RECELL® Spray-On™ Skin Cells: Innovation for Closure of Full-thickness Wounds

07/24/2024

Any views and opinions expressed are those of the author(s) and/or participants and do not necessarily reflect the views, policy, or position of the Wound Care Learning Network or HMP Global, their employees, and affiliates.

Join Dr. Lisa Gould, Plastic Surgeon, as she shares her clinical experience using RECELL Spray-On Skin Cells. The RECELL System technology platform treats patients with thermal burn wounds and full-thickness skin defects and is used for re-pigmentation of stable depigmented vitiligo lesions by harnessing the regenerative properties of a patient’s own skin to create Spray-On Skin™ cells.

Transcript:

Brad Wiggins, BSN, RN, CBRN:
Hello, and thank you for joining us here at the 2024 SAWC meeting in Orlando, Florida. We're excited to be able to have Dr. Lisa Gould join us today to talk a little bit about RECELL and how it's used in patient delivery of care.

Dr. Lisa Gold earned her MD and PhD in the Medical Scholars Program at the University of Illinois. She's been practicing plastic and reconstructive surgery with an emphasis on difficult wound problems since 1999. She's an affiliate professor in the Department of Molecular Pharmacology and Physiology at the University of South Florida, and is clinical associate professor of medicine at Brown University. She brings with her an amazing passion for research and education and wound care, and she currently works at the South Shore Hospital and South Shore Health Center for Wound Healing in Weymouth, Massachusetts, and is part of national organizations that serve many different areas, including the Wound Healing Society and the Alliance for Wound Care Stakeholders and the National Pressure Injury Advisory Panel, additionally with the American College of Surgeons. She's the past president of the Wound Healing Society, and she's served on the executive board for more than 10 years and is the recipient of Distinguished Service Award. We're also incredibly excited to announce that she's this year's 2024 Lifetime Achievement Award winner here at SAWC. Welcome, and thanks for joining us today.

Dr. Lisa Gould, MD, PhD, FACS:
Thank you Brad. I'm happy to be here.

Wiggins:
We're excited to have you. We're going to jump out there and talk a little bit about RECELL spray-on skin cells and use some patient delivery of care. Can you tell us a little bit about RECELL and how you use it in your clinical delivery?

Dr. Gould:
Sure, so RECELL is actually, it's a device, but it's really a technique. And it's a way to provide skin cells with less donor site. So, we see in the first slide that we can really reduce the donor skin by using RECELL with a widely meshed graft and spraying over the tissue. On one side, you see a traditional graft that's done one to one and that certainly heals, but it heals just as well if the widely meshed graft is then over sprayed with the single cell suspension.

Wiggins:
Great. I'm glad that you found that very useful in your patient delivery of care. Can you talk a little bit about the clinical advantages that you found and how that translates into cost savings? Seems like an interesting comment to make, but we know that obviously skin grafting can be a very comprehensive process. How's it impacting your patients’ cost savings?

Dr. Gould:
Right, so if you look at the history, RECELL was originally developed by Fiona Wood and her scientists in Australia, where they had a clinical problem with large body surface area burns. And so the donor sites in those are really dramatically painful and slow to heal. And to be able to save donor site and still get healing in a shorter period of time was a dramatic improvement.

So, originally, if you look at the burn literature, by reducing the length of stay is really where the cost reduction comes in. You can get things healed faster, but you're also cutting length of stay. And that's really important in our current hospital situation where we have overburdened hospitals, and we need to get patients out quickly. So for nonthermal, full-thickness wounds, I can help people get healed quicker and get them out of the hospital and back to their lives. And that is not only a cost saving, but it's important for the patient.

Wiggins:
That's great news. We love seeing that. I think the other thing that we've noticed is that with RECELL, it really impacts the reconstructive ladder for delivery of care with patients. What are your considerations and thoughts about using spray-on skin cells for the reconstructive ladder?

Dr. Gould:
Right, so the reconstructive ladder, I always draw a ladder itself, and in plastic surgery we start on the bottom rung with the simplest, which is to either let it heal secondarily or do primary closure, and then you work up and a skin graft is just underneath the more complex flaps and free tissue transfer that we do. But as we look at it, you cannot do that without a well-prepared matrix. And so that's where RECELL fits in, is it's simpler than the meshed graft, because we're taking less donor site but also helping with the matrix that is helping to heal and give us a long-term outcome.

Wiggins:
That's great. When you think about skin grafting someone or putting an autograft on someone, what are some of the limitations that are faced?

