Examining the Role of dHACA in Surgical Wounds

Sponsored by MTF Biologics

To review the full paper in the International Wound Journal by Tacktill and colleagues, please click here. 

Jeremy Christensen, DPM:

I'm Dr. Cade Christensen. I practice out of Castle Rock, Colorado, which is a suburb of Denver, just for about 15 years now. Did my undergrad work at Brigham Young University in Provo, Utah. Attended the California College of Podiatric Medicine in San Francisco, California. Ended up doing residency here in Denver, Colorado at the Highlands PSL Surgical Residency Program. I am a fellow of the American College of Foot and Ankle Surgeons and double board certified by the American Board of Foot and Ankle Surgeons as well.

So I just wanted to briefly discuss the Tacktill article entitled, "Wound Repair Safety and Functional Outcomes in Reconstructive Lower Extremity Foot and Ankle Surgery using a Dehydrated Amnion/Chorion Allograft Membrane." Again, this was published in March of this year in the International Wound Journal. A single surgeon study, 21 patients of retrospective design where they were trying to examine the outcomes, the functional outcomes, utilizing AOFAS scoring for utilizing the dehydrated human amnion/chorion allograft tissue for more of a functional outcome and reconstructive processes.

Amnion and chorion has been used as placental grafts are probably over a century, a lot in wound healing. Kind of over the past 10 years, diabetic foot wounds has kind of become a mainstay for treatments for that. Again, this study specifically looks at utilizing the tissue for functional outcomes utilizing AOFAS scoring. AOFAS stands for the American Orthopedic Foot and Ankle Society scoring. It's a well-validated method in assessing surgical outcomes.

What they found in this paper, and again it was a variety of types of cases. Of the 21 cases, I believe 11 of them were kind of classified in the subgroup of ankle, hindfoot, rear foot. Eight of them were midfoot subgroup, and then two of them were on the hallux. So they went back and kind of retrospectively reviewed the outcomes. The hypothesis here was they were going to see the same effects that we see from amnion in wound care applications, including less inflammation, neovascularization, a good cell support structure to allow these surgeries to heal out faster and provide the patient with a quicker return to function or a better outcome. And that's exactly what they found in this paper.

The AOFAS scores drastically improved in all of their cases. They did not suffer any infections, wound dehiscence, et cetera, and really had very favorable results utilizing the MTF product. Again, and they applied the tissue kind of directly over the deeper layers which is kind of in contrast to what we see in the wound care world where we're kind of utilizing this more superficially in some of the wounds. And again, this tissue was utilized deeper prior to subcuticular closure or in the process of closing that layer. And again, the authors were able to observe what they anticipated, which was the less inflammation, the less dehiscence, less incisional line, necrosis, et cetera.

Typically, many of the patients in this study did have a wide variety of comorbidities, including rheumatoid arthritis, diabetes, known factors, known comorbidities to increase the chances of having surgical complications, including wound complications. And again, even with those comorbidities, they were able to see by utilizing the MTF product, the amnion/chorion layer that they were able to really avoid a lot of these type of complications that are seen frequently.

Many studies will quote these typically are like in the mid-teens to high teens rates of incisional complications with some of these complicated reconstructive cases. So again, here in a little while I'd like to share a few of my cases as well where I've experienced the same findings that they've found in this paper. I was happy to learn of this paper and to know of this paper because again, I've been using the MTF tissue and that portfolio very similarly to the way they have been utilizing it. And again, I've encountered many of the same results.

Again, amnion has great properties in that it is anti-adhesive, anti-scarring. It supports cell structure. It allows for neovascularization in the wound. And again, similar to the way this tissue's been utilized in diabetic foot wounds, again, we're just utilizing it in a surgically created wound. And fortunately we are able to receive those same benefits of using the tissue. And we can kind of go through a few of my cases where again, I've been able to experience the same findings that they've had in the tactile paper and wanted to kind of discuss those here today.

I'd like to start with a 33-year-old male, a member of the army. He came in with a really a chief complaint of a swollen ankle. Kind of said his pain level was more of a five out of 10. I think for the rest of us that would probably be a little bit higher, kind of a tough guy. He noticed a little bit of swelling. I mean kind of hit a peak when he was returning home from a road trip from Arizona.

So we took some x-rays of his foot and ankle, didn't really see a whole lot, maybe a little bit of arthritic change noted on that lateral view around the ankle. Still having pain, didn't really kind of fully explain why he was having the level of pain that he was and the disability and chronic swelling that he was. We did opt to go ahead and order a CT scan, which did reveal some pretty significant change and collapse of that medial talar shoulder with loose body.

