Thomas Serena, FACS, MD reviews the types of surgical and non-surgical debridement available. Dr Serena discusses the literature describing the wide range of benefits in the use of enzymatic therapy with collagenase both with and without surgery.
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Release Date: 03/16/2018 Expiration Date: 12/31/2018
Thomas Serena, MD
Vice President - American College of Hyperbaric Medicine
Founder & Medical Director, Penn North Centers For Advanced Wound Care, Erie, PA
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Thomas Serena has disclosed to be a consultant/advisor and/or a clinical trial investigator for Arthrocare, Celleration, Circ-Med, CoDa, Cytomedix, EnzySurge, Health Point, Kaypto, Mego Aflec/Lympha Press USA, Molnlycke Health Care, MoMelan, Osnovation, PolyRemedy Inc.,RedDress, Sanofi-Aventis, Systagenics and Tissue Therapeutics
Male Speaker: Next speaker has returned for another return engagement here, speaking about biofilm reduction, wound bed preparation and management from the [Indecipherable] [00:12] at the early stages for wound repair. We’ve asked Dr. Tom Serena to come and speak to us on Enzymatic Debridement, the indications and clinical applications. Many of us do use enzymatic debridement. I think the question remains when do we need it, when do we not need it, when do we need to stop with it and what are the benefits of it. So Tom Serena has been with us several times in the past. Dr. Serena is director of a nationwide wound healing group. He is a trained vascular surgeon who now specializes exclusively in a wound care and is consultant for a number of companies. I just learned I guess last week that Dr. Serena moved from somewhere in Backwoods, Pennsylvania. He is now moved up to the Republic of Cambridge in Massachusetts. So let’s welcome Dr. Tom Serena to the panel.
Dr. Tom Serena: Well thank you. It is really a pleasure to be here again and I have couple introductory slides that it goes through quickly. I consider myself a vulnologist now and I learned from Marco Romanelli who is that – and this is the term I should be – I was using woundologist. I guess that’s the inappropriate term based on the Latin derivation. I’m looking for something to call ourselves. I think we may have a name and that seems to fit with me somehow. We have centers all over the place as Bob already mentioned. One thing I’m going to give a shout out too since I’m here is the Wound Healing Cooperative Group. If you are interested in doing research and we just started a great research lecture, prior to mine. And I’m going to talk about some of the researches been done as well then you may be interested in joining our cooperative group at nation’s first. And hopefully one of the many cooperative groups in wound healing where they have a large nerve centers that worked together to do research. So first how do we influence the macro environment and for that matter the micro environment of the wound. The main tenant is the use of debridement and of course control bacterial burden that used of a moist wound healing environment and the offloading or compression therapy. And I’m going to focus today primarily on debridement. I’m a surgeon. I like to cut things and we used to say in residency that if you can’t cut, you can’t cure. Usually I said this is the end of an argument with an internist and so let you know that may not really be the case and then may not be appropriate for us to be wielding our scalpel on every single patient. And there are certainly indications where other types of debridement maybe applicable. Just a brief review sharp debridement is to remove all these tissues, removes enzymes or cells at the edge of the wound that aren’t really – they’re there but they’re not really functional cells. They can be removed with sharp debridement. And every patient’s going to be able to have sharp debridement. And certainly this patient who has infantile segmental hemangioma is not going to die – I don’t know if anybody in the audience who would take a blade to that. In this case, we actually use a product very similar to what was already mentioned in the last lecture non-contact thermal ultrasound, a low frequency ultrasound and it had a very nice result. And this is the patient who obviously has a neurologic problem in the lower extremity but also has an ischemic ulceration. There’s very low blood flow and when you do laser Doppler and get a skin profusion, it’s very low. So this is another patient that you or really, are you going to wield the scalpel to this lesion. And I think by the end of this, the answer is really no. Just looking at different types of debridement, there’s a mechanical debridement. Wet to dry dressings which I hope no one is still doing. If you are considering doing wet to dry dressings, I think you should realize that Centers for Medicare Services now considers that a negative quality indicator. So at the end of this year if you’ll be using wet to dry dressings, it’s your hospital. And Medicare is going to publish that and so we public information, so you can go over and look at your neighbor’s hospitals anytime they use wet to dry dressings and then call your local paper and see if they can publish how terrible wound doctors they are. Ultrasound in other way do mechanical – a sharp, been already mentioned biosurgical, we have certainly used maggot debridement therapy in the past continued to use it day to day.
