Impressions of the pioneer users

Interview with Dr Bernd Hartmann, Berlin: “The Product Properties of SUPRATHEL® Were and Are Convincing”

Dr. Bernd Hartmann, Director of the Center for Severe Burn Injuries with Plastic Surgery in Berlin, is an early user of SUPRATHEL®. He outlines in this interview the indications for which SUPRATHEL® has been consistently used in his unit for 20 years and why the alloplastic material is as relevant as ever.

How long have you worked in the area of medical treatment of burns?

I have worked in this area since the 1990s. In 2000 I relocated to Berlin and the Accident Clinic, where I have since been Director of the Center for Severe Burn Injuries with Plastic Surgery.

You have been a SUPRATHEL® user from the very beginning. When and how did you first come into contact with SUPRATHEL® or today’s PolyMedics?

The contact came about via the Marienhospital in Stuttgart. Dr. Christian Uhlig, Director of the Center for Severe Burn Injuries there at the time, approached us. Stuttgart needed larger-scale studies of SUPRATHEL® with more cases, the aim being CE approval of the product. That was why the Stuttgart colleagues approached us. It is standard practice for the purpose of completing an approval study within the desired time frame.

What was your initial reaction when you heard about the product?

With a study of that kind we always first keep an open mind. You test, you compare. The idea of synthetic products made of polylactide was already going the rounds. The BMUZ, the PMI’s predecessor, was doing a lot of work in this area. What made it attractive was the fact that the material no longer had to be removed. Dr. Helmut Hierlemann was in charge of research on the continuous membrane, the “sponge tissue.” The material was supposed to seal the wound externally, leaving it to heal underneath. That was what was to be tested.

Were other products around that worked on the basis of a similar concept?

There were, of course, treatment concepts and care protocols for epidermis damaged by burn injuries. They used pigskin, for example, or a nylon net and collagen. The use of biological material is never free of a certain risk, however. Infections or allergies can always occur and diseases can be transmitted. A synthetic product does not harbor these risks. When the wound is deep—a third-degree burn—collagen products are standard to this day, although here too the trend is toward synthetics.

It is important to note at this point that the aim is not to replace the skin, but to reproduce the properties of human skin as comprehensively as possible.

What made the penny drop for you where SUPRATHEL®was concerned? When did you realize that SUPRATHEL® had the potential to revolutionize the treatment of burns?

We noticed in the very first trials that it worked. It was clear that the patients were in much less pain. SUPRATHEL® provides reasonable cover for 2a burns and sometimes for 2b too. We now treat everything that offers a prognosis of spontaneous healing with SUPRATHEL®.

A major advantage of SUPRATHEL® was that it is a synthetic upper skin replacement and not a dressing. That may at first sound like splitting hairs, but it had tangible consequences. It placed it in the category of transplantation and thereby in the correct relationship to the medical performance.

Prof. Dr. Heinrich Planck told me that the Marienhospital in Stuttgart aborted an approval study because it could no longer justify treating patients conventionally. Did you feel that way too?

No, we weren’t that drastic. We treated and evaluated the cases requested and were able to demonstrate that SUPRATHEL® had proven itself in the conditions required by the study. Once the study was concluded we continued to use it. The standard indications for SUPRATHEL® include scalding, from which children often suffer. In these cases, our experiences have been very good. Dressings do not have to be changed and children are in significantly less pain.

Was there a certain moment, a special occasion, when you were especially happy to have SUPRATHEL® at the ready?

Not really. We consider it to be a fundamentally useful product. We are happy to have it, especially for children.

Twenty years is a long time for a medical product. Why is SUPRATHEL® still relevant today?

SUPRATHEL®‘s product properties are convincing. Nothing to replace it is needed. Nothing with better properties has been found over the years. It still has a clear place in treatment.