Dr. Gould:
Yeah, so my patients are mostly older adults and many are immune-compromised. And then I also have a pretty substantial number of patients who have pain issues. And so to be able to reduce that pain and get them healed quicker without a large donor site that takes a long time to heal is a big advantage. In the burn world, of course, there's very large surface area burns. There's lack of donor site availability, and particularly in pediatrics, and then just the cosmesis. So, when you think about taking a large skin graft off of someone's thigh, it can be really disruptive to their life, especially if they're young and they anticipate going outside in the sun a lot.

Wiggins:
Sure. You mentioned that a lot of your patients have come from a kind of an older generation. Are there differences in care delivery when it comes to considerations for skin grafting in an elderly person?

Dr. Gould:
I have shown that in the elderly person, say over 80, is pretty common for me to be taking care of. Their donor sites heal, but many of them are also on anticoagulation, and so they ooze a lot, and so with the RECELL process they have less oozing because we're taking a much thinner donor site and a smaller donor site.

Wiggins:
That's great news. So would you mind explaining the RECELL system to the audience, and I think people probably aren't very familiar with it within the wound world. It's been very prevalent across the burn community, but how does it work?

Dr. Gould:
So, it's basically taking a very, very thin split-thickness graft and then taking part of that, if you're treating a full-thickness wound, taking part of that and expanding it by making a single-cell suspension. And then you can actually deliver it at 1:80, so we're really expanding it a lot. So, a 1-square-centimeter piece of skin can cover 80 square centimeters, but for full-thickness wounds, we're combining that with a widely meshed graft and overspraying. So, still doing a split-thickness skin graft, but it's much thinner and then overspraying on that and delivering it.

Wiggins:
I think that really highlights the donor-sparing impact that you can have with using this type of process, so that's really great news. How long does it take to prepare in the operating room?

Dr. Gould:
It takes about 30 minutes, and when done as a team, we can really get things done fast, and so I optimize the time in the operating room, because that's another cost, and by me knowing the size of the graft to take originally, marking that out, getting the skin, and then having either my PA or one of the nurses in the operating room preparing the skin while I'm also working on the wound itself to get it ready, we cut down the time.

Wiggins:
That's great, just having this as a point of care inside the operating room really has been a fantastic opportunity for patient delivery of care, so I'm glad that's worked well.

Dr. Gould:
Right, and I think that's what we need to emphasize, is that we're not sending skin off to be grown in a lab and coming back, this is all done in the operating room point of care.

Wiggins:
Wonderful, I think that makes a huge difference. What are some of the key things that are important for using RECELL on a patient? What have you found to be the most important step?

Dr. Gould:
Getting the wound bed prepared. So, in the burn literature, early excision and grafting is obviously the way to best take care of those wounds. And I feel the same way about the wounds that I treat, the necrotizing infections, the fasciotomies, getting those wounds excised, eliminating the necrotic tissue, and then getting a good, clean, healthy bed. But then also bringing that wound up to a granulating bed that you know will take a graft is so important. You cannot graft over fascia. You can't graft on bone. That has to be vascularized.

Wiggins:
I would guess those are a lot of types of patients that you see where they're looking for you to promote the wound bed a little bit.

Dr. Gould:
It is. And when there are exposed structures, I use a matrix in order to facilitate and promote that healing or negative pressure or both. And it's a judgment call as to when to do the graft, but we're used to looking at it, and it needs to be well-prepared, and then you get excellent outcomes with a well-prepared bed.

Wiggins:
So, we have some examples here, talking a little bit about wound prep. Can you walk us through some of these?

Dr. Gould:
Right. So, if you look at the one that's before excision, you can see that some of the tissue doesn't look healthy, and clearly muscle is exposed. This is a big bed wound, and so this needs to be done in the operating room, clean it up, and even after excision on the photo on the right, there is still some exposed fascia, so I would do topical wound healing for a while to get that prepared, because a graft will not take over that site.

Wiggins:
Great. Very important. What about this example?

Dr. Gould:
And this is another one. If someone tried to graft on the left, it just wouldn't take. And I think that's one of the most important things across the board, whether people are using other products to get a wound healed, it has to be a well-prepared bed.

Wiggins:
Great, I think in general, the summary of that is, if the wound bed is ready, like when the wound bed's ready, it's ready for a skin graft, right? That's when to use RECELL.

Dr. Gould:
Correct, and people would say, well, why not just let that secondarily heal, but a wound this size is going to take months and run the risk of getting infected.

Wiggins:
We have one last example here of a wound bed. This is also a more extensive one. What are your comments about this one?

