Bio-skin or too expensive bandage?
The fate of inventions. Why the Russian "bio-skin" does not enter hospitals
This drug has not yet been put into service by Russian doctors. АиФ.ги I understood the reasons.
More than 500 thousand people are burned every year in Russia, a third of them are hospitalized. Healing takes a hard and long time, dozens of scientific institutes around the world are working to solve the problem. A few years ago, Russia announced that a panacea for skin ailments had been found. It was invented by Orenburg scientists. The so-called "bio-skin", as conceived by the creators, should fulfill the purpose of an innovative patch that forms a film over the damaged area of the skin, under which the healing process takes place.
However, today not all clinics in the country use artificial "bio-leather", and doctors' opinions about the invention are often completely opposite.
Kitchen of InnovationThe research and production laboratory of cellular technologies is located in several rooms in the building of the student polyclinic at Orenburg State University.
It can only be identified by a sign: no metal doors with endless codes, as in American films. Inside, it is also quite prosaic: stands with countless diplomas, photographs of top officials of the state, a stack of disposable clothes for guests. After going through several rooms with isolated air space (precautions against infections and viruses), I find myself in the laboratory itself.
"Don't pay attention, we have a lot of laboratory utensils here, any hostess will envy," Ramil Rakhmatullin, candidate of medical Sciences, inventor of the Russian "bio–skin", greets me. "Everything looks simple enough, but we managed to set up a dust–free supply and exchange ventilation system in a conventional laboratory and delimit the territories for their intended purpose."
A young scientist opens an ordinary refrigerator and takes out a container filled with opaque liquid and foam. "There are impurities at the bottom, but this white foam is hyaluronic acid," the scientist comments.
In modern bioengineering, "hyaluronic acid" (as experts sometimes call it) is the gold standard, the basis for breakthrough technologies. A group of Orenburg innovators receives it from the Institute of Micro- and Nanotechnology of the State University, where the molecules of matter are structured. Hyaluronic acid itself is isolated from the crests of roosters of a special breed brought from Bashkiria. The air phase of this "hyaluronic acid" is driven through an apparatus very similar to a kitchen mixer. The well-mixed gel is poured onto trays and sent "for baking". In "cabinets" with ultraviolet light and laser treatment invisible to the eye, hyaluronic acid is stored for 4 to 6 hours, after which the resulting thin plates are cut on a special device – in the shape of a face with slits for eyes, as well as into curved strips similar to a boomerang – for trophic ulcers.
The packaging of the product goes here: a young girl manually packs the cut plates into polyethylene. I ask if the parts are broken? She replies that she has already adjusted, and the "skin", fragile as parchment, almost does not suffer. The entire production process takes a working shift. The mandatory stage is gamma irradiation, that is, sterilization of products obtained in Moscow.
Bioplastic fire resultsRamil has been working on obtaining a "bio-skin" since 1999.
Then he had to bring out prototypes for the replacement of the eardrum as part of his PhD thesis. After the defense, Rakhmatullin changed the research base: he moved from the medical academy to Orenburg State University.
There, in a specially created laboratory of cellular technologies, Ramil began to look for how to make a bioplastic material from hyaluronic acid in a different way from foreign colleagues. Analogues of the product abroad already existed, but they were and remain very expensive.
For several years in the early 2000s, scientists worked almost to no avail. Having tried all types of radiation on Soviet equipment – a photochemical box – we settled on one range in the field of ultraviolet radiation, which few people use in science. It is not known how long the experiments of a group of scientists from three people would have lasted, but chance helped them.
"One day after an unsuccessful experience, I went home for the weekend and forgot to turn off the device. There was a rise in temperature, pressure, a mini-fire. The guards called me in the middle of the night, I was already preparing for dismissal, as in this box we found a terrible, burnt piece of plate, this was the first prototype of our bio–skin," Ramil Rafailevich recalls that day.
Having brought to mind the bioplastic results of the fire, the Orenburg residents called their creation "Giamatrix". It was the first such Russian development, which soon thundered throughout the Orenburg region and even the country as a long-awaited remedy for painless healing of burn wounds.
Bandages-competitorsRamil's first patient was his mother: scalded with boiling water, she could not heal the burn for a long time – nothing helped, and her hand hurt unbearably.
Ramil spent the whole summer working as a doctor in a surgical office, testing his invention.
The media quickly found out about the scientists' invention, and calls poured in from all over Russia. Then there are exhibitions, meetings with top officials of the state, participation in foreign competitions.
However, problems actually arise with the mass use of "bio-skin": even in their native land, only three hospitals have well accepted the local innovation.
"Our opponents usually have one argument: you are not in the federal standard of treatment. The method is traditional, it is not psychic, not hypnosis, it fits into the canons of treatment, but requires changing stereotypes. Doctors, apparently, can't stop bandaging wounds. It's like with smartphones: if there are no buttons, then it's not a phone? Just another technology!", Ramil is perplexed.
Moreover, the scientist himself does not deny that this is a bioplastic material intended for the treatment of burns and trophic ulcers, and is most often used as a wound dressing, and it does not need to be changed, it resolves itself.
Ramil Rafailevich says that they achieve at least 50% efficiency in a group of patients who are not helped by anything. The scientist also assures that Giamatrix has received official permission for use in medicine from Roszdravnadzor.
Then the question is: why is "bio-leather" not used everywhere and massively?
Some Orenburg scientists and doctors believe that the Orenburg "bio–skin" does not have a healing and wound-healing effect, and its destiny is cosmetology. By the way, Rakhmatullin has released a whole line of creams based on hyaluronic acid.
Expert opinionWe asked for comments from professional practitioners-combustiologists, specialists of burn and surgical profiles of Orenburg and Russia with the question whether they use Ramil Rakhmatullin's bioplastic material in their work.
