James McGuire, DPM
We talked to Dr McGuire about the evolution of the wound care market, his experiences with the 3C Patch® treatment – which he has used in his clinic since 2019 – and why he thinks 3C Patch® is different.
What do you consider to be the most important developments in wound care?
There is a greater focus on wound care in the medical profession, a trend accompanied by an exponential increase in the availability of advanced wound care products and wound treatment procedures. These developments are not surprising when you consider that in 2018 there were 8.2 million people with wounds in the US alone.
Two relatively new wound care product categories are on the rise:
- autologous wound care products and new technologies to create them.
- nanoparticles, nanofibers, artificial matrices, and 3D printing of biological structures to fill the wound cavity.
Very soon, I think we will have quick cellular analysis tools that enable PCR testing to identify the composition of a chronic wound and guide our treatment models.
Back in the late 1980s treating a wound by washing it with HOCl was considered radical. The treatment options we see today reflect increased understanding and interest in the science of wound healing and in reducing the socio-economic burden of chronic wounds.
How do you see autologous wound care products being adopted into clinical practice?
I think it will be very rapid. Regenerative medicine has definite advantages, especially products that require limited tissue donation with no side effects for the patient. For example, all you need to create a 3C Patch® is an 18ml blood sample once a week; that’s it.
I have no doubt that autologous products will push out xenografts over time. Given the choice between an animal-derived graft and a human autologous product, I’ll choose the human product every time. And if considering a human cadaver or placental tissue over a patients’ blood, which is whole and alive, and goes straight back on, I would go with the whole blood product almost every time. This is mainly because autologous products stimulate the body with growth factors and will not be rejected.
How do you select the right wound treatment for a new patient?
When a patient comes in the clinic for the first time, we do a full evaluation:
- historical evaluation and assessment;
- wound bed assessment, including the bioburden in the wound;
- depth of the wound
- full circulatory assessment,
- characteristics of the wound: the amount of fluid, periwound skin assessment,
- social-spiritual assessment: attitude towards wounds, resources available (social support to help with wound dressings and the affordability of the dressings)
I lean towards autologous products, as they have proven to be very effective in my experience. Other factors should also be considered including the amount and type of tissue that needs to be collected, additional paperwork involved, whether we need to ship it and wait for the finished product, etc.
I am not particularly a fan of advanced wound care products with very limited time frames for application, that require thawing, or anything that needs to come by mail and may not make it. With these types of wound care products, if the patient misses their appointment for some reason, then a $1000 piece of material – for example – will go to waste. That’s why I prefer a product that I can make and apply to the wound when the patient enters the clinic.
What differentiates 3C Patch® from other advanced wound care products?
There are three main characteristics of advanced wound care treatments that I consider extremely important for wound healing – that they are autologous, have living cells, and can be prepared on-site. 3C Patch® has them all.
There are only a handful of cellular and tissue-based products with living cells, and of those, only very few are autologous and even fewer can be prepared on-site.
The 3C Patch® contains a higher level of growth factors than other products on the market, along with other signaling molecules. When placed on the wound, it actually “tells” the marginal cells that there is a healthy environment, filled with platelets and leukocytes and you can see the edges migrating faster. You start seeing granulation tissue forming quicker, usually after 2-3 applications.
Furthermore, 3C Patch® works as a stand-alone product for diabetic foot ulcers and is the only one recommended by the International Working Group on Diabetic Foot (IWGDF, 2019), based on the clinical evidence available.
How would you describe your experience with 3C Patch®?
Helpfully, 3C Patch® is classified as a procedure – draw the blood, make the patch, put it on the wound – and when it comes to reimbursement, procedures are always preferable to non-procedures. They tend to get approved and paid better and more easily.
Our clinic is an outpatient chronic wound referral centre and most of the wounds we see are at least four weeks old and tend to be covered with biofilm, which complicates the healing process further. Even so, in our patient population, 3C Patch® has been seen to help move the wound from a “stalled” phase back to active healing.
Our patients are most 50-60 years plus, with poorly controlled diabetes (HBA1c ≥7) and associated complications and comorbidities including kidney disease, connective tissue disorders, nutritional challenges, etc. They are often not the best at following directions around dressing changes at home, coming on time, wearing their offloading devices, etc. All this means that having a point of care, regenerative treatment that can stimulate wound healing in this patient population is advantageous.
Can you tell us about implementing 3C Patch® into the clinic’s workflow?
We have implemented it in our clinic by optimizing the process as much as possible. The nurse takes the patient’s blood on arrival, puts the sample in the centrifuge, and starts the automated process to produce the 3C Patch®. While this is happening, on the first visit I do a thorough debridement and if it’s a follow-up visit and debridement is not necessary, I use this time to see other patients.
After the centrifugation process is finished, I come back and apply the 3C Patch® and the patient is ready to go home. With 3C Patch®, I’ve noticed that in most cases, when the patient comes back for the next appointment, the wound shows signs of improvement.
What types of wounds are suitable for 3C Patch® applications?
Technically, 3C Patch® shouldn’t be limited to any wound type because it’s the body’s own growth factors and works on any wound. It would work on an acute wound as well because the 3C Patch® will ramp up the activity in the acute wound healing process.
I’ve used 3C Patch® with good results on diabetic foot ulcers, a lateral pressure ulcer complicated by venous disease, a wound after incision dehiscence following surgery for an Achille’s tendon rupture, lateral ankle foot ulcers on both legs, a diabetic foot ulcer after 2nd Metatarsal Head resection for osteomyelitis, and an acute wound after excision of a large pyogenic granuloma in type I diabetes.
In what situations would you not use 3C Patch®?
Sometimes there are logistical issues, for example it is difficult to take blood from some patients or they have a needle phobia. In some of these cases, we choose the next best thing.
If the wound is healing at a regular rate and the basic good wound care works, there’s no need to do anything additional. However, another instance where I choose not to use 3C Patch® is when the patient refuses to comply with basic care, and I know that almost anything I put on the wound will go to waste. Right now, I have a patient with serious offloading issues, and anything we put on there, she stomps on it. In these cases, I’m reluctant to waste a good product on someone who’s not willing to follow the basic wound care guidelines.
Can you describe a treatment session with 3C Patch®?
We start by educating the patient about the treatment process explaining “We’re going to take your blood, we’ll concentrate it, and we’ll use a portion of it to heal your wound. So we’re trying to ramp up your body’s own ability to heal you.”
With 3C Patch® being a bed-side procedure, the patients can see that it’s only their blood that is being placed in the centrifuge. They can also see the patch being taken out of the device, and they understand that their blood was transformed into this small but concentrated construct that will help their wound heal.
After the centrifugation process is finished, we take the patch out of the device, apply it to the wound and steristrip it down, then add a non-adhesive dressing and a secondary dressing based according to the exudate levels. We prefer a secondary dressing with a silicone interface, so we don’t pull the patch off when it is changed. We also use a periwound protector and try to keep the wound moist.
We discharge the patient home with either home care nursing or written instructions, and we order them dressings through one of the dressing suppliers. If the wound is complicated, we see the patient initially biweekly, and then we switch to once-a-week applications.