Regenerative Healing: Insights on Wound Microbiology, Scar Reduction, and Biologics

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He is absolutely fascinating in parts in how he breaks down how wounds function at a cellular basis. And I think it's a great podcast for viewers in general, but specifically for those who are more interested in the microbiology of wound care. But, I think Dr. Starinski is a fantastic guest and I hope that you enjoy this episode on the Open Wound Research Podcast.

Thank you.

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I think you're going to add a lot of value and share some of the great stories that you've told me in passing.

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University in Pennsylvania.

In the Poconos region for any Pennsylvanians watching the podcast. He also received a master's degree in biology from East Stroudsburg University as well. He then moved on and received his doctorate in podiatric medicine from Temple University in Philadelphia, also in Pennsylvania. at which point he traversed across the country.

Did his residency at the Tucson Veterans Medical Center. Administration medical center in Arizona. he has participated in numerous international wound care medical missions, which we'll come back to a little bit later. And he's also presented and published on wound care research, especially around the subject of biologics.

He has a long history of, medical and educational directorships in the realm of research and clinical development. So with that massive mouthful, welcome here again. And, I, you know, what's really interesting is to me, at least is the breadth of your education, um, and what you sort of your pre story to wound care.

Maybe just to get started, one thing that caught my eye was geography in undergrad. What was that about?

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So it was kind of my mission in life to do that and, uh, kind of worked out the way I planned it.

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I, uh, didn't, you know, didn't really have the time because I was, uh, I switched over to the, uh, college in, uh, in Temple to finish, to go for the, cause we had a cooperative program with Temple, um, at East Stroudsburg. And, uh, before I could finish out a full degree, the minor was, uh, it was enough, uh, for me. I did teach chemistry a bit in a community college though.

So that was, uh, That was kind of fun. I'm particularly attracted to organic chemistry.

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So, uh, BSU has a strong science pro uh, program and the master's there was, uh, was good. It was challenging and it was, uh, it was, it was fun. I mean, I remember writing the thesis and. All the rewrites I had to do was, uh, agonizing, but, uh, got through it.

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So, uh, we have, I have a very interesting history with East Stroudsburg because my most memorable moment was getting into a fight on a rugby field.

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Uh, it was fun. We, we, we got into a fight, but we made up and we recovered the way rugby players, players recover with a party and, uh, so yeah, so it was brilliant.

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I think it's the most fun sport to watch because the action never stops. Yep.

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Uh, I mean, a lot of my colleagues and I'm involved with the, uh, Chicago Lower Extremity Surgical Foundation and the, uh, um, microsurgical group. Um, you know, routinely now podiatrists are doing reverse muscle flaps, uh, you know, taught to us by plastics and, uh, uh, we've come a long way and that helps with the treatment with the, with the wound care side of the practice, which really is interesting because every patient is different, which, which makes that.

Part of the practice. Very interesting. The routine part of podiatry, the, uh, you know, bunion surgery and all that was, uh, was fun, but then there's only so many bunions you could do before it gets pretty boring, whereas the, you know, whereas the Charcot reconstruction site was much more interesting.

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The Charcot seems to be a point of, uh, deep interest in the podiatric community. Uh, anytime I go to podiatric conference, Charcot's first and foremost, Uh, and Dr. Charcot's work. Uh, before I, uh, started hanging out with, uh, you rowdy podiatrists, uh, did not know much about the Charcot foot.

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Uh, you're not doing it for, for the financial, uh, reward. You're really doing it for the, you know, for the love of the work. And that's kind of why I like that part of the practice.

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I mean that, that is a challenging setting to work in.

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Uh, I remember I had best story I have on that is that a patient, uh, an oil worker, uh, with a diabetic wound that I was treating, um, you do a surgical excision, uh, and then you follow up with treatment and you hope that they're compliant. But every time I, I saw him, I'm like, And you have a long drive and one day he said to me, you know what, doc, it's not a bad drive.

Midland and back is just a two, six pack drive.

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So, um, You know, having a, this company in particular has a, is, you know, veteran owned. So, um, you know, have a soft spot in my heart, obviously for the vets. And I think getting them involved in the, in research is, is valuable. Uh, it's, and having a research group, um, as each of these, um, veteran visions have, um, is, is pretty impressive as well because they have the, they have the staffing to help the research go forward.