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Interview with Dr Herbert Haller of Linz about SUPRATHEL®: “The Product that Made Three Dressing Changes a Day Obsolete Overnight”

Dr. Herbert Haller, now retired but for many years a senior physician at the Unfallkrankenhaus Accident Clinic in Linz, Austria, and director of its Burns Center, was one of SUPRATHEL®‘s first users. He describes how quickly SUPRATHEL® threw existing treatment concepts overboard and how SUPRATHEL® kickstarted a revolution in the treatment of burns.

How long did you work in the area of burns medicine?

I began my career in burns medicine in 1982, ending in 2017, and working mainly at the Accident Clinic (Unfallkrankenhaus) in Linz. From 1997 to 2000 I was in Berlin at the invitation of the Berlin Accident Clinic to set up a Burns Center there that is now the largest facility of its kind in Germany.

When and how did you first come into contact with SUPRATHEL® and today’s PolyMedics Innovations?

I heard lectures about it during the product’s development. Dr. Matthias Rapp of the Marienhospital in Stuttgart reported on his experiences. He, like me, is a trauma surgeon and we began at an early stage to exchange views on the subject even before SUPRATHEL® was in clinical use. We undertook our first trials in 2002 and I have documented my experiences with photographs since 2004.

Back then, PMI was a small institute where my contacts were Prof. Dr. Heinrich Planck and Dr. Helmut Hierlemann, who was in charge of developing the product as a chemist.

What was your first reaction when you heard about the product?

“It achieves something, saves work and speeds up the healing process,” my colleague Matthias Rapp said. They had already treated the first patients with SUPRATHEL® at the Marienhospital in Stuttgart, so I was curious and trialed SUPRATHEL® myself. My applications confirmed Dr. Rapp’s impression. The pain relief was plain to see. We were able to take patients off ventilation sooner with the result that we used fewer painkillers and patients stored less fluid and could be mobilized faster.

We quickly switched to using SUPRATHEL® and, if indicated, discontinued conventional treatment. In Linz we had only a small team, so the argument that using SUPRATHEL® reduced our workload was a decisive factor.

Were other products around that worked on the basis of a similar concept?

Yes, there were, and we tried out several of them, but no other product achieved the results that we saw SUPRATHEL® achieve.

What made the penny drop for you where SUPRATHEL® was concerned? When did you realize that SUPRATHEL® had the potential to revolutionize the treatment of burns?

I was convinced from the outset that SUPRATHEL® assisted the wound healing process. I used it in combination with other products, including what is now RECELL®. Its effect on the patient is highly positive. Compared with other methods, SUPRATHEL® promotes healing significantly. It also seals the wound from germs that penetrate from outside.

With burn victims, the high level of fluid loss has always been a major challenge. At the same time, however, fluid intake must not be exaggerated because that leads to the formation of edemas. Too large a water intake can often cause intestinal swelling, for example. Evaporative cooling is a further problem in this connection. If too much fluid is applied to wound surfaces the body cools down considerably.

SUPRATHEL® was able to regulate this fluid loss with all its consequences. It also relieves pain. That was particularly beneficial in the treatment of children, who previously had to be sedated with opiates before changing a dressing. And as SUPRATHEL® remains on the wound the number of dressing changes was reduced sharply.

Prof. Dr. Heinrich Planck told me that the Marienhospital in Stuttgart aborted an approval study because it could no longer justify treating patients conventionally. Did you feel that way too?

Yes, in Stuttgart the study was aborted before the required case number was achieved because treating wounds with SUPRATHEL® was significantly more effective than the alternatives. The results spoke for themselves. After treating only a few patients I also used SUPRATHEL® virtually across the board, first for burns on small areas and soon for deeper burns too. Over time it became clear that there was a place for SUPRATHEL® even to treat extensive deep burns right down to the fascia. It requires experience and conviction. When the dressing is changed a great deal of fluid is released to begin with. A very positive point is the fact that SUPRATHEL® does not need to be fixed and that the lactate released promotes early wound healing. The use of bank skin is a technique used to this day.

