RU2312658C1 - Film-forming aerosol for wound protection in treatment and method for its using - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention describes a film-forming aerosol comprising the following components: (1) block-copolymer of polysiloxane-polycarbonate (PS-PC) in the ratio of blocks PS:PC = (35-55):(45-65) as a base for formation of film-cover, 3-10; (2) chloroform as a solvent of block-copolymer and anesthetic agent, 90-97; (3) antiseptic preparation in alcoholic solution, 0.1-0.2, and (4) halogenhydrocarbon or their mixture as a propellant, 100-120. Also, invention describes a method for using aerosol. Represented aerosol solves problems associated with the dense fixation of protective cover, it doesn't require any disinfection of spray-coated aerosol films, provides high rate and convenience in applying curative-protective polymeric layers.

EFFECT: improved and valuable properties of aerosol.

2 cl, 4 ex

Description

The present invention relates to medicine, namely to aerosol compositions for spraying on the wound surface of film-forming solutions of synthetic polymers in order to protect wounds of various etiologies from mechanical damage and microbial invasion during treatment. The invention can be used in combustiology, dermatology, surgery.

The most important way to successfully repair damaged skin is to use materials that meet the following requirements.

1. The ability to protect wounds from mechanical stress, contamination and penetration of pathogenic microorganisms.

2. The ability to collect exudate, toxins, microbial mass, etc.

3. Adhesion to wound tissues.

4. A certain permeability to water vapor, ensuring the exclusion of both the formation of water bubbles under the coating and the excessive evaporation of water from the surface of the body.

5. Sufficient gas permeability to ensure regenerative processes requiring the presence of oxygen.

6. The ability, depending on operating conditions, to easily remove from the surface of the wound when replacing or resorbing with new skin.

7. The presence of biologically active action (cleaning the wound of necrotic tissues and decay products, the ability to stop bleeding, antiseptic activity, stimulating the recovery process, etc.).

8. Ease of use for both medical staff and the patient, ease of application and painless removal if necessary [M.I. Shtilman, Prince. Polymers of medical and biological purposes, M., ICC "Academkniga", 2006, p.182].

These requirements, with the exception of paragraphs 2 and 7, relate to protective wound coverings.

S.G.Shapovalov in the journal Pharmidex-Practician, 2005, No. 8, p. 38-39 draws attention to additional, very significant properties that coatings should have, including protective ones:

1) transparency

2) compatibility with treatment layers,

3) anesthetic effect,

4) resistance to sterilizing agents,

5) simplicity of design and manufacturing technology.

A wide range of requirements for materials capable of functioning in difficult conditions of the wound healing process, depending on the etiology and stages of its development (burns, especially of a high degree and with a large lesion surface, injuries, chronic wounds, skin ulcers) make it almost impossible to create an ideal coating meeting all these requirements. Often the same material must perform different functions at different stages of wound healing [M.I. Shtilman, Prince. Polymers of biomedical use, M., ICC "Academkniga", 2006, p.183].

Practical medicine still uses traditional textile dressings for closure and treatment of wounds: gauze, bandages, wipes, soaked in medicinal products [Russian chemical. Journal, 2002, XLVI, p.133]. However, wet-drying dressings do not provide adequate protection for the forming epithelium from excessive moisture loss and mechanical damage, for example, when healing burn wounds. At the same time, drying dressings saturated with exudate become vapor-gas-tight. Their replacement is required, which injures the neo-epithelium, the periods of restoration of skin tissues are extended, as a rule, with the formation of scars.

Therefore, for half a century, specialists constantly faced the problem of finding and creating new materials that protect wounds and facilitate their treatment. Such a standard for physicians and materials scientists was the properties of living human skin.

As a result of studying extensive information sources, it was found that film coatings lead most closely to solving the problem of creating “artificial skin” [M.I. Shtilman, Prince. Polymers of medical and biological purposes, M., ICC "Academkniga", 2006, p.191]. They are obtained from natural and synthetic polymers. The latter are preferred when choosing protective film materials, since they have higher strength characteristics. Two types of film materials are known:

a) finished films applied to the wound surface;

b) films formed directly on the surface of the wound from aerosol solutions.

The first group includes many film materials made from synthetic polymers and copolymers (polyurethanes, polyacrylates, polysiloxanes, polyethylene, polytetrafluoroethylene, their copolymers and many other derivatives). They are used as the outer protective layers of a medical dressing, consisting of two or more layers, including therapeutic and sorbing. Wound treatment can be effective if protective films have such properties that, to one degree or another, are able to meet at least 5-6 requirements.

Despite the large number of finished film coatings for wounds, including those with protective layers made of synthetic polymers, universal remedies have not yet been created that satisfy all or most of the requirements for successful wound healing.