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Contracture and scarring and, and how, and what makes fibroblasts, um, basically signal what cause, what causes them to signal. And, um, it was such a good experience that when I came back, uh, into practice, I was recruited by, uh, the local hospital here in the Poconos and I worked, um, as the medical director for, um, for the wound care center, um, was hyperbaric trained.

So I did, we. You know, we had, um, hyperbaric chambers and I had my practice inside the hyperbaric unit and was basically the medical manager for, for the, for the unit. Um, I did that for a couple of years and then was recruited by the, uh, plastic surgery group to come in and develop a limb preservation center for them.

So everything kind of fell into place over time. Uh, And what they really wanted is somebody that could guide, the family doctors that worked in the practice into wound care. So I'd train, I'd give opportunity to train them. And it was fun for me, it was, I would take them into the OR, give these guys surgical experience, and they got to be quite good.

Typically, it took about six months to get these guys trained up to be able to do adequate debridement and to, and to treat wounds effectively. Uh, and then I did, I obviously did the carpentry for the Charcot work and working with two young plastic guys from Columbia who did all the, uh, you know, the muscle flap and soft tissue work.

So that's where we really got into that whole orthoplastic approach, looking at, at wound care as, um, more complex than just a, you know, a, a .... superficial debridement. Um, of course, I've worked with a plastics group. Um, I was, uh, you know, basically trained that I had some additional training on how they look at wounds and all of those guys will do excisional debridement initially on all diabetic wounds, which I found to be a pretty effective.

So what you're doing then, as long as the perfusion is good, because in our group we also had an interventionalist, uh, and we also had a very tough internist that got the protoplasm of the patient right. These, this multi specialty practice is key. Um, but when you do an excisional debridement, you're, you're taking that chronic wound with all the non viable tissue and you, and you have an acute wound.

And as long as the perfusion is good, then you can. heal it. If the perfusion is not good, you have the opportunity to do a reverse muscle flap. There's all kinds of opportunities, but I think sometimes in wound care, we look at wounds too simple. You know, you can't do three days of training and be a wound care doc.

It just doesn't work that way. You really, You really have to have surgical experience. I mean, when I, um, this, when we do research, the centers that I, that I try to pick, the sites I have to pick are guys that I know, plastic surgeons, uh, podiatric surgeons that will do adequate wound care. Um, that way you get, you know, you can get effective, um, research results.

Uh, so it's, it's, um, it's, you know, it's been an exciting ride actually all the way through, but that's, that's really got me, what got me into it is looking at the complexity of it and understanding that every one of these wounds is different. Every patient protoplasm is different. Uh, etiology is different.

Um, the challenges of offloading, As a podiatrist, obviously we do, we tend to do a lot of internal off floating, um, as opposed to external where if there's a bony prominence, we just go in and remove it. Um, and, uh, and those are all the keys really to wound healing. Taking the pressure off and making the wound acute again, getting all that bad stuff out of there and then stimulating these patients.

Because even if the perfusion is good in a diabetic patient, they still have a protoplasm issue. So bringing in the right, um, technology. to stimulate that wound to take it out of that chronic, um, you know, chronic inflammatory phase, which even after a surgical excision within 48 hours, it's back in that stage.

So it's a balancing pH. There's so much involved in this. It's, it's exciting cause it's fun. There's a, there's a, it's fun to be challenged all the time.

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Right. You modify one variable and the patient's body heals itself for the most part, but 20 percent are just fascinating. You know, you have to figure out, okay, we've done everything. What other level can we pull?

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She would walk into the room when I'm with a wound patient and, and I would just be kind of sitting there staring at the wound. And I walked, one day I walked out of the, out of the room and she said to me, what, what are you doing? You're just staring. I said, while I'm staring at that wound, I'm trying to figure out what the approach is going to be.

You're, you know, you're, you're processing, you know, you know, looking at the patient, you're looking at the wound. Um, it's, it's, uh, it's fun. It's challenging, but she didn't, she didn't understand why Just be staring at that wound.

