Managing Chronic and Complex Wounds with Synthetic Hybrid-Scale Fiber Matrix

Dr. Thea Price discusses the details of her article, Use of a Synthetic Hybrid-Scale Fiber Matrix in the Management of Chronic and Complex Wounds: A Retrospective Case Series. Read the full paper here.
 

Transcript:

I'm Dr. Thea Price. I am an acute care surgeon, traumatologist, wound care director and burn surgeon at Rush University Medical Center in Chicago, Illinois. So I became a wound care surgeon when I took my first job in 2017 because I had really developed a passion and love for acute and chronic wounds after my burn fellowship. But as I investigated more and more what I was interested in, it seemed as though I was more interested in all types of wounds as opposed to just burns. And that's part of why I moved into the acute and chronic complex wound arena.

When that started happening, it was around the same time as the explosion of skin substitutes across the market. My background is that I have a basic science lab that studies wound healing. And so I felt that with the emergence, an explosion of all of these skin substitutes and dermal replacements on the market, and with my unique history of having the burn surgery training, but also the basic science lab that studies wound healing, it almost felt as though it was my duty to be somebody who would critically evaluate these skin substitutes and try to determine, in what capacity are they the most useful and in what patient population do they help the most?

And so in order to do that, I really looked at it from a scientific perspective, and this skin substitute in particular was really fascinating to me as a scientist because it's fully synthetic. This was interesting to me as a surgeon scientist because almost all other skin substitutes on the market are biologically derived, which means that they come from some sort of animal like another human sometimes, or we also have ones that come from shark, that come from pig, that come from cow. What's unique about those biologic skin substitutes is that they have to undergo a terminal sterilization process, and that terminal sterilization process prevents the transmission of prionic and viral diseases to the patient, but it also punches big holes in the extracellular matrix, that is the scaffold that I've described. The biologic skin substitutes will say that this is overcome by the active cells that they have in the product as well, and that that in addition to the incomplete extracellular matrix is enough to cause wound healing and they're correct.

But what I was really fascinated in was, is this was the first fully synthetic that has a fully intact extracellular matrix that's made to look exactly like human dermis. It seems as though there was a perfect opportunity to answer a question that I had been pondering for several years, which was what's actually more important to the wound? Is it the structure? Is it that scaffold? Is it that roadmap to travel or is it these active cells, these regulatory cells, the VEGF, things like that, that will promote angiogenesis? And so that's really why I decided early on in the inception of this product to be an early user and really see what it's good for. Because of that, you're going to see that my case series has basically patients who come from all backgrounds, who are all ages and have all sorts of different demographic data and comorbidities.

While I do think it's difficult to generalize treatment in such a diverse population, I do feel that it's important to take all comers when you're evaluating a new skin substitute so that you can really critically evaluate what it's going to be helpful for and what it's not going to be helpful for in the future. I mean, this is how science makes it to the end user, is that there must be a clinician who is willing to critically evaluate it and see what it does and what it doesn't do. So in this study, you'll really find a broad demographic and a broad spectrum of patients treated. And again, I think that's really important because then you can start to put together in your own mind, what patients are this good for.

There was one result, so in the patient who I mentioned who had necrotizing fasciitis of her left posterior thigh, her entire circumferential left posterior calf and then her bilateral TMAs at different time points. When she came in with the left lower extremity necrotizing fasciitis that included her calf and her posterior thigh, they were both basically skeletonized. The left lower extremity circumferential calf was skeletonized down to the muscle layer and the posterior thigh was down to the subcutaneous layer. She's also a poorly controlled diabetic, has bad peripheral arterial disease, and is largely non-compliant, and so, a very difficult patient. So what I was really shocked by is, we took her after her first debridement on her second look, all the wounds appeared very clean. And so we applied a single application of Restrata. And what was really amazing to me was that her posterior thigh healed incredibly rapidly, far faster than that 10% per week wound closure that we rely on as gold standard, because that's how fast a person would heal if they were in complete normal total health and had an acute wound, and we only ever had to do a single application.

To her calf, it was very similar. We skin grafted after a single application because we had a great wound bed. So that I found largely surprising and honestly, in all of these patients, what I found surprising as well, is that most skin substitutes require that you replace it every week. But because Restrata is more resistant to the disintegration and the degradation, it often stays in place for up to 3 weeks, which is really nice when you're seeing patients on an outpatient basis because they don't have to come and see you every single week, which for wound patients can be quite onerous. So I think I found it surprising that that patient healed so well just because before that any wound that she had would really heal at a snail's pace, and this was the only thing that had changed.

What needs to happen next and what I am personally committed to is, now it's time to have head-to-head comparisons of skin substitutes. So almost every skin substitute on the market has had their initial case series where they've talked about their experience in certain wounds. But what we are lacking is, okay, so you say that your skin substitute is really good for VLUs, now it's time to have a head-to-head of skin substitutes for VLUs in a randomized, controlled fashion so that we can actually start to answer the question, what differentiates these?

Because they all work. They just all work in different ways and best in different circumstances. And so without doing those head-to-head comparisons, I don't believe that we'll ever get truly the answer of what skin substitutes are best for which wounds.

It is my hope that as these skin substitutes progress, that we really will enter an era of technology where we no longer have to think about doing these massive reconstructions on patients because my hope for the future is that we will literally get to a place where we can cause tissue regeneration or, as I like to say it, grow people back like a starfish