We came up with a surgical plan that we would kind of go in. I felt that the level of damage here at this point was probably beyond just kind of a scope and microfracture and we opted to go ahead and perform a talar shoulder block replacement in this instance. Knowing that again and very honest with the patient that this may not be his last surgery, but we wanted to provide him with something. We would try to get as much mileage out of this ankle that we could prior to him possibly requiring an ankle fusion or an ankle joint arthroplasty at some point in the future.

So we did plan to go in and kind of do a medial malleolar take down so we would have access to that medial talar shoulder. As you can see here, the patient did have some significant arthritic change with loose bodies and collapse of that medial talar shoulder. Through this approach, we had pretty good visualization of what we needed. Our friends at MTF were able to provide us with a talus for implantation. We were able to go ahead and kind of measure out and mark out the size of the lesion and correspond that with our grafting material here. Here you can see in these slides that we were able to go ahead and kind of custom fit that medial talar shoulder for this individual.

Here a quick comparison between the diseased portion of the patient's talus versus our grafting material that we'd placed. We were able to get a good solid press fit in there as you can kind of see in these views. We were able to kind of line up that ankle joint mortis very well. I opted to go ahead and utilize absorbable fixation in this instance so that it would not interfere with any additional surgeries that the patient may require in the future. So I was able to go ahead and kind of tack that piece in with some absorbable screws provided by another company. Again, just based on the level of surgery and the level of anticipated complication in this type of case, we have to go ahead and utilize the Salera mini membrane or the dehydrated amnion/chorion allograft.

This is kind of in a particulate form, and we were able to go ahead and place that deep in the layers of closure. Once we had placed the particulate layer deep, I did actually also use a membrane more superficially as you can see in these pictures here, and we used that prior to closure. Really, my main goal with this was to try to make sure that I could decrease adhesions in that area. And again, amnion is known for its anti-adhesion, anti-scarring properties. So that was my main goal in trying to support healing of this area. So I was able to use that tissue. Here you can kind of see a little bit more of a closeup of utilizing both the particulate form of the Salera or the membrane and then again, the full membrane prior to subcuticular closure here. And got a good closure for him and he went on to heal.

Here's some early post-operative films you can kind of see. Obviously we did fix medial malleolar take down utilizing two screws and again, we got a really good flush repair by doing the talar block replacement. Later post-op films, he went on to heal well. He was able to heal that medial malleolar take down well, and again, we got good integration of the implant, so we're very pleased with that. He is probably close to a year out at this point, doing very well, better than I even anticipated. So I think we got a good result on that one.

Another case I'd like to share, kind of an unfortunate situation for this gentleman. A 56-year-old male, again had been diagnosed with diabetes probably a few weeks prior to his presentation. He was exercising, as you can see, this was roughly a year ago, and this was in December of '21. He developed some changes in that foot after hearing a pop. He did go see his primary care doctor who introduced him to Charcot neuroarthropathy. Again, this was very new for him as he was a very recently diagnosed diabetic, type two, as well as again, someone who is suffering from Charcot changes.

And he did provide us with the emergency room films. Again, this is roughly a year ago. He had pain kind of in the midfoot area. The X-rays aren't super telling, but you can see there's a little bit of alignment change kind of at that navicular cuneiform area. And so we kind of kept an eye on that. He really came in, presented mostly with just swelling. He was having some pain, but it was mostly swelling that was causing him disability. About 10 days, well 10 days to two weeks later, he came in for preoperative planning and films. And you can see after repeating the X-rays, we have significant collapse of that talar navicular area, the navicular cuneiform joint. The navicular bone itself is actually kind of morphed and changed a little bit in its structure as well. And again, we've got progressive declination of that talus with the collapse of the midfoot.

So very commonly these patients will go on to have a rocker bottom foot type, and again, just an overall very unstable foot. So we plan to take him to surgery for fixation of this and we're able to kind of go in with surgical plan of coming through a medial approach so that we could go ahead and stabilize that medial column where he was experiencing the collapse. And we did check in for an equinus deformity, didn't necessarily have an equinus deformity, but we opted to go ahead and plan surgically for that medial column arthrodesis with kind of a planar plating technique. Again, in this case, we did have to use a fairly large incision, which again puts him at risk as a newly diagnosed diabetic. Again, so the decision was made to utilize the MTF portfolio in utilizing the dehydrated human amnion/chorion allograft to support this significant fusion and to try to decrease our possibilities of postoperative complications.

Here you can kind of see again a long medial approach. Centrally, you can kind of see the talar head there. We were able to go in and reef that up, restore some of that arch to try to prevent that progressive collapse, which is seen commonly in the Charcot foot. So again, in contrast to some of the wound care applications with amnion, here you can see I am utilizing the particular application directly over the hardware. Again, but we're trying to prevent adhesions in this area, try to promote that neovascularization, just kind of provide a scaffold and cell support for healing. A hundred sixty milligram is what I ended up utilizing directly over the hardware here in this situation as you can see in these photos. Also, we did place a membrane over the area as well. Again, I do like utilizing the particulate just for when I have large areas.