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I didn't realize how many medical missions you had done. I know that you've done some in Haiti, the Dominican Republic and the West Indies, I believe. Uh, what got you into medical missions and specifically medical missions around wound care? And what have you seen or experienced that is interesting?

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It was an amazing experience. To be honest, we did probably the most. And those couple of trips to Haiti they're probably the most monumental and, um, and memorable experiences in my life. the first trip down, uh, in, particularly in Haiti, you're, you're, it's a mass unit, you're sleeping in a tent with 180 people and it's, you know, there's, uh, pallets, uh, to, so you can walk without getting muddy.

And, uh, we were doing, you know, typically. 10 surgeries, uh, local anesthesia, maybe another 10 under general anesthesia every day. We had 60 vacs running KCI donated, um, all the vacs and all the vac supplies. Uh, so of all the units down there, the wound care units were, were the busiest. So, uh, the first time I went down, and I would say not strangely enough, but not so strange because of the experience that podiatrists have, podiatrists seem to be the directors of the wound program when you would go down, and you'd have a couple day transition.

And, uh, and then you take over and then typically I had, um, a number of nurses, um, uh, physical therapists and, um, either dermatologists or other podiatrists that didn't quite have deep wound care experience. And that was almost like a little mini residency. It was, uh, intense.

The first time I went down when, uh, You know, if something happened in, in the unit and they needed, me to get up and do it, they would walk into the tent and just yell out my name, like there's 180 people sleeping there and, you know, you'd have to get up. And eventually they numbered the bed.

So next time I went down, they would just come and tap your bed. But, um, but that really got me involved. Uh, the treating the folks in Haiti, um, they're, they're so stoic and, um, these folks didn't know where they were sleeping, going to sleep that night. They didn't know, um, what, when they were going to eat next.

It was, it changes your view of the world. Um, and I think. People that don't get outside of the U. S. or the Western world don't really get to see what the real world is like. And I think it's important. I think it's really important. That's what got me hooked. So I got involved with a group called Waves of Health and um, and the medical missions down in Haiti were with MediShare with Kisner's group.

And then I got involved with Waves of Health and we did missions to uh, Philippines and Dominican Republic and then Grenada, which, um, you know, just you would think, well, tonight it's, you know, it's an island with a relatively small population. Why would you focus there? Well, it's not just Grenada. All of the West Indies have the highest amputation rate, uh, for diabetic wounds on the planet.

They have almost 100 percent amputation rate. So, um, I got involved with St. George's University, and we were setting up clinics in, and we did set up clinics around Ohio, and I was supported by, uh, by TEI when I was still with TEI. And then, uh, Integra supported us for a while, and then they dropped the support, unfortunately.

But, uh, We did get a clinic set up around the island and I would go down with every month with, uh, I'd take one or two docs with me. And, um, we'd follow, we'd, we'd have follow up on the patients. And that was unique for medical missions because medical missions don't get to follow up. So being able to follow these patients every month, the nursing staff in the West Indies is old school nurses.

They are amazing. They just, they're amazing. They, you know, you give instructions and they give it to the patients. The other thing I noticed too is how grateful the patients are on missions. Like when, when I would go back to Grenada every, every month, if the patient was non compliant, they would come in and apologize to me and say, Doc, I was, I, apologize, noncompliant.

It's it's such a different experience and that could just get you more hooked. So that's really where the medical mission side got in. Uh, so it's been, it was fun. I mean, we were at some, at one point we were going to do, um, and I had other medical, uh, college in the Caribbean call me and say, can we set something up?

Um, You know, I, I take continuing ed with IUHS, uh, they had called me, um, Ross had called me, so it was, we were really looking to expand this throughout the Caribbean, but, uh, we just, you know, at some point, I guess if I, I guess if I won the Powerball, I would, I would just fund it and do it myself.

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To have any help and to have world class help is just, it's, it's like a miracle for many of these patients and, uh, especially, you know, the diabetic patients. I mean, they are just suffering and you, you see them and they have untreated wounds, um, that had been festering for years. You know, and, um, you know, it's the work that you've done in the Caribbean and abroad is just, I can only imagine the value that that brought to those communities.

And hopefully you'll win the Powerball.