We’ve even tried maggot debridement therapy in combination with hyperbaric and the little guy is like the oxygen a lot. Autolytic, you can put occlusive dressing on with the body on autolytic enzymes dissolve the tissue. Not something I’m used very often at all. I don’t have a lot of experience with autolytic debridement and then enzymatic debridement, we’ve been obviously it has been around for a while. And I will tell you that we’ve used collagenase by the bucket load over the years. So in this slide that I stole from our next speaker, Greg Schultz, looking at different ways to think about debridement. If you look at a wound environment, there’s sort of microscopic debridement which is episodic. And it’s really sharp surgical debridement. In this case, the first time you see the patient you come in and you’re going to debride the patient but then subsequently the patient may develop a slough – they feels the wound that maybe do the underlying biofilm. The slough is not the biofilm, I want to be clear about that. But there may be an ongoing need to reduce that bio burden and it maybe a bio burden that’s – not even a macroscopic maybe microscopic. And I think this is really where the role enzymatic debridement comes in. Looking at the mechanism of how collagenase works, well there is only one FDA approved enzymatic debridement agent in the market. It is the collagenase product. If you look at the wound, necrotic tissue is held in place with these little strands of collagen. And so if you really want to break off this necrotic tissue and get it easily come out of the wound or in an ongoing basis, the patient puts this on a daily basis. Then we can just cut those little strands and make necrotic material come off and that’s really how collagenase works. It’s really rather simple. Is there evidence for this? In actuality, there is actually really very good evidence for the use of collagenase in chronic wounds. And this has been gathering evidence over a number of years. Now before I talk specifically about the evidence, I wanted to just back up a little bit and talk about end points. FDA for approval of products says that the end point that we must use in wound healing clinical trials is complete wound closure. Well I don’t use collagenase products. I use a scalpel for complete wound closure. We use collagenase to help us get from an inflammatory wound where a lot of necrotic material to one that has a nice clean granular base. And maybe I’m going to use some other advanced therapy to get that wound to eventually go to closure. So a lot of the studies that have been done with these types of agents have been fairly small and not done for PMA or IND for drug therapy. And that’s really because of the end points that we have been sort of handcuffed into using. This is one of the studies looking at ulcerations debrided with collagenase versus the hydrogel. Now the reason I showed this slide, the reason I showed it first is because I commonly go to wound clinics and I visited a lot of wound clinics and watch out doctors doing what they’re doing. And I find that people kind of move away from collagenase onto hydrogels and I don’t know why. I mean it’s just something maybe the hydrogel people are buying more pizzas, I don’t really know. So we’ve include this from the general wounds in which the collagenase was compared directly to a common hydrogel. And you can see that from the quality debridement and the rapidity of debridement that collagenase is much more effective. Looking at fresh ulcer debridement in a group of pressures, ulcer patients treated with a topical collagenase versus a placebo. The placebo is basically the collagenase vehicle without the collagenase in it. And you can see that and when you look at this and I’m sorry other part of the slide must be – that’s the quality of debridement on the – it is not on the picture. And that’s 84% of improved debridement in those 28 patients who were treated with collagenase versus the vehicle which doesn’t worked very well at all for a debridement which makes a lot of sense. Diabetic neuropathic ulcers developments they studied, looked at 30 patients who received collagenase as a wound debridement agent. And they found that the majority of patients had very good results 20 to 30 patients and then six of those patients had a good result. And only one patient had a fair result and they lost three patients in the study in a 10 to 3 population.
