In this episode we look at the role of textiles in healthcare, and how textiles can make an impact on patients, healthcare providers, and industry. More specifically, we explore how textiles are employed in the clinic for the treatment of chronic wounds, and the journey that researchers and clinicians take together to translate an idea for wound management from the lab into the clinic.

This episode is hosted by Dr Giuseppe Tronci Associate Professor in Healthcare Materials at the University of Leeds. He is joined by:

• Begonya Alcacer-Pitarch - clinical Lecturer and healthcare professional at Chapel Allerton Hospital Leeds
• Dr Graeme Howling - Senior Innovation Manager Medipex Limited
• Dr. Charles Brooker - Postdoctoral Research Fellow at the University of Leeds.

Related links/articles:

1. A long-lasting guided bone regeneration membrane from sequentially functionalised photoactive atelocollagen
2. Hydrolytic Degradability, Cell Tolerance and On-Demand Antibacterial Effect of Electrospun Photodynamically Active Fibres
3. Protease-sensitive atelocollagen hydrogels promote healing in a diabetic wound model

Giuseppe: Hello and welcome to the Global Challenge Podcast hosted by the Leeds Institute of Textiles and Colour or LITAC, as we have abbreviated it too. We have created this podcast series to shine a light on some of the research that is happening in LITAC, and to provide some insight into what we can collectively do to address the pressing challenges that we are all facing.

By doing this, we want to break down some of the big challenges and provide some perspectives on research and innovative solutions for the benefit of our society.

I will be discussing this topic with the arch Begonya Alcacer-Pitarch, who is a clinical lecturer and healthcare professional at Chapel Allerton Hospital Leeds, Dr Graeme Howling, who is Senior Innovation Manager with Medipex Limited. And Dr. Charles Brooker, who is a Postdoctoral Research Fellow at the University of Leeds.

Begonya: Yeah, sure. Good afternoon everyone. So basically we go to the basics of what happen through the wound healing process. A normal wound as such, will go through four phases and is what we call the hemostasis phase, inflammatory phase, proliferation and remodeling. There is a period of time attached to it. It depends on the type of wound and how it's been produced, but within it, it has a healing process. Within a standard time. We start considering that wound is a chronic wound when it starts getting to week four or week six, and it has not healed. Then between this timeline is where clinicians start considering that the wound becomes chronic and it's not responding to specific treat. So treatment becomes really [00:03:00] important in this case because these wounds have an impact not only to the patient, in the aspect that it has an impact on the health and also on the quality of life, but also it has a financial cost. Knowing the problems that we have financially with health providers in general is certainly very important that we need to consider this as well.

Chronic wounds have been determined to cost around $20 billions per year in the United States, and around £five billions, goes to the NHS in the UK. We can see that they has a big impact financially as well to the cost of the NHS. Now where textiles really play a role for us, from the point of view of clinicians and how do, we use the textile world in terms of dressings.

Giuseppe: Thank you very much Begonya you have outlined why textiles are so important in terms of the management of the wound, and you have also mentioned that textile based product are routinely used in the clinic. Obviously we see that wound management , is still a burden in NHS and worldwide. So can you describe what are the main limitations of these products? In order for us to shine light of how the next generation development can address, these challenges better.

This causes the problem that the clinicians, they are unsure about the optimal treatments. So which dressing have better efficacy for certain stages of the wound healing. You always tend to see that in numbers of the trials that are published is very small numbers and the design of this study is not high quality. This then leave us with kind of not knowing exactly what dressing would be the best, or telling us in more clarity what dressing would aid different stages of the healing. We know the basics of it. You would have certain dressings that would, work better for infection, for example, and then you choose that, or if there is more pain. But we still having these problems where we need more development with those dressings that will control, or maybe determine when an infection.[00:06:00] is present because it is not only going to aid the clinician, but it will also aid the patient when they're at home changing the dressing where they can tell that the wound is changing the pH due to an infection, for example. Then they can contact us early so we can intervene in an earlier stage.