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It's, uh, and these countries are independent. They're not, uh, they're not colonies anymore. So they're, they're relying on, uh, on their, on their own. People to take to take care of them what they with the funds that they have. I will have to give them kudos though. The The quality the quality and dedication to healthcare professionals down there is amazing

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So you, you, you've done a lot of clinical care and I think that's when we met, we met in the realm of research. Uh, I did not quite understand how much work you had done clinically, uh, prior to that. And so, uh, as we were preparing for the show, it was really interesting to see the breadth of your experience and, and the work you've done.

Um. Talking about research. So you're a clinician, you're doing medical missions, you, your, your hand to hand combat in terms of, of, of wounds. Um, what kind of drove your pivot into, into research and kind of focusing on that in the latter part of your career?

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And then, then you're looking at the sites and evaluating the sites. I think trying to get accurate data that's real world is important.

Um, and like you and I have spoken about this. I think registries are becoming more important. I think retrospective data has always been frowned upon. But the reality is retrospective data is good data. And then with small companies, they don't have. 3 or 4 million like Integra spent 18 million on their RCT.

I mean, little company, young companies, they can't afford that. So trying to develop a prospective study and picking sites where the clinician is more interested in the data than in the money, um, became kind of an interest to me. So I've been able to, to do set up some of those pro, and you know, prospective studies we do.

And they're, and it's, it's good research because really what you're doing is looking at how the product works now with a prospective study, you're not going to have a. a control group, but you can always look at retrospective control. And some people may say that that's bad science, but others may say that I, I would disagree.

Um, the only difference really is that when you're, when you do an RCT is that you have to have control of the, of the standard of care as well. So you're standardizing the standard of care. Um, and that becomes that, and it's what adds to the expense plus, um, cost per patient. It's expensive. I mean, ultimately, the way the FDA works now and approvals work with CMS, um, RCTs are still going to be required.

I'm just trying to find the most effective way to do it is going to be the challenge. And, you know, I haven't Spoken, uh, with CROs and the cost of doing a 120 patient study or you're really you're talking like if it's a three arm study, you're talking 3, 000, 000. That's a lot of money for a small company to put out.

It doesn't have to be that way. If you can do these studies in house. And pay the going rate. I mean, all the, all of the clinicians that I've talked to at the sites that we have right now are, are, are willing to work at the standard rate for patient. You don't have to, you don't have to, you know, gouge the system.

So I guess a lot of it is just, you know, I'm getting to the point in my life where if I see something that doesn't make sense, I just. kind of say it. And, uh, we'll see, you know, we'll see where things go. And, and these prospective studies can be converted to. So if you start as a prospective study, you already have an inclusion exclusion criteria.

Um, you're just going to have to add in the, the, uh, randomization and then, and then the standardization of control. And, um, so you've already got a site that's IRB approved. You can modify that study. It cuts the cost. You already have the blueprint and you already have sites set up. So starting it as a prospective study and then rolling it into an RCT, I think makes good sense for a young company.

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5 is probably reasonable. You know, the studies, If you try to control the study to get that kind of A1c, you'll never have any patients enrolled. So now you're starting with patients that are going to have really an unreasonable A1c. Um, and I just, for me, it's hard to, um, intellectualize how any of this data is real.

I mean, it, it, it's like when I was doing my research, I was where, I was looking at, um, transcytosis of, of beta 1 integrins. So I was transfecting my cells. I was putting them putting in labeled, you know, you basically label a color onto the, onto the protein and then transfected in this cell. So I'm transfecting all of this, all these proteins into the cell and then, you know, doing fluorescent microscopy to track the, to track the transcytosis, right?

So I went to my PI one day and I said, none of this data is real, is it? And she said, what do you mean? I said, well, these cells don't have this natural amount of protein. I'm transfecting tons of protein into these cells, changing their whole cellular metabolism. How is that real? She didn't like that too much.

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And they go, what do you mean? I said, well, in the real world, and I've seen thousands of these specific types of shapes, the tail on the right is very long. Your tail ends here. At 120, that's impossible, you know, and they go, and finally they go, Oh, well, we took out these people from the sample, et cetera.

