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Thomas Serena has disclosed to be a consultant/advisor for Smith and Nephew, MolecuLight, Organogenesis, Mego Aflec/lympha Press USA, Molnlycke Health Care, Rogers Sciences, Integra, RedDress, Cardiovascular Biotherapeutics and Tissue Therapeutics.
Male Speaker: Now we have another vascular surgeon turned wound care specialist, Dr. Tom Serena, who many of you may have known from previous present meetings. Tom is very instrumental in working on key new technologies with the wound care arena and he runs several wound care centers in – I thought it was New England, Pennsylvania but I think they’re all over. Tom used to be in Pennsylvania. He’s now moved up to Cambridge, Massachusetts. He always has something interesting to say. So one of the key components of wound care wound bed preparation is the use of wound cleansing agents or antiseptics. So Tom is going to give us his insights now on antiseptics and more importantly what are safe antiseptics to use as a wound cleanser. So let’s welcome Dr. Tom Serena.
Dr. Thomas Serena: All right. Thank you very much. I just coined the term safe antiseptics really for – it just sounds better than wound cleansers to me. I think that’s more the way they function. So Bob has already mentioned that I am a vulnologist as our Italian colleagues have now told us when Bob and I were at Milan last month. They started using the term vulnologist to me, the wound care specialist or woundologist. I guess we’re going to have to go with that. If you want to know what I do and what I am involved in, this video is off of our website. I may not play the whole thing. Yeah, I may play the whole thing. But it just goes through what this really group is. I get a lot of questions on that. Like so many of you in the room, we are involved in everything that’s got wound care throughout the United States, through the work that we do in a number of different countries and now the sound is on. So I’ll let you finish this. It’s only 47 seconds long so there’s not much left. There’s a couple of mistakes in it too. You got a bonus if you could find the mistakes. All right, thank you. So one of the other things that it has nothing to do with my talk today but has to do with what we’re working on. Finally, after years and years of working, a number of the thought leaders have gotten together and formed the first cooperative group of wound care where we have centers that cooperate in doing research. If there’s something you’re interested in, please let me have your – give me your contact information and we’ll see if we can get you involved in that. I’d like to start off with a clinical trial that Marty Robson and I did in the year 2000 with KGF 2 for venous leg ulceration and you didn’t hear Chuck talking about that a minute ago because it doesn’t work and it was never approved. But we did learn something from this very expensive and extensive trial. That was we took patients of venous leg ulcerations and investigators had to look at the wound and say the wounds were not infected. Then we biopsy the wounds. And then we could tell how accurate the clinical examination was as opposed to what a quantitative tissue culture biopsy which in 2000 was the best we had to determine if the wound was actually infected. We did this in quantitative analysis. What we found was interesting. We screened 614 patients enrolled, 350. And if you look at the just the screened patients, there was about a 20% incidence were that investigators said the wound was not infected and indeed it was infected with greater than ten six organisms. If you take the patients that were enrolled, that number goes to 25%. In subsequent clinical trials we’ve repeated this and the numbers are almost exactly the same and the present clinical trials, the number ended up being about 26%. So the accuracy of your clinical exam at least in venous leg ulcers for the presence of bacteria in the wound bed is about 75%. We did some studies with the acceleration in pressure ulcers that show it’s much worse in pressure ulcers and maybe slightly better in diabetic ulcers. So in chronic wounds the classic science and symptom of infections are not reliable. If you’re experienced, you tend to undertreat patients for wound bed infection. I’m not talking about cellulitis. I’m only talking about the wound bed itself has too much bacteria. We know that the inexperienced over treat and everybody who runs a wound care center knows that every time you walk in to a – every patient that walks in through your door is on antibiotics for a venous disease. It doesn’t matter what they come in for. They’re on antibiotic just for having the wound. So what do we do? What’s the solution? And solution really has been a topical antiseptics. They fell out of favor because at one point – and I remember doing this, putting Betadine on wounds, full strength Betadine on wounds. It’s been for a long way since then.