Dr. Gould:
Again, you have before excision, there's obviously dead tissue, and knowing when to excise is also important, because there may be some demarcation that goes on. So, following that wound, you can do several excisions, but making sure that it's fully demarcated. And then, when you have exposed structures, doing topical wound care in order to fill in that wound bed and get something that's healthy, that it's going to be long-lasting for the patient and with better cosmesis.

Wiggins:
Yeah, and I think this is an example of one that could take many weeks to be able to generate a good wound bed.

Dr. Gould:
It may, and that's why I use another dermal matrix in order to promote that; it decreases the pain, too.

Wiggins:
Can you walk me through the steps in the operating rooms a little bit more specifically? So, you talked about it being a point of care device, we talked about kind of managing it and taking about 30 minutes. What are the steps?

Dr. Gould:
So, one of the big differences with the RECELL system is obtaining a very thin split-thickness skin graft, and many of us aren't used to that, and part of the reason donor sites take long to heal is because we take it at 0.012, 0.015 inches depth, and it's not an exact science, but we take a thin split-thickness skin graft, 0.006, 0.008. So, you can see through it, and it makes us nervous. It's like paper thin, but then, so what I do is I measure the wound first, and then I outline, I do the math in my head of how much of a widely meshed graft I'm going to take, and then how much I'm going to need for the spray-on cells. I mark that out on the donor site, and then harvest the graft with a dermatome. And then my sous-chef prepares it with the RECELL device, the system.

And so, it's a process of an enzymatic debridement or enzymatic suspension, and then scraping it, which we'll see in another slide, and then just processing it so that it's a single-cell suspension. And then, in the meantime, I'm laying on the widely meshed graft and securing that so that when it's time to spray, we're ready to go.

Wiggins:
That's great. This is an example of the preparation on the device. What's this look like for you? Like you said that a lot of times you're still working with the patient, so this is happening on the back table?

Dr. Gould:
It's on the back table with the device, and it's really easy but the enzymatic digestion first you just put the skin in and then take it out and it's really soft and scraping that skin until it gets into little tiny pieces and then putting it into buffer and kind of mulling it about so that you know that you've really got a single cell suspension, and there's a filtering process, and then suck it up in a syringe.

Wiggins:
So, yeah, we have a great little video here that's been sped up to understand and explain. So, this is after you've soaked the piece of skin from the patient. And then you're simply creating a slurry of skin cells, it looks like.

Dr. Gould:
It is, you can't tell that it's single cells, and at that point it's really not, it's just mushed up skin, but then when it goes through the processing with the filtering, then you can really see that it's single cells in solution.

Wiggins:
That's great. So once it's prepared and processed, you get to the delivery phase.

Dr. Gould:
Right.

Wiggins:
Is this the fun part? Or is it kind of the anticlimactic part?

Dr. Gould:
No, no, it's fun, but it was a little bit of a learning curve, because when we think of spraying on, we're used to pressing on the nozzle, and instead you're pushing up, but it's going through the spray. And if you do it too slow, it just drips. If you do it too fast, it goes everywhere. So yeah, there's a learning curve to it.

Wiggins:
Do you worry about excess spray anywhere, or does it just really attach itself well to the wound?

Dr. Gould:
You can't see it, you have to believe, but we put the dressing on first so that we catch the drips, and then we can put it back over the wound if we need to. Most of my patients, it's not going to be a flat surface, it's a round surface. And it sticks, but we do position it so that we have most of it on a flat surface.

Wiggins:
Okay, great. We've had a couple of different videos here to demonstrate both treatment in full-thickness wounds as well as in a deep partial-thickness injury as well. Have you treated both?

Dr. Gould:
I have, and we'll show one of my patients that was a partial-thickness wound, and we'll see that in a bit.

Wiggins:
So, a lot of people obviously in particularly here at SAWC, might be very interested in the wound wrapping part, right? How do you actually do dressings for RECELL? Is it a special treatment? Are you doing anything different than you might do with your other patients? Can you tell us a little bit about how you prepare it after?

Dr. Gould:
It's pretty similar to what I've always done, but there is a clear dressing that has pores in it that's it's almost like saran wrap, and again you have to believe that it has pores in it, but you can cover the graft with that and then put a secondary dressing, which is like a nonadherent dressing, and then gauze and an outer wrap, and I'm doing a lot of lower extremity wounds, so I'm putting most my patients in compression, and that helps. The nice thing about the RECELL is you don't necessarily need a bolster, but you still need to hold it still but the single cells aren't going to move around, so I put my patients in a compression with the outer dressing, and then they can go home after that usually.

Wiggins:
Yeah, I think you might touch on this in one of your cases later here in a few minutes on a few more slides, but what if you have a patient where you want to send them out with a wound vac? Can you use a wound vac with RECELL?