Head of the burn department of the City Clinical Hospital No. 4 Orenburg Alexander Chekanin is very skeptical about the invention: "What is presented to us as a bio-skin, in fact, has nothing to do with it, it's not even a bioplastic material! This is an ordinary wound coating based on hyaluronic acid, far from the best. Yes, it was promoted, the name is very well-known, but we do not use this material in our practice. We work with proven, more effective, but less expensive wound coatings on many patients. Last year, our regional Ministry of Health assembled a commission to consider this issue, they explained that you need to call a spade a spade, the invention of Rakhmatullin is another type of wound coating, nothing more."
Another doctor, Olga Frolova, head of polyclinic No. 3 of the City Clinical Hospital No. 3. Orenburg, uses the innovative invention of Ramil Rafailevich and gives him a good assessment: "Our main job is to provide outpatient care to the population, but there are qualified specialists who are interested in experimenting with new products. For more than a year we have been using "bio-leather", for people it is a paid service, but relatively inexpensive, provided almost at a purchase price. The results are not bad, the healing process of burns and various injuries resulting from blood supply disorders is accelerated. We use the material together with regenerating creams."
Andrey Alekseev, Professor, Doctor of Medical Sciences, head of the burn center of the Vishnevsky Institute of Surgery, told his opinion on the Orenburg innovation by phone: "It's wrong to call it bio-skin, it's the most ordinary wound dressing. You can also call it a temporary skin substitute, I repeat again – temporary. This bandage can only be used for superficial skin injuries, for shallow burns, trophic ulcers. Maybe, thanks to hyaluronic acid, it can be used in other areas of medicine, I can only speak with confidence about my profile. "Giamatrix" is effective, but only in combination with other means, and there are dozens of them in our arsenal! The wound dressing, which was invented in Orenburg, we do not use often, 1 cm costs about 10 rubles, it is expensive for the CHI system."
Evgeny Zinoviev, Professor of the Department of Hospital Surgery of the Ministry of Health of the Russian Federation, surgeon of the burn department of the Leningrad Regional Clinical Hospital, has used "bio-leather" several times in his work: "Giamatrix" is a bioplastic material, the uniqueness of which is in the method of processing hyaluronic acid. In our work, we use it to heal borderline, superficial dermal burns, deep burns after removal of dead tissues at the stage of preparation for skin grafting, treatment of donor wounds. We will try a new generation of the material, which is still undergoing clinical trials, for the treatment of trophic ulcers, complications of varicose veins, diabetic foot syndrome. We do not always prescribe it, but according to indications, but it is definitely better to use it than some antibacterial ointments and wound coatings. We received this material as a gift from the manufacturer several times during the summer and autumn."
The opinions of experts once again confirm the complexity of the introduction of technologies, especially in medicine – one of the fastest growing areas, but at the same time one of the most conservative. Every year there are a lot of new medicines, new technologies, some of them based on those already tested more than once, others represent a real breakthrough in medicine. In addition, the process of introducing new things in medicine goes through a rather long process of clinical trials, examinations and approvals, which can stretch even for decades.
Was the myth created by journalists?In Soviet times, there was a common phrase: "Science is the satisfaction of one's own interest at the state expense."
Now with the state financing of scientific inventions, everything is not so simple, scientists say, sometimes you have to look for funds for research yourself, which can last for years and decades.
Six years have passed since the first information about the Orenburg "bio-leather" appeared.
The name of Ramil Rakhmatullin, now the head of the research and Production laboratory of Cellular Technologies at Orenburg State University, has been constantly flashing in the press since then - he flies to conferences, forums, exhibitions, gives master classes, receives all kinds of awards for innovative developments.
But here is the question – why since then there has been no mass use of this bioplastic material in Russian, and, above all, in Orenburg clinics?
"Maybe the Orenburg residents, having heard 6 years ago about the all-healing bio-skin, put too much hope on it? Maybe the product is really incomplete and requires time to improve it?", – practitioners ask questions. Many doctors say that this is not a wound-healing bioplastic material, as previously positioned, but a wound dressing. Moreover, it suits some as one of the components of complex treatment, and for others it is unacceptable because of the high cost.
The cost of packaging the material, according to the developers, is less than $ 100, and when contacting the help desk of one of the Orenburg pharmacy chains, we learned that we could order Giamatrix, four plates of which measuring 10 by 15 centimeters will cost 22 thousand rubles. The waiting period for the material is 70 days.
Ramil Rakhmatullin officially stated that Giamatrix has not been produced since November 2012 due to preparations for the release of second-generation bio-leather.
Rakhmatullin says that the Orenburg "nanopautinka" (as local journalists called it) is experiencing a rebirth: many properties of the former matrix have been improved. In addition to its use in the healing of burn wounds, it is stated that the new brand of bio-skin "G-Derm" can be used in surgery as an alternative to surgery for stomach ulcers, in dermatology, otosurgery and other fields of medicine. The same key parameters were stated earlier, in the first generation of Giamatrix bio-leather, which managed to become a prize-winner of innovative forums.
Largely thanks to the publication about the presentation of "bio–leather" in Israel in the federal issue of the weekly "AIF" No. 30 (1707) on July 24-30, 2013, according to Ramil Rakhmatullin, he received an offer to support the serial production of "bio-leather" of the second generation. In the near future, a plant will appear in Orenburg that will produce the drug for 5 thousand packages per month.
This volume should be enough to bring the product to the Russian market. The only question is, will doctors and patients take advantage of this? Will there be a therapeutic effect expected from the use of this bioplastic material? Or will "G-DERM", like its predecessor, turn out to be a wound dressing, and not a wound-healing material?
Only time and clinical trials will help answer these questions.
Portal "Eternal youth" http://vechnayamolodost.ru29.11.2013