Probably the most common antimicrobial we’re using is silver. Silver is used as an antiseptic from oysters to outer space. It was initially credited for being developed in Persia where King Cyrus would put silver coins in the water supply and found that his population was healthier. Silver kills everything. I mean it’s been known to pretty much kill any – even the superbugs are destroyed. Allergic reactions occur in less than one percent of patients. Resistance is extraordinarily rare and the only cases of resistance have been found in silver in used in very large amounts. The reason the silver kills so effectively is because it has so many different actions. There’s eight different actions of silver on bacteria. It attaches to cell wall. It attaches to intercellular organelles. It attaches to nuclear materials. So it really has so many mechanisms of action that resistance has been very rare. [Mersa Carter] [05:56] has done a nice review of the publications to date on silver and you can see that most of them show some benefit in bacterial reduction. A couple have actually showed some benefit in complete healing and some reduction in wound area. We’ve been doing some research with a company called NZ Surg and now [Angelini] [06:18] distributing in the US with a product has a silver solution. So you can see it has the silver in the solution but it also contains some glycerol and some other components such as tween. This has a huge advantage and that it causes – it has an anti-inflammatory effect. The glycerol also keeps the wound from getting too – if used a lot, keeps the wound from getting too macerated. I’ve included the next two slides. It’s just on the benefits so you have this information. I’m not gonna simply read these slides but you can see that the addition of these other materials has two-fold clinical – we see clinically. At first is that you don’t see maceration and the second is that it seems to decrease pain when the patients are treated. This is just continued and this will be included now in the slide set. You have this for your review. We’ve done a number of in-vitro data looking at bacteria and reduction with the use of this topical silver product or safe antiseptic. It kills everything just a dead as the other silvers do. With our safety and efficacy study in a couple of our clinics and found that – I’ll share you a couple of examples in a minute. Really there’s a nice job of removing that slough, particularly venous leg ulcers we just see week to week. We were able to demonstrate that it was safe. We had virtually no reactions to it and had very, very few adverse events. A couple of patients there’s some burning and things of that nature but really was minor. And then again this is just the same version of that. It will be included for your notes. I’m not going to read the slide. This is one of our patients. What you can see is that the patient was treated, the venous leg ulcer. We used it twice a week under compression. You can see that one patient was treated with the silver. One leg was treated with the silver and the other was not treated with the silver. You can see that slough that you see very commonly in venous leg ulcers. We were able to eliminate that and keep it out of there. I don’t know the mechanism of this. I have a theory behind it although I can’t really prove it. This is a patient with a fistula and we’re just trying to clean up the fistula and get it. By controlling the actual burden, we really were able to stabilize the wound and really make it a much easier wound to treat. Here’s a diabetic foot ulcer. Again, reducing bio burden on it. It doesn’t take it to complete closure. That’s actually not the goal of antiseptic. You’re not using antiseptics to take wounds to complete closure. We’re using it to get the wound a proper bacteria balance. So what is the possibility, what is the other possibility? It stopped playing. I stole that from Greg Schultz. One of the other possibilities for the SilverStream was the fact – maybe reducing bio burden and that’s a slide of Arnold Schwarzenegger shoots the guy. He falls to pieces on the floor then he starts reforming. That’s the problem with biofilms. They reform. I think what we’ve seen now in illustrating two studies is that we were able to eliminate biofilms in venous leg ulcerations. I’ll go to the next slide here. This one is from the University of Montana where we look at pseudomonas aeruginosa and staph aureus and MRSA. What we were able to find is that with this SilverStream applied with some minimal pressure, that we were able to reduce biofilms. Greg Schultz and his team has repeated this in a study in pigs. We were part of that and we hope we have managed to get that submitted for publication now. Demonstrating that in vivo, we were able, at least in pigs, we were able to demonstrate that we could reduce biofilms by administrating this silver solution.