Begonya: So pain is another issue how do we remove the dressings and the adherence of the dressings to the wound bed, that it could disrupt the healing if it adheres to it? By all means the usability of these dressings, that's another issue that we tend to have, how well the dressing conforms to the wound area as then it reduces the pain and it also is more in contact with the wound bed to aid the healing in itself.

However, most of these wounds you they would present with pain. Currently the main use is analgesia. So they'll use like you know, systemic drugs to be able to control the pain. This also exposes the patient to the consumption of higher numbers of analgesia where we could develop dressings, that we could control the pain more locally. Maybe we would find that there is a big reduction in oral or systemic analgesia, which it would be a benefit of overall for the patient.

Charles: Much of the research and development currently going on builds off of textiles because textiles have a great structure or architecture for wound healing. So they have a fibrous structure, a porous structure, and that means they have the ability to absorb excess wound exudate. So that's very important in these exuding wounds is you mentioned. At the same time, these dressings can keep the wound bed environment moist, which is ideal for encouraging the progression of wound healing. In terms of the current developments, there's lots going on in this space. [00:10:00] We've seen the rise of electronic textiles or e textiles, which you may have seen in wearable technology over the last 10 years or so.

So we have smart watches and smart clothes that monitor activity. And these could be adapted to produce smart diagnostic textiles that provide continuous physiological monitoring of a wound. And that may cut down number of trips to a clinic. So that will save on cost as well. We don't have to stop with these relatively straightforward things.

There's a, the self-tying shoes from Back to the Future 2. They exist now in real life. They've been made. So why couldn't we have self-tying sutures or stitches? Why does the surgeon have to do that themselves? Why couldn't we have a material that does that itself? Obviously currently it'll be due to cost, but this is why we need to do the research and development to get these things closer to actually being useful in the clinic.

Charles: In terms of antimicrobial resistance, that Begonya mentioned. I think most people are aware of the threat that the antimicrobial resistance poses. Unfortunately, we can't just come up with new antibiotics. It's not that straightforward, It's time consuming, It's costly. There are not enough antibiotics currently in development to keep pace with evolving bacteria.

And all of these materials have been incorporated into textiles and have been shown to have strong antibacterial effects. [00:13:00] So this is where we are currently in terms of. The research stage and potentially what's coming through in the near future.

Giuseppe: Okay. Thank you Charlie. That was very helpful. So obviously by integrating these new functions and these new materials into textiles, we also need to be mindful of the manufacturing routes that we pursue. Obviously, we don't only want to make the prototype in the lab at a small scale, we also want to make sure that the manufacturing route we pursue is developed enough to be transferred to the industry and for scale up and development.

Charles: So just to talk about some of the work we're doing in Leeds well, we have a number of different products or. Areas of research, and as you said, there are different stages of readiness. So the closest we are, I think we are putting together an application for a first in human clinical trial.

So that's one of the big steps before we can get into the clinic. In terms of other work we are looking at, we are looking at smart materials, materials that respond to external stimuli to produce a specific response. There's all sorts of uses for this. This could be used in drug delivery. It could be used in tissue engineering scaffolds, but they could also be used in wind dressings.

Charles: Obviously there are a number of steps before you go into the clinical trials. This is all just to minimize risk. So when you've come up with an idea, let's say you are producing a polymer you'll want to characterize it first and foremost. Does it perform how you expect it to perform? You can conduct mechanical tests. Your material performs well in the mechanical tests then you might want to check whether the material is cytotoxic, so not toxic to cells. To do this, we'll first usually do invitro tests, so that means we grow themselves in a lab and then we can conduct some relatively simple experiments to determine if the cells are happy to grow. Or if the material kills the cells or a portion of the cells. It's a good idea to conduct these tests alongside materials that are currently on the market. So for example, if we were producing a new wound dressing, we would conduct our mechanical tests and compatibility tests alongside a range of currently available commercial products. Then we would want to show that [00:16:00] our new product has superior properties either mechanically, or in terms of wind healing, obviously ideally both.