So you can see that both pressure ulcerations and a variety of different ulcerations you can use collagenase. It’s a basic mechanism of how necrotic material sticks to any type of chronic wound. Another study I think is important to realize and I do see some of the centers doing this combining collagenase with Polysporin ointment and this is actually where that information comes from. It was a burn study and if you look at this, it’s a very large burn study actually. It is a randomized controlled trial comparing collagenase with Polysporin to what we use in the burn centers primarily which is 1% silvadene or silver sulfadiazine which is a very high dose silver about 3,000 parts per million. And if you look at the comparison you see that almost half of the patients in the collagenase Polysporin group had debridement. The main thing about this study is that they chose patients that had burns areas at notching areas. Actually the patient was their own control. And these are really terrific studies. Because you can do inter, within the patient analysis and so when you do the interpatient analysis I compare patient X, the collagenase Polysporin wound to the silvadene wound. That way each patient serves a control. And what we found is that that you really have a much improvement and rapidity towards getting a nice, clean granular base something that can go to an advanced therapy. It was also more rapid and the debridement seven days in the collagenase combined with Polysporin, and nine days in the silvadene group. So when you combined all these, you see that preparations containing the collagenase having shown the effect on the soft tissue. And pressure ulcers, venoustasis, ischemic arterial ulcers, neuropathic, diabetic foot ulcers and burns. That’s really a platter of clinical evidence that supports the use of collagenase in our chronic wound clinics. So it just gives us another bullet in our armamentarium in which to treat chronic wounds as well as scalpels which is hard for surgeons to say. So in my expert opinion and again this is just my opinion, I like to use the after sharp debridement. You do debridement, you get down to some tissue that’s not really bleeding, puncta bleeding and lots of times that’s where I’m going to use collagenase to do a slow ongoing debridement. I really like to use a lot mixed ulcers particularly venous ulcers that have a poor arterial inflow. I think that it’s really been a mainstay for us there. There may be situations where sharp debridement is not feasible nor we said midlevel practitioners in our nursing homes and really don’t want them doing some of the debridement, so we do it in a clinic in a nursing home where we have a less controlled situation. In this case, collagenase can be very valuable. And in vasculitic ulcers; in patients with poor arterial supply or patients with a vasculitis, those are the two patients you don’t want a sharp debridement on. For arterial ulcer, you don’t want to do a sharp debridement because as you debride using a sharp blade, you can increase the metabolic demand of that tissue after you debrided it. So it needs more oxygen, needs more nutrient oxygen but if they have an arterial ulcer they can’t provide that nutrient oxygen. So what happens when and classically when someone debride an ischemic ulcer, it’s one square centimeter and then next we pick him after debridement and it’s two or three square centimeters in size. And the same thing is true vasculitic ulcers and I firstly made this mistake more than once where you debride an ulcer doesn’t look like a vasculitic ulcer or pyoderma, and the patient may not even have the right historical information to say that it is pyoderma. But you debride it and they come back the next week and the wound is 50-100% worst and sometimes I made the diagnosis of vasculitis that way. And that’s the smartest way to do things but it is the way it is. So just to share with you in my last few minutes, some examples, so here’s a patient where we’re using collagenase on. You can see it doesn’t project quite as well as it is in my laptop. But there’s some granulation tissue on half of the wound. I picked this, we debrided it once already. It’s a surgical wound and we’re now treating the patient daily with collagenase to degranulate. This is a patient who we seemed crosshatched this and we’re using collagenase on the wound in an ischemic or vasculitic ulceration. And this is the patient you’re not going to do you just can’t go and take all that tissue out simply because it’ll get worst. A venous like ulcerations that developed a lot of slough week after week, one of the treatment regimens we have been using in this is to use collagenase. Put it on about thickness of a dime, that’s not collagenase on the edge. That’s just zinc oxide with a nurse in the center really loves zinc oxide.
I want you to think we’re burning the patient’s skin. And then this is pyoderma again where there’s no that when – I like this slide because it shows all three stages of pyoderma that one time there’s tender nodules. Then they progressed to a blue edge and they end up in necrotic ulceration. And sometimes when you see particularly in the lower extremities you just see the necrotic ulceration and maybe some has underlying venous disease as well. Venous disease is very common and you go debriding and then next they come in and now they’ve got the blue margin and now the ulceration is considerably worst. And this is the patient where collagenase has really become our mainstay in debriding these ulcerations and getting them ready to do other advance therapies along with of course anti-inflammatory, antibiotics and steroids. So here’s another patient with a very complex wounds, we just certainly not going to – this is a patient with multiple venous leg ulcerations. This slide is actually taken after we’ve been using the collagenase for quite a while now. We’ve actually been using for about two weeks and you can see along with the compression that she was applying at home. And you can see we’ve cleaned up very nicely but this is a patient that has just a terrible problem with sloughing and extensive exudate. And I think this is another indication where combining collagenase used with surgical debridement. In this case compression really is another tool that we can use to take us down to complete – to get these patients from the inflammatory phase of wound healing into the proliferative phase in wound healing. Get them moving forward towards closure. And I’m going to end with that as I told Bob I will get done and save a little time here at the end. I want to thank you and now I’ll take any questions afterwards in the panel discussion. Thanks.