And it’s just the patient again. We were trying to figure out. Look at that slough and say that’s a biofilm. That’s not a biofilm. You can’t see a biofilm. But there are some folks that believe that when you build that slough it’s because there’s an underlying biofilm. That’s been improving to my satisfaction. However, when you see with this kind of change in a patient with a wound and you have to wonder if reducing that slough or reducing the biofilm isn’t the cause. This is another one of our publications that we’ve presented last year. Just demonstrating the same thing. We’re able to reduce slough in these patients and so it makes their care a little easier. The other antiseptic we’re working on, the other safe antiseptic we’re working with is sodium hypochlorite. I call it pool water. I apologize to Angelini folks for renaming their product but it smells like pool water. The patients actually like it. It has a clean smell. They’re very much in favor of using this. It is also a germicide. It has a wide spectrum of activity against pretty much all microorganisms. Kills everything dead just like silver does. It’s nontoxic and for the most part if you use silver for about 28 to 30 days, it’s nontoxic. But hypochlorous acid or sodium hypochlorite is a very nontoxic safe antiseptic and there isn’t really any residual of breakdown products. Why is sodium hypochlorite a nontoxic? Well it’s because that’s how neutrophils kills. This is a neutrophil and those are red blood cells. He’s chasing these bacteria in the other slide. We call this the PMN chase. He or she is going to chase this bacterium around and eventually it’s engulfed. They kill bacterium through either superoxide radicals or through hypochlorous acid mechanism. This is one because we’re teaching residents that I thought we’d ask them one trivia question. Bob probably knows this. What animal does not have neutrophils? There’s actually one animal that gets into all kinds of trouble and this is actually [Rob Kerzner] [12:18] and I down at a water park examining the animal. If you’re really great at the medical trivia pursuit, then you know that it’s a rockhopper penguin. They get the diabetic-like ulcer in their feet, the webs in their feet. You can see it, they’re big and swollen. You really can’t do much about it because they don’t have neutrophil function. It’s an oddity of nature. So this is some of the patients. We have actually a contest going on in the clinic right now with case studies and we have all of our clinics. As Bob mentioned, we have a large number of them that go from coast to coast. We’ve introduced the sodium hypochlorite to a number of the clinics and they are testing them, taking a lot of pictures. We’re using it as a safe antiseptic when the patient’s undressed, we clean off the wound with the sodium hypochlorite and then we usually let it in contact with the wound for several minutes. That’s vary between two and five minutes based on what the study coordinators and nurses have been doing in the clinics. This gentleman has a wound. It actually was healing up pretty nicely but has this tunnel. It’s not osteo but it is a tunneling wound and rather problematic at that point. This is initial presentation two weeks of just cleaning the wound daily with the hypochlorous acid which we were able to really get that closing very nicely. It’s still there. You can see there’s a little goo there and there’s still a little ulcer underneath that but for the most part it’s closed up very nicely. I’m really very, very impressed with the result. I think the only reason for this result is you’re just decreasing bacterial burden. That is one of the basic tenets of wound care is to decrease the bacterial burden within the wound itself. Here’s a patient who is receiving hyperbaric oxygen therapy and really not progressing very well. I think if you’ve read the recent [Margolus] [14:08] paper, you can see that if you forget about doing good basic wound care and you put a patient hyperbaric and say, “Hey, this is magic,” and it is a magic bullet. Everybody put in the chamber is going to be magically achieve closure. I think what we saw from that study was that is not the case. So you have to continue good wound care. We need to do multimodality therapy. We need to combine therapies with this rather expensive hyperbaric modality. I think if you’re using that approach, you’re going to get good results. Certainly we saw four clinical trials which showed efficacy for hyperbaric and now one that does not show effectiveness. That means that somewhere in the general practice of medicine we’re not doing the right thing. I think this is a good case that demonstrates that. This is a patient. He was being treated with hyperbaric at about two weeks already. Wound is not getting better. We started cleansing the wound daily with sodium hypochlorite. It had a very rapid response. So this is what it looked like a week later or eight days later.