I'm able to kind of cover a larger area with the particulate versus a membrane. I was also able to place the membrane in that sub-particular closure. And again, we were able to really try to reapproximate this long medial incision as well. So immediate post-op films, I was pleased with the reconstruction and the alignment that we were able to achieve there, again, through a kind of long medial column, kind of a planar medial based plate. And he went on to heal this, he was able to heal that. We were able to avoid the wound complications. Unfortunately, this individual actually ended up developing problems on the contralateral foot during his recovery here and went on to have surgery on the contralateral side as well. So I was happy that we had a good stable right foot that he could utilize as he was recovering from required surgery on the left foot as well. But again, he healed very well utilizing the dehydrated human amnion/chorion tissue as well.

One last case I'd like to share. A 54-year-old female with a BMI. She did suffer an ankle sprain that she reported roughly eight months prior. She had been utilizing braces, compression, NSAIDs, and again her main complaint was that ankle was still swelling. She just wasn't getting that relief and she had a loss of function. Again, it made it very difficult for her to participate in her line of work. She came in, we got films again. Overall bone quality looked pretty good, alignment looked fairly good. Opted to go ahead and get an MRI because it seemed to be more of a soft tissue issue for her. The MRI did reveal a peroneus brevis tear with lateral ankle instability. Clinically, this did correspond with the types of issues she was having with the swelling and history of ankle sprains.

Our OR plan for her was to take her to the OR, do a peroneus brevis repair of brostrom lateral ankle stabilization as well. Again, this had been kind of a little bit of a delayed presentation. I know she had had the injury at least eight months prior. So again, you can see here we went in and opted to go ahead and perform a perineal tendon repair. She definitely had a longitudinal tear of that intrasubstance tear. Her main complaint was just, "Hey, watch out for my tattoo." But we were able to kind of avoid that or just on the very edge of that. Again, after repairing the tendon, we wanted something to kind of further reinforce that. Again, perineal tendon surgeries often fraught with complications, not only incisional healing, but again also with adhesion of that tendon to the tendon sheath or that tendon sheath to the surrounding areas.

So we opt to go ahead and wrap the perineal tendon with one of the amnio band membranes, which again, as we discussed earlier, is dehydrated human amnion/chorion membrane allograft. So we were able to go ahead and repair that as you can kind of see in these photos here, kind of almost like a burrito technique. In contrast to the previous cases where I had used the mini membrane or the Solera tissue deep op, I had utilize that more superficially because I had utilized an amnio band membrane deep directly around the tendon again. So I was able to kind of, prior to sub-particular closure, I was able to place the allograft in that area again to prevent any adhesion in this area, which is common with this type of surgery. So we're able to get a good result with that. Patient went on to do very, very well with that and was able to return to function.

Over time, her swelling did subside and she was able to return to a gainful employment, which was a victory for us. Again, postoperative films, we can see a couple little anchors distally from the brostrom, but again, overall maintained good alignment and a good functional outcome for her. So those are just a few of the cases that kind of show that I have experienced many of the same findings that the tactile paper has described. Again, the tissue has really kind of revolutionized the way I do surgery. Patients come in happier, they typically have less pain, there's less inflammation. I'm noticing less incisional necrosis along the incision lines, less scarring and less swelling, and just overall just better functional outcomes for these individuals. So I've been very pleased with my outcomes utilizing the MTF portfolio. And again, I think it reflects very closely with what is reported in the tactile paper.

I would say in the Tacktill paper, they were able to utilize some of the MTF portfolio, MTF standing from Musculoskeletal Transplant Foundation. They're based out of Edison, New Jersey. Again, they have a proprietary way of aseptically procuring and processing this tissue, and I think that kind of is what makes it stand out from other tissues. This tissue is not irradiated. So again, it's able to maintain its native estate and it again is utilized as a covering for surgical applications. Again, it's very well known what it has done in the wound healing space. But again, this paper kind of explores a little bit further, more of the reconstructive side of foot and ankle surgery and what we can do to kind of maximize the outcomes for individuals that need to have a quick return to function. So again, as mentioned in the paper, I've noticed that again with my patients as well, we've had much less inflammation, much less pain.

We've been able to see a quicker return to function. Incision lines just look a lot better even at that first post-op visit, which I normally like to see my patients back in about a week. I've been tempted at times to remove the sutures at that point just because it feels really like their healing has been kind of accelerated. Again, with less pain, we've had less need of utilizing narcotic pain medication, which has its own inherent risks with it as well. So again, much as they found in their paper, we found many of the same experiences doing kind of foot and ankle surgery in this realm as well. So thank you very much.