Was there a certain moment, a special occasion, when you were especially happy to have SUPRATHEL® at the ready?

I cannot recall a specific occasion. There were always serious cases, such as a fire victim of a tank explosion who had lost 60% of his skin and suffered from carbon monoxide poisoning. He was treated successfully and that was definitely due in part to SUPRATHEL®.

How did collaboration with PMI progress?

PMI was initially a small family firm with limited means at its disposal. There was no money for large-scale studies. We had small-scale case observations and studies, but they are of little scientific value. But SUPRATHEL® did not need that level of access. Our community of burns medicine surgeons is small in number and word gets around of what works and what doesn’t.

I have initiated and accompanied further studies and reviewed and evaluated others because I wanted to know whether our theories were right. For me, it wasn’t enough to see that SUPRATHEL® worked. I wanted to understand why it worked.

Twenty years is a long time for a medical product. Why is SUPRATHEL® still relevant today?

The SUPRATHEL® concept works to this day. The benefits continue to be relevant. Only a few other products can deliver them and only at a considerably higher cost. Prior to SUPRATHEL®, up to three changes of dressing per day was standard in some hospital departments. SUPRATHEL® made that obsolete and changes of dressing were reduced substantially in number, often to just one per cycle of treatment. That was a revolution for us physicians, for the nurses, and for the patients.

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Interview with Professor Lars Kamolz on 20 Years of SUPRATHEL®: “If a Product Is Still in Use After Two Decades, That Is the Greatest Accolade”

University Professor Lars-Peter Kamolz MSc of Graz University Hospital in Austria is the director of its clinical Department of Plastic, Esthetic, and Reconstructive Surgery. He has used SUPRATHEL® to treat burns for two decades and recalls the paradigm shift that the product ushered in. Besides, he underscores the fact that SUPRATHEL® has, to this day, held a firm place in the treatment concept at clinics in more than 30 countries. He sees this fact as the greatest proof of the product’s success.

How long have you worked in the area of medical treatment of burns?

I have worked in this area for 25 years, starting in Vienna and since 2012 in Graz.

You have been a SUPRATHEL® user from the very beginning. When and how did you first come into contact with SUPRATHEL® or today’s PolyMedics?

We heard about SUPRATHEL® at the conference of the German-Language Working Group for the Treatment of Burns (DAV), at which it was presented. Its presence at the congress increased from year to year as more and more experiences and observations were shared. The German company approached important centers in Austria. As we had already heard about the skin replacement product it was easy to get into it – in the early 2000s after SUPRATHEL® had secured approval.

It must at this point be admitted that there is a degree of competition between Germany, Austria, and Switzerland, none of which wants to lag behind the others in trialing a new innovation.

What was your initial reaction when you heard about the product?

Curiosity always surrounds a new material. You want to see what the new material can accomplish and how it can find its place—its value—in the treatment concept. That is the really important point because many products are presented, but only a few eventually make the running. Every hospital has within the scope of the general standard a practice of its own that it pursues.

An additional factor in SUPRATHEL®’s case was that it was an entirely new product class: an epidermal skin substitute material. That naturally triggered a twofold curiosity.

Were other products around that worked on the basis of a similar concept?

A predecessor product, Biobrane, was used to treat 2a- to 2b-degree burns. It was a kind of nylon mesh, a synthetic skin substitute material for indications similar to those for SUPRATHEL®. There were problems with it so we swiftly switched to SUPRATHEL®. We use it almost exclusively, by the way, for treating 2b-degree, i.e. mid- and deep-dermal burns or a little deeper than is usual at German centers. You always look for the place in the treatment concept where the product is most effective.

What made the penny drop for you where SUPRATHEL® was concerned? When did you realize that SUPRATHEL® had the potential to revolutionize the treatment of burns?

We soon realized that the product has significant advantages in the indications for which we use it. Over time we have extended its use to deeper wounds.

