]