And I'm like, but you can't, then you've just invalidated

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and so I think. To your point, as you kind of travel and you look at things, you start asking questions as to that data can't be real. It just doesn't make sense. It's not representative of the real world. Um, and I think in our conversations, what I've enjoyed is It's talking to someone who does this as a living, who's trying to get studies and, and, and information and really advance, uh, wound care, but at the same time being incredibly realistic with the people they work with to say, Hey guys, if we're going to do it, let's do it the right way, you know, and I've always admired that.

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The problem with research, clinical research, is the cost of clinical research is, is out of small companies that are coming out with exceptional technology. There's so much good technology coming out now, changes in, advances in treating natural products like placental products, um, you know, new scaffolds coming out that are synthetic as opposed to natural.

But, but just understand necessary. I guess, um, I mean, a good example, this is, you know, if you look at every scaffold out there and I've always been a big scaffold fan, scaffolds are best as a temporizer. Um, so if you have a full thickness, large wound and you want to reduce contracture, so, so it will, it'll slowly granulate and over time, um, that's what their best use is.

Fibroblasts will, will migrate on any natural scaffold, but fibroblasts. won't signal that maximum effect unless there's fibronectin on that scaffold. For instance, I'm to get a little, a little wonky here, but, but that's a protein that's essential for fibroblasts. To attach. When a fibroblast attaches to a scaffold, that's when they pump out everything.

They pump out at maximum capacity. So unless you add something to that scaffold to make it more effective, um, you know, it, you know, it's just a scaffold. So for me, looking at, um, all of these products and understanding that at each stage of wound healing products, um, need to be changed. It's not set up that way.

It's a weird system. You know, no one product is good for that wound throughout the healing process. You can never lock into one product and say, okay, I'm just going to use this until I burn out my 12 uses or whatever. Um, if, you know, if you use it, if you use a scaffold, a good debridement, use a scaffold effectively and And let that scaffold, um, granulate in, then you can move to something like a placental product that will, um, bump that, uh, wound healing process from inflammatory to proliferative and get it to heal, or go to a skin graft, but you, there's always stages.

I mean, working with burn surgeons, that's how they look at the world. They treat burns exactly like that. And then when they treat wounds. They treat their wounds like they treat their burns. So I think burn centers that are doing wound care now are, are, are definitely going to be more effective over time because those guys are trained that way.

They think that way. They say, well, no, what I'm not going to use one thing forever. And, and then a lot of these products using them every day. Like if you use a. For example, if you use a placental product and it has chorion in it, you're always going to get some sort of foreign body reaction. If you use that product every week, you're going to get hypergranulation.

You should understand that. So every doc should understand that. I guess the advantage I have is that when I go in with a rep, I can give, I can do the science with the doc. And we can. Talk about, um, when this is best used and when maybe something else might be better and I, and I just gave a talk in Montana on exactly that topic, saying that guys need to know when to, when to switch, you need to know, you know, when to use what, and nobody talks about that.

You know, it's, uh, I think that's, uh, that's the, change that we have to make in wound care right now is that we get too locked into one product. And with all the new products out there, if everyone was used, if every one of these products was used effectively, the cost would go down and CMS would save money.

Um, it's just the right way to do things.

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And I'm thinking to myself, is anyone who actually wrote this practiced in wound care? Because there's nothing linear about these types of wounds. And applying this linear rule, you know.

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to start making guidance decisions on the ability to switch products in, in midstream, um, the ability to move to another product. Why do we wait four weeks, uh, before we can use a product if this patient has been, had a chronic wound forever? And then you have to treat them. I mean, there's a point to that, just like a lead into a research project where, you know, if you, if you do a good debridement and there's good perfusion, yes, some of these wounds will heal, but the 20%, like to your point that will not heal, why wait four weeks?

When just not like, like in a clinical research project, just wait, you know, a week or two and, and not let that patient continue to have this chronic wound with a chance of deeper infection and more pathology, just, you know, move on to wound healing CMS isn't set up that way and it's kind of weird the way they are set up and what they require again for these young companies that have great technology, you know, just some of that stuff needs to be changed.

I don't think you should require somebody to spend, you know, three or 5 million in an RCT that's going to give you manipulated data in many cases anyway, just to say, okay, you're, you're in now. It's like, it's like pay to play. Doesn't make sense?