Dr. Gould:
Yeah, you can use a wound vac with most grafts, so you still use a nonadherent dressing, and then you can put negative pressure wound therapy over that, and it acts as the bolster. It will also manage some of the exudate, so if the wound has excess exudate you can still graft.

Wiggins:
Great. Do you have a preference for black foam over the white foam with your treatment of when you go to use that?

Dr. Gould:
I always use black foam.

Wiggins:
Okay, great. So, this slide actually depicts a little bit about the regeneration process. Can you explain what's going on in these slides and why it's important?

Dr. Gould:
Yeah, so if you think about it, a full-thickness wound heals from the edges in, whereas a partial thickness wound, if you still have hair follicles, you can heal from those hair follicles and heal out. So, if we're looking at full-thickness wounds, a deep partial-thickness burn or full-thickness wound, and we put a widely meshed graft on that, those little holes still have to heal secondarily. And so the advantage with the RECELL is we're filling those holes with a single-cell suspension. So, now you're healing those much quicker.

Wiggins:
What are the cells made up of? Once create the slurry; what are you spraying on?

Dr. Gould:
Right, so it's as I said, it's a very thin split-thickness graft, so it's mostly keratinocytes, but there's still some fibroblasts in there, and there's also the melanocytes that are in there that can help with repigmentation.

Wiggins:
This is a cellular layer kind of looking exam and kind of on a microscopic level to understand the difference between the split-thickness skin graft and the interstices. What do you see here as a scientist?

Dr. Gould:
This is a scary part for a clinician, but also as a scientist. So, this is a pig model where they heal pretty quickly, but you will see that re-epithelialization microscopically in 3 days. But you can't see it with your eyes. Until you get that more mature epithelium, you do not see it, and you have to believe.

Wiggins:
You have to believe that it's going to be there. So, that was something you experienced. That's great. So, we have your first clinical case here. Can you tell us a little bit about this case?

Dr. Gould:
Right, so this was a patient with class 1 obesity, COPD, and a necrotizing infection, and continued to have heavy drainage. And it's a wound that is so hard to immobilize that I knew that a really typical split-thickness skin graft would not take. So, we did the RECELL process using the widely meshed graft. And I did secure that with negative pressure. But we could only keep the negative pressure working while he was in the hospital, because every movement disrupts it. And so when I sent him home, I sent him home without the negative pressure. And he bounced back to the hospital with excess drainage. And you can see in that second picture, it doesn't even look like there's a graft there. And I was very disappointed. But 10 days later, I started to see it, and I start to see it in the interstices. The widely meshed graft itself pretty much ghosted away, but you can see it start to fill in over time. And at 7 weeks, he was healed, didn't need a dressing. And then at 9 weeks, he's got some contraction because he did heal a little bit by secondary intention, but it was healed. It was healed in 7 weeks, and his donor site, which was pretty small compared to the size of the wound itself, healed in 13 days.

Wiggins:
Definitive closure really becomes the name of the game when you're using autologous spray-on skin cells. I think that's what you would want to see.

Dr. Gould:
And in a groin wound where it's very difficult to secure it, the patients are so thankful to have this thing healed.

Wiggins:
That's great. We have some really important things to report as far as what clinical safety and efficacy looks like within the use of RECELL. Can you highlight a little bit about the RCTs that have been done?

Dr. Gould:
So, the original RCTs were in burns, which is what we would expect, and then both partial-thickness and mixed-depth burns, so 2 large RCTs there, but then also an RCT in the full-thickness skin defects, which, so you have 3 for wounds alone, which they're robust randomized clinical trials that have been published, and also now an RCT in vitiligo, which is a partial-thickness wound, but we're looking primarily in those at the repigmentation. And so that's a really interesting program.

Wiggins:
That's great. To be able to have use both in burn delivery of care, in full-thickness skin defect, soft tissue injury type of injuries, vitiligo injuries, as well as the opportunity to really demonstrate cost savings and length of stay reduction are really big game changers for this use.

Dr. Gould:
Yeah, I think that that is a big game changer. And the other thing that people need to know is it's usually a single application, it's not week after week, it's 1 single application, maybe a second application if things really slow down.

Wiggins:
That’s great. So, some of the indications for use are both in partial-thickness and full-thickness injuries we've covered a lot of that, is there anything else that's important understand?

Dr. Gould:
I think it's learning that that widely meshed graft can still work, because we're not used to meshing them, unless people have done burn and they really have limited donor sites, we're not used to that, and you can really spread it out and then overspray it.