Once you've done the in vitro tests, you might want to move on to the Invivo studies. So these are the animal studies. So in recent years, there's been a push to reduce the amount of animal testing conducted for obvious reasons, but in terms of gathering meaningful data invivo testing is more relevant to real life environment. In the invivo environment, in the animal, there's more sort of kinetics. There's more relevance to a human. Now there's still unanswered questions from the invivo study, and that's why afterwards you would move on to the clinical trial. But these are all of the steps you'd need before you get there.

Graeme: .The translational journey can be really complex and it can take a great deal of time and effort however that shouldn't put researchers off who have innovation ideas. Developing new textile technologies for medical use involves working with clinicians like Begonya, healthcare workers, engineers.

Charlie mentioned that you would start doing simple lab testing and moving on to animal work and then going into clinical trials and I guess, the big recent changes are the new regulations which require a great deal, more clinical data and clinical evidence before products can be put on the market.

Giuseppe: Yeah, and I think with that regard we will start to see more calls for this type of development work where there is the possibility to build regulatory packages in the project to enable a successful completion. I would like to go back to Begonya, you work at Chapel Allerton Hospital you treat patients every day that are affected by multiple types of wounds. Can you give us some Insight on how your clinic works in terms of patient management, with respect to clinical innovation and clinical trials?

So basically our aim in our clinic is obviously improved patient care, but in particular we focusing a lot onto the development of new treatments for patients with connective tissue disorders and wounds. At the current moment we are doing a trial, NIHR funded, which is the SHED Study, which is a early stages feasibility study, and we want to look at the efficacy of sharp-debridement onto the wound bed and how that affects the healing process? Is it improving, is it reducing infection we don't know? As we were saying before, with regards to wound care treatment, there is little evidence out there. So this is the trial that's going, but also we are doing the trial where we want to test the HyFaCol.

We’ve discussed about pain management, we’ve discussed about infection control. By having a clinical perspective in the team is definitely helpful in order to tailor the technology development towards defined clinical needs. With that regard, obviously Graham was pointing out the need of regulatory expertise. Graham, maybe you can give us some hints about what can we do in order to enable better engagement your perspective.

Then, industry will be interested in working with you, and co-development that product to, and bringing it on the market.

Charlie, maybe you can give a sense of what your journey was. To come where you are in terms of this technology that you're developing at LITAC what's your experience of working in this multidisciplinary setting

Charles: It’s very exciting work, but it's very important that sort of at each aspect of the work, everyone's sort of in alignment and they know what's going on. So clinicians are incredibly important because you can have a great idea.You know, maybe you'll, if you're working on wound dressing, you can increase the healing 20% quicker, for example. Do they need that? Do they need it enough? Are they willing to change current procedures to introduce a new dressing you know? Are there enough of this sort of injury that needs treating to make the product viable?

And then again, if you want to commercialise it, you may talk to industry and it's okay having something in a lab that could be manufactured in a lab, but the industry might say, Well, we can't scale this up to the production levels that you would require to make this commercial. So there has to be communication all the time across all these different disciplines and you have to make sure that everyone's on board and you know, has something that really can make a difference.

Charles: So this is always a very difficult balance when you have to compete the interests of IP and the interests of research and getting publications. So obviously once you've protected something, then you can start to talk about it. So in the early stages, there'll be a lot of holding back on publishable work because it has to be, no one else can know about it until that point. Then you have to think about, is this potentially something that could be patented in the near future? If so, then you won't be able to talk about it or at least talk about it in an explicit way. So there are ways, perhaps of creating content, creating papers within an area perhaps. Discussing a review of or a perspective of what could come forward without going into the details, but you're right, it is quite tricky to balance those two competing aspects.[00:26:00]

Giuseppe: Thank you Charlie. So I think we've got quite an overview today. The different environments that we need to navigate through with respect to textile materials and products for healthcare. We have discussed about the clinical challenges, the technology development challenges in terms of regulations and industrial engagement. With this in mind, I would like to thank you all for listening and to Begonya, Graham and Charles for participating in this podcast. Don't forget to follow and subscribe wherever you listen to this podcast so you don't have to miss the episode.