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That goes on, right? Uh, people hack their way to that magic p value and they say, well, there's a, you know, a 95 percent chance that this works without realizing that a p value isn't saying that. A p value is a declaration that the data you will see is, uh, well, I'll have to say this very slowly because I confuse myself at times with this definition, which is a clear sign as to why it's important.

It's wrong. But a p value isn't that 95 percent of the time, the data that you observe with the theory that you are proposing will be true. It is a contrary to the null hypothesis, and it says that the data that you see will be more extreme than the null hypothesis. If you were to simulate that. Infinite times.

Well, even just saying it is confusing, right? Right. And so, people hack towards that number and they say, well, we've got our number. And to your point, I think, uh, a lot of the research throws away anecdotal data or, uh, retrospective data. Or even that the priors that people like you may carry. about how a model should work.

And, you know, one of the things that I'm being excited of working with you and working with other people is to use methods, such as Bayesian methods, where we can put this information, these models, and then look at what the posterior distributions are versus a p value. Um, and I think that's, what's really exciting is that, uh, the FDA actually is going to be is understands the Bayesian method and next year they're releasing, uh, guidance on how they will accept Bayesian methods.

And I think particularly in care. Particularly because of the heterogeneity of the patients. Correct. But the heterogeneity of patients between time, the very same patient, to your point, can change incredibly over the lifeline of their treatment. So at time point 11, it's not the same patient. person as time point two.

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We, we talk a lot about, uh, pressure ulcers or tear ulcers or venous ulcers, but burns, uh, you've talked to me a lot about burns and I've been incredibly fascinated by the burn world because I know very little about it and you've talked a little bit about it, but compare and contrast the burn world or the burn, Patient base or the protocols and you've done that a little bit already, uh, but can you kind of dig a little bit deeper around that?

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So it's the wound is contracture is not going to be a big deal, but you still have to cover that wound. Um, because it's exposed for infection, which in a burn is just a wound and stimulate quick infection. some sort of granulation tissue and then move on to a skin graft. Uh, the more superficial, uh, partial thickness burns, they just put typically put a skin graft on a, so when burn there's this, um, movement now.

And I was just at the Boswick meeting, where in talking to some of the burn surgeons that I had dinner with and had time with is to move away from using, a split thickness skin graft in these patients and try to get, um, you know, some sort of technique, and I think placental products are probably going to play this role, particularly amniotic products, depending how they're processed, to stimulate a very solid, ECM that will allow, , epithelialization to happen naturally.

And that will save, that saves the donor site on these patients. You can also bring in a bigger wound, a CEA like Resell or something like that, some other product like that, but that gets expensive. So when burn centers run on a margin where it's a losing proposition basically, these patients, um, cost more than the hospital can, can make on these patients.

The burn centers are more altruistic. The burn surgeons tend to be a little, they're, they're, they're clinically more focused on, on healing patients than about The money side. Um, that's my enjoyment working with those guys is I, I respect them so much. Uh, but their, their model is to use as little, is to spend as little money as possible on, on product.

So, but you still need the products. So if you have a full thickness burn, then their goal is to put a temporizer in there. Temporizers come in a lot of flavors of synthetic temporizers. There's, old line temporizers like Integra, but so then it comes down to cost. So then they'll look at in, in both the buyer and the doctor look at cost in these products.

When you get to the partial thickness, it's going to be the same thing. It's going to be cost. So then it's working with. The company and working with, um, the distributors and trying to get to the point where everybody's happy on pricing and you can get, and you can, you can fix the patient without, you know, without breaking the bank, basically.

So that's kind of the challenge they have is cost because they're dealing with. Wounds, you know, the average burn size is about a thousand square centimeters. So it's not, not little wounds that they're dealing with. But these guys are, are, are very smart. It's fun talking to burn surgeons. A lot of them are plastic surgeons.

Um, our dinner conversations are fun to have. They're interesting and a lot of good questions. And it's good. And then you're helping these, you're helping these patients. A lot of them, like when I was working in the Southwest, a lot of them are kids that come up from Mexico. And they're doing these patients pro bono, um, they cook over fires, kids fall in fires, they get these burns.

And again, most of them are deep partial thickness, but they have to be treated. And then they're lost to follow up, a lot of these patients, so you want to be sure when they leave, they're on the road to healing, because you're not going to get to follow. So it's an interesting business, the burn business, um, but I think, but it's wound care.