Wiggins:
Glad to be able to see that. We have an additional case study of you that I just think is fascinating. Can you tell us a little bit about this one and why it was such an important case for you?

Dr. Gould:
Yeah, this was exciting because this was my first patient that I used RECELL with. And she has end-stage renal disease, on dialysis, and had previously had calciphylaxis, which is why I knew her. I treated her calciphylaxis and got her healed. And then she ran into the corner of her bed and got a very large hematoma and didn't know at the time that her platelets were at 50,000.

Wiggins:
Oh, wow.

Dr. Gould:
So, we evacuated the hematoma, hoping to be able to save the skin, but it went on to necrose, and so I had this large wound in someone that has very high morbidity and decided that I would use RECELL on that. Now, in this case, it really was most likely a partial-thickness wound. You know, we're not doing biopsies and looking microscopically to know that, but because the hematoma was subepidermal, it is a partial-thickness wound.

So, we did spray only on her, because I really wanted to keep the donor site to a minimum. And it's a 262-square-centimeter wound. And in 11 weeks, she was completely healed, which in a patient like her is not bad. And then in 4 months, the result is dramatic. It's pliable, it's durable, and she's just thrilled, and the donor site was only 8 square centimeters for a 262-square-centimeter wound.

Wiggins:
It's wonderful that you are able to demonstrate definitive wound closure in something so comprehensive and on a patient that had a lot of comorbidities. What are some of the aftercare things that you've noticed about when treating with RECELL?

Dr. Gould:
So, again because I treat a lot of lower extremity wounds, I will put them in compression, so they can get up and mobilize as soon as possible. I'm not keeping them in the hospital. I'm not keeping them in bed. If they're in the hospital because they have some other condition, we can get PT and OT working with them right away. The compression that I use prevents shearing, so you do need to keep that graft in place with the wound. And some of it is exudate management as well. I'm learning that I can graft wounds that are more heavily draining than I normally would, but then I do need to manage the exudate that way. And that's why I use compression garments and sometimes the negative pressure.

Obviously for all wound healing, we're promoting nutrition, managing pain, but the pain is much less anyway, because the donor side is so thin. And then educating not only patient and family but the nurses who may be taking care of this afterwards, because they don't know what's under the dressing, and I don't want them to disturb it.

Wiggins:
Sure, I think all those things are very important. RECELL has established a lot and AVITA Medical have established a lot of reimbursement criteria for the treatment of autologous spray-on skin cells on patients. Can you tell us a little bit about how that's impacted your patients?

Dr. Gould:
Yeah, so it's covered, that's the most important thing. When coded appropriately, we know what the ICD -10 codes are for the wound, and it's usually most of what I'm doing right now are necrotizing infection wounds or fasciotomies, so they're subacute, because I need to get them to that point, but there's codes for that, and then the coverage is both as an epidermal graft and also the typical split-thickness autografting.

Wiggins:
Does AVITA have support for you when it comes to reimbursement?

Dr. Gould:
Oh yeah, you know, it's a learning process, right? And AVITA is very familiar with how to do that. And then they're also following up on the back end with our coders and our billers and seeing that we're getting reimbursed.

Wiggins:
That's great. Additional support and things that are offered to you as a user of RECELL?

Dr. Gould:
So, I've been doing skin grafts for a long time, so it was pretty easy to adopt, but there are good clinical specialists. There's the Medical Science Liaison, the billing and coding support staff training. They can come to the clinic actually while I'm here. There will be AVITA support for the patient that I grafted last week to make sure that the nurses know what's under the dressing. I sometimes leave that clear dressing in place so that the graft doesn't get disturbed for a couple of weeks if they're not heavily draining. And I don't want the nurses to take it away.

Wiggins:
That's great. So, in closing up our conversation today, I think some of the things that should be highlighted are some pretty important pieces. Do you mind sharing those with our audience today?

Dr. Gould:
Right. So, I think you know that the big change is in donor site size and donor site recovery. It's a big part of it. And why people are afraid of skin grafting is because everyone thinks that the donor sites are so awful. And we can show, I can heal them in 10 to 12 days. The outcomes are great. We get patients out of the hospital quicker and we're reducing costs, which the hospital loves. And then we have the support from the staff and a really, really knowledgeable group of nurse reps who come and help with it.

Wiggins:
Fantastic. Well, we appreciate your time today, and thanks for joining us here at SAWC to talk about the impact of RECELL and autologous spray-on skin cells on patient delivery of care. I feel like your cases have really highlighted the outstanding opportunity there is for wound closure, and we really appreciate you taking the time today to join us here, so thank you. Thank you so much for joining us today.