This is eight days later. You can see that wounds really responded nicely. At this point, actually this is the day we did the grafting. So this is multimodality therapy. We cleanse the wound with sodium hypochlorite for a period of eight days, cleaned it up very nicely. It had a very nice response. He’s receiving hyperbaric therapy. Actually the next step in his care was to use a new product just purchased by KCI called Cellutome. That is a skin grafting device that you were able to do at the bedside painlessly and you put a little device. I’m not going to talk about it here. It’s not the venue for it. But you put a little device on the patient’s thigh and you can take epidermal blister grafts and then transfer them on. So you received the hypochlorous acid as a preparation to get us to this point. Hyperbaric oxygen therapy and the skin grafting, a nice multimodality therapy. They got a very poorly controlled diabetic who’s had multiple amputations in the past. He had chosen the other foot to come to complete closure. So what are recommendations for safe antiseptics for venous leg ulcers? We cleanse the wound with one of the safe antiseptics at each weekly dressing change. More and more got in a habit of bringing our venous leg ulcer patients in the beginning a couple of times a week. It’s not the most advantageous from a financial standpoint but it does make good stents clinically. Jim Wilcox has published a recent paper demonstrating that if you do that, you do get a little better healing times that way. So our routine is we cleanse the wound weekly or biweekly or twice a week for the first couple of weeks. We leave the antiseptic in contact with the wound. We usually soak up a gauze and we lay it on there. “Hey, Mr. Jones, we’ll see you in a minute.” We leave it in contact. That seems to work better than just sort of putting it on the wound, splashing the pool water around and running away. We’ve done this both with this. We applied it both. The SilverStream which is a silver and both the sodium hypochlorite. For diabetic foot ulcers, we’ve been giving this to the patients. They’re doing it themselves. After initial debridement, usually early on in presentation, they’re doing the dressings, wet to wet on a daily basis. It just takes a little more education but we do that for about two to four weeks. If I’m worried about wound bed – a high wound bed colonization, we’ve been using the SilverStream. But you can easily substitute it with sodium hypochlorite. If you’re a Vosh fan, the sodium hypochlorite is very similar to that. We virtually replaced out Vosh with sodium hypochlorite at this point in our centers. For pressure ulcerations, it really depends on the treatment. We’re starting to play now with the infusion. I know many of you have seen the KCI’s version of the infusion pump, a negative pressure pump. There’s this Fed version that’s continuous. I think we add these five safe antiseptics in those kinds of devices that you’re going to see better results. The data from the University of Miami and the data from the University of Florida demonstrating that when you apply some pressure and administer the SilverStream, you get reduction of biofilms may explain it. I’m underlying may but I think we’re gaining some at least preclinical evidence to suggest that the administration of these antiseptics under some pressure is decreasing biofilms and maybe assisting in getting these wounds closed, reducing the bacterial burden. Not just the planktonic bacteria but the biofilm bacteria as well certainly the pressure ulcerations from the studies that we’ve done really have a lot of biofilms. We have a large number of high level of bacterial burden and that makes sense based on their location. So we’re treating those either on a daily basis or based on the regiment if you’re using negative pressure. It might be three times a week or if you’re using it still then it’s pretty much every day. And then arterial ulcers, obviously as a vascular surgeon, arterial ulcers need to be revascularized. It’s my opinion. But occasionally we send someone over to the endovascular folks or the vascular surgeons and they come back without any holes. So those patients we can do some gentle sort of debridement with the – see if we can debride those ulcers and see if we can keep maintaining the lower extremity for as long as we possibly can. I’m going to end there. Thank you very much for allowing me to joining in Super Bones again. Thanks, Bob.