I mean, basically, a burn is a wound. that's the bottom line. Uh, what used to be called the third degree burn, which is a full thickness burn, is basically after you do sequential debridement, you've removed all the non viable tissue. It ends up just being a full thickness wound. That's what you're dealing with.

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With these pediatric wounds or I'm guessing also a lot of occupational burn wounds, right?

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I remember the most severe case I can remember. I was in California with, at the Grossman Center, which is now part of UCLA. And, uh, guy, guy came in, uh, worked at a chemical plant. You know, they fell into a vat of chemicals, 95 percent chemical burn.

And there's still an attempt to try to save a patient like that. But at that point, at that level, it's, You know, it's just a matter of comfort. And, uh, but yeah, some of the stuff that comes in can be pretty nasty for these guys, but I, I totally respect that community, a lot, I think, they do everything, They do every, they seem to do everything right, and I think, I think wound care could learn from the burn community.

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So what I've seen like in Boswick over the years, for instance, which is the big burn meeting in, uh, in Maui, that, that meeting has changed, has evolved from a burn meeting to a burn slash wound meeting. Um, North American burn, same thing that, uh, that meeting is evolving from a burn meeting into a burn slash wound meeting.

And these, these, uh, specialties are coming together and I think that's good for, for wound care. I think it is, it's good to have these guys, um, involved because they have so much to offer to the wound care community.

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an, you are writing things in: 2006

But then you have other, uh, actors in the field that are maybe not as reputable. Let's just put it that way. Um, where do you see this going and given your view over the whole lifeline of, of biologics and where do you think it is going? Where do you think it should go?

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Um, or somebody has to play a big role in explaining mechanism of action on these products. I'll give you an example of a rep will come into a clinic and say, um, we, this product has 600 growth factors in cytokines. Let's just say, you know, rep will say that. And then, uh, nobody ever challenges that and says, well, that's amazing.

We should try it. Right. Nobody asked the question, well, what are the, what are those growth factors? Or what are the concentrations? Are they physiologically, do you have enough concentrations to make it physiologically active? So those, those are questions that need to be asked and, and need not to run. I work with reps all the time.

I love them. I love where I learned more from reps sometimes than I do from anybody else. Some of them are amazingly astute and well educated, and they're great people. But, you know, they're working for a company, pitching the company line. Uh, but I think. We have to educate them more on what's important and we, and then we should have a wound care has very little backup for them.

So I think the rep is the frontline to me, but having somebody to be able to, like, I get called by these guys all the time with questions and, um, or they'll put me on the phone with the doc and I can answer questions. But a lot of companies don't have a backup for the, for these guys, this role that, that I started with.

When I started with TEI, it wasn't even a role, you know, being a medical education director or whatever. Um, it's like an MSL role, but kind of on steroids because an MSL has science background. You know, they can explain the science, but they can't, they can't, uh, they can't connect the dots, you know, as Carlos Santana would say, connect the molecules to the light, you know, it's taking how the science works physiologically, uh, clinically.

Because you have to be able to, to, um, see how these products work. So I haven't, you know, I have had years of clinical experience and used all the different categories of, of, uh, biologics. I could, I saw how they worked. And then, you know, having a little bit better background in science helps you understand why they work.

So I think that has to be brought out. Like when, like, then you would understand what, when to use the product. So I have a deep wound. I'm worried about this contracting because if it contracts too much, it's going to be weakened and its recurrence rate is going to be higher. How can I prevent that? Those are the questions wound care docs should be asking or, um, like this wound is stuck in this inflammatory phase.

You know, what do I have to do? You have to change the pH for one thing, right? You have to get it out of that alkaline pH and then you have to, uh, put growth factors and cytokines that the patient doesn't have anymore because of their protoplasm that will take them out of the inflammatory phase into proliferative phase.

So you're looking for specific anti inflammatory cytokines. So, you know, all these wounds have very high concentrations for instance of interleukin 1 beta. So what, how can we, knock that down. How could we, how we can, can we prevent macrophages from pumping those out? Well, you need to block the receptor, um, that the, you know, the beta, the interleukin 1 beta receptor.