Prof. Dr. Heinrich Planck told me that the Marienhospital in Stuttgart aborted an approval study because it could no longer justify treating patients conventionally. Did you feel that way too?

Yes, we did. There were certain patients about whom we are sure that it wouldn’t have worked previously.

Above and beyond the first use, I find the view over a period of time impressive. If a product is still in use after 20 years that is the greatest accolade. New materials come onto the market, competitors sound the attack. If a product succeeds in staying in the market as a standard, it is simply good.

SUPRATHEL® is a product that came from Germany and found its way into hospitals all over the world. It has opened up new opportunities in the medical treatment of burns: a lower number of changes of dressing and fewer skin transplants for certain kinds of wound.

Was there a certain moment, a special occasion, when you were especially happy to have SUPRATHEL® at the ready?

We certainly have had cases in which we believe that thanks to SUPRATHEL® we achieved results that would not have been possible without it. But we are not considering individual cases; we are looking at many, many cases. SUPRATHEL® and treatment concepts including SUPRATHEL® were and are an important extension of the treatment range.

Twenty years is a long time for a medical product. Why is SUPRATHEL® still relevant today?

Because it is good. For its indications it works as well today as it did five or ten years ago. It is nonetheless important to create new mainstays and develop existing ones further in the way that PolyMedics Innovations does. Development does not stand still and at some time or other there will be a product that is better.

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Interview with Dr Matthias Rapp on SUPRATHEL’s 20th Anniversary: “SUPRATHEL® is the second revolution in burn medicine”

Dr Matthias Rapp is the Director of the Center for Severe Burn Injuries at the Marienhospital in Stuttgart and a specialist in orthopedics and trauma surgery. A key SUPRATHEL® pioneer and a convinced user of the product from the very beginning, he was in charge of the first trials of SUPRATHEL® in the late 1990s and of conducting the approval study, which was called to a premature halt due to the better results achieved by SUPRATHEL®.

How long have you been working in the field of burn medicine?

I began in 1993 as an intern in the Trauma Surgery Clinic at the Marienhospital in Stuttgart and have worked in burn care medicine ever since. I am a specialist in trauma surgery and orthopedic and have been a senior physician in charge of the Center for Severe Burn Injuries at the Marienhospital since 2009.

When and how did you first come into contact with SUPRATHEL® or today’s Polymedics?  

In the mid-1990s promotion of the biomaterials landscape in Germany by the Federal Ministry of Education and Research was very high on the political agenda. Four competence centers were established, one of which was the Biomaterial and Organ Replacement Center (BMOZ) in the Stuttgart-Tübingen region. BMOZ scientists contacted us because they were working on a synthetic skin replacement for burns.

A much more pressing problem for us was to find a solution for treating split skin removal points and superficial second-degree wounds and burns, which in those days was still very painful. What we wanted was a product that reduced the number of bandage changes, relieved the pain and accelerated wound healing. The material had to be transparent to make the wound bed visible. Our preference was clearly for a synthetic material.

You need to remember the approach to treating split skin removal points back then. A split skin removal point is like a superficial second-degree burn. In those days they were treated with fatty gauze onto which a solution containing mercury was brushed daily to dry it. A nurse blow-dried the removal point daily. Vaseline was applied in the evening of the ninth day in order to shower and remove the bandage the next day. At that stage the wound had as a rule not yet healed and was still weeping.

Dr Helmut Hierlemann, a chemist, was in charge of developing the material at the BMOZ. Product maturity was to be achieved within a period of five years.

Were there other materials that worked with similar concepts?

In those days there were many products consisting of different materials. We tried them out and documented our findings, but none of the alternative materials fulfilled our expectations convincingly.

When did you first use SUPRATHEL®?

After trials of several materials Heinrich Planck and Helmut Hierlemann presented us with a new material that we were to test in the fall of 1998. It did not fulfill our original transparency requirement because it was milky white in color. Despite our initial skepticism we decided to test it. To our surprise the material immediately became transparent at the split skin removal point and didn’t need to be fixed. Wound secretion did not accumulate beneath the material and was able, due to its membrane property, to flow into the bandage so that the material did not float away from the wound. That made changing bandages on the wound superfluous, which for the patient was a great improvement on an otherwise painful change of bandage.