So which of these products have a high concentration of interleukin, um, 1 RA? the receptor antagonist. So that's, and that's not, it's not a lot of science, but it's enough to be able to use these products effectively. So a wound care doc should know that he should say, okay. I'm stuck in this phase. What are the things that I can do to change this?

And then you can pick the appropriate product. You look at their profiles. Take a look at what they offer. Take a look at how they're processed. You know a lot of these side growth facts and cytokines have a, uh, are very fragile. They're not collagen. They're not a tightly bound triple helix. They're, you know, they're ribbon proteins that, that if you use any kind of heat or bleach or anything, it breaks them down right away.

So you have, you kind of should know all that stuff if you're a wound care doc, um, and add that to your clinical background. So that's, that's where it's going. I think it has to, it, where it's going. And I would always say this anyway, cause I'm an educator. I would say it's, it's going to be education. You know, you go to wound care meetings, There's not a lot of, unless you go to like, unless you go to WHS lectures, there's not a lot of, um, there's not a lot of science behind the talks that are, I mean, there's some great meetings out there.

The innovation meetings I think are awesome. Um, the WHS lectures at SAWC are awesome. But those are lectures that, Um, give you that education and because the other standard wound care lectures are, are the same every year, they're just standard wound care lectures. I mean, if I won't mention names, but I've, I've seen these guys speak and it's the same talk every time.

It's like, no, there's no change in, in that talk. So, you know, go, go after the science. That's going to be the change in using biologics. You have to use them intelligently or else CMS is going to take them away

[: 00:54:15

And we've whittled it down and narrowed the science down to where we know generally what works on average, where wisdom or expertise kicks in is where will it work, not on average, right? And that comes to what you described, knowing the science. And, and, and really having that expertise to make the right decision at the right time.

We've talked about this, but one of the things that, that, that is my passion is saying, okay, we've got the scientists who are really driving away at finding the right products. We've got the clinicians that are really getting good at the clinical science and really getting that nice, tightly wound and ready to go.

But our statistical models or quantification needs to needs to be up there in order to be more sophisticated, more flexible to allow people to acetate. Is there a treatment effect or not? Right? Like, that's, where I, from a statistical perspective, I think we need to go and it's, it's, it's really interesting sitting on one side of it and listening to someone like you saying, okay, let's get into the science, let's get into the chemistry, let's get into the biology, the microbiology.

This is what's going on. We should be able to articulate that quantitatively. Yeah. So, yeah.

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That's where like the burn guys, they're not restricted. They go for it, you know. But, uh, you know, that's what we need. We need to be able to, we need to have more freedom. And, um, and, and I guess the, the, the problem with that is if you give too much freedom, you're always going to have that percentage of clinicians that are more in for the money.

And I hate to say it, but, you know, you see, you and I see it, it's, it's frustrating. You know, it's not the oath. The oath we take is to do no harm and doing something for the money is just wrong.

[: 00:57:31

Um, and I think what is interesting in the conversation, and again, there are financial constraints. We all get that. Um, but I've talked to a lot of people and I've said you do know if you force someone to make a bad decision at an earlier time point where you're saving cost. At that particular time point, you can incur more cost in the long run.

[: 00:58:08

So not to get into specific examples, but, okay. You know, it's really just understanding that there's all kinds of techniques out there. Just get out there and constantly learn. But a wound care doc has to constantly learn. They have to be educated constantly. Uh, I think the meetings could do better, but the variety of meetings that a wound care doc goes to I think is helpful.

So that's my suggestion to all the wound care doc guys out there. Go to a burn meeting, um, particularly something like, uh, NABs or, or Boswick, uh, or even one of the regional burn meetings and, and go to their lectures, you know, go to the innovations meetings where, where this, you know, the new products are coming out, you know, see what's coming down the road.

I mean, all the synthetics and everything that's coming down the road, be educated. Um, you WC good conference, but, uh, it's not the only one out there. You know, you could mix it up a little.

[: 00:59:23

I always enjoy speaking to you. And, uh, I just, I'm, I'm still astounded at times by how much, you know, about the science and the education and the history that you've had in wound care. And again, I think our view of viewers and our listeners, uh, will have learned a lot during this. So I really appreciate your time.

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