What was then your reaction to SUPRATHEL®?

After positive initial experiences we used V16, as SUPRATHEL® was initially called, a further 150 times, each of which I documented. The results were for us so convincing that we and the Employer’s Liability Insurance Accident Clinic in Berlin carried out a joint approval study of the product.

For the approval study I first used SUPRATHEL® on a split skin removal point on October 26, 1999. It was first used on a superficial second-degree burn on January 25, 2000. The pain felt during bandage changes was compared as part of the study. Using SUPRATHEL® reduced pain so much more than other materials did that the study was aborted prematurely.

I presented our first findings at the Fifth Central European Burns Congress in Brno, Czechia, on September 30, 2000. Due to the very low case numbers and lack of other studies doubts were cast on our initial results and the reactions there and at further congresses were highly controversial to begin with. The first comprehensive work on SUPRATHEL® with the findings of the approval study was published in 2007.

We were so convinced of SUPRATHEL® that we trialed more and more uses. The greatest advance for us was that we could treat second-degree burns with SUPRATHEL® and achieve good functional and cosmetic results. That also applied to deep second-degree burns treated with transplants of the patient’s own split skin that are at times described to this day as the “gold standard.” This change of treatment regime changed burn medicine and is described by colleagues as “the second revolution in burn medicine.”

Was there a certain moment, a special occasion, when you were especially happy to have SUPRATHEL® at your disposal?

I well recall a number of cases in which the effect and result of using SUPRATHEL® impressed me. Shortly after its adoption we treated a patient with superficial second-degree burns on 33% of the surface of his body. We were able to mobilize the patient without pain after five days, which was not the rule prior to the introduction of SUPRATHEL®. A second case was that of a patient with second-degree burns on 95% of the surface of his body. There was not enough skin of his own to cover the burns, so we used SUPRATHEL® and at the same time ordered cultivated autologous skin. When that was finally available four weeks later the burn areas treated with SSUPRATHEL® had almost completely healed. In another case we treated with SUPRATHEL® a patient with toxic epidermal necrolysis, a rare blister-forming skin disease caused by medication, who had lost 100% of the surface of his skin. Thanks to SUPRATHEL® we were able to save the life of that patient and many others.

Our experience shows how SUPRATHEL® was able to improve many people’s quality of life and how grateful patients were for the treatment. SUPRATHEL® significantly reduced pain during treatment and achieved good functional and cosmetic results. Since consistently using SUPRATHEL® we have no longer had to use substitute materials of animal or human origin.

How has collaboration with PMI continued to develop?

I played an active part in the introduction of SUPRATHEL® in the United States and several European countries and accompanied its first use in Israel. I have been able to train many colleagues from around the world at the Marienhospital. I give lectures on SUPRATHEL® all over the world at international congresses and in hospitals and have supported PMI from the outset in the further development of new applications.

Twenty years is a long time for a medical product. Why is SUPRATHEL® still relevant today?

There are several reasons for the ongoing relevance of SUPRATHEL®. In my opinion it is still the best product für a large number of medical indications. It is easy to use and does not require multiple application. For the patient that means less pain, less need for painkillers and, as a consequence, less stress. In addition, its use leads to fewer infections, a hjgh-quality new formation of skin, and a faster mobilization of patients. Nursing care can be reduced by simpler and more pain-free changes of bandage.

We need significantly less autologous skin to cover burn wounds, which in turn reduces morbidity due to skin removal sites. By using SUPRATHEL® we have been able to reduce by about two thirds the number of operations for second-degree burns.

Suprathel thereby contributes toward a significant conservation of resources.

I continue to be convinced of the outstanding properties of SUPRATHEL® and use it consistently for all appropriate indications.