Common disadvantages for pre-made films - coatings are:

1) the need for disinfection and storage in a sterile condition;

2) poor adhesion to the skin or to the lower layers of the coating (an adhesive layer is required);

3) the complexity of the designs and manufacturing techniques of medical dressings.

The essence of the following brief descriptions of patents testifies to the complexity of manufacturing and other disadvantages of wound coverings (from films of the first group).

US patent No. 4373519, NPK 602/43, 604/367, in 1983 protected, in particular, the use of finished films of silicone, polyurethane and acrylate as the outer layer of the composite wound dressing. Its treatment and sorbing parts are a fibrous matrix of polytetrafluoroethylene with a layer of particles of hydrophilic natural polymers and copolymers distributed in it, the matrix is additionally saturated with medicinal substances. The vapor permeability of water vapor through a protective film regulate its thickness in the range from 2 to 200 microns. The films are hermetically attached with a polyacrylic adhesive in toluene and the matrix is pressed into a protective film. Along with the technological difficulties of coating production, it is noteworthy to use polyacrylate as a protective layer, which is unable to provide “breathing” for the growing new epithelium.

Over the past decade, a domestic invention has been proposed [US Pat. RF 2125859, 1999, IPC ⁷ A61F 13/15, A61L 15/26] on a three-layer wound dressing, the outer layer of which is made in the form of a diffusion membrane of polysiloxanes or its copolymers. According to the authors, the outer membrane protects the healing layers from microbial invasion and mechanical damage. It is indicated that the vapor permeability of the protective layer is higher (2.0-2.6 mg / cm ² hours) than for intact skin (1.5-2.0 mg / cm ² hours), which, in our opinion, can lead to drying out the bottom of the wound and disrupt the regenerative processes of its healing. In addition, polysiloxane films have poor adhesion to the treatment layers, which impairs their protective properties [M.I. Shtilman, Prince. Polymers of medical and biological purposes, M., IKC "Akademkniga", 2006, p.194].

Means are also known for the treatment and protection of surgical wounds, skin ulcers, pressure sores 1) dressings (woven and non-woven), which, along with medications, contain polystyrene, a polyethylene-polybutylene three-block copolymer with silicone plasticizer, in order to form an elastic and transparent coating [US Pat. RF 2093190, 1997, IPC ⁷ , A61L 15/22] and 2) dressings made of foam rubber impregnated with a 10% solution of xylidone and coated on top with a plastic film that serves as a protective coating. The use of a polymer film allowed 2 times to reduce the number of wound complications [US Pat. RF 2120306, 1998, IPC ⁷ , A61L 15/22].

Of the modern skin substitute treatments created over the past few years, the US has received FDA approval for use in the clinical setting: Dermagraft, Alloderm, Apligraf, and Integra. The latter two are recognized as the most effective for the treatment of wounds of various etiologies (see chart) [http://www.jnjgateway.com/home].

Apligraf is a biosynthetic product consisting of epidermal keratinocytes and fibroblasts arranged in two layers, similar to the structure of living skin. This tool is used to treat diabetic and venous ulcers. This “soft” two-layer construction needs reinforcement with a mechanically durable, gas-vapor-permeable coating.

Integra is a two-layer coating, the therapeutic inner layer of which is a porous matrix of collagen fiber impregnated with a drug. The outer protective layer consists of a polysiloxane film 0.23 mm thick with vapor permeability close to that of normal skin. After 3 weeks of forming a new dermis, the external silicone film is replaced with an ultrathin layer of the patient’s transplant. Integra is used to treat severe burn wounds in case of damage to up to 80-90% of the skin surface. Most of the reports using Integra are positive, however, the problem of life threatening patients due to submembrane infections exists and requires a solution [http://www.karger.com/gazette167//Sheridan/images/].

The second group of film materials includes polymer films formed by spraying aerosol solutions or suspensions on wound surfaces or healing layers. Most often, these so-called aerosol films (coatings) are single-layer.

Aerosol formulations in the form of liquids or suspensions, along with the polymer, may contain painkillers, antimicrobials, and other medicinal substances. The latter should be compatible not only with each other, but also with a polymer base, solvent and spray component. Aerosol formulations are sprayed from cylinders under the vapor pressure of volatile substances: hydrocarbons, their halogen derivatives, carbon dioxide, etc.

The first publication on the creation of aerosol formulations appeared in an article by Hungarian authors E. Novak et al. In the journal Orv. Hetil, 1964, v. 105, p. 1602. It was about the latest (for that period) achievements in treating wounds with the Plastubol aerosol preparation based on polyacrylate with medicinal components. The polymer sprayed onto the skin surface formed a dense, elastic, hermetically adjacent film to the wound surface.

Clinical data Research Institute of Emergency Care. N.V. Sklifosovsky also testified to the advantages of the Plastubol film in the treatment of burn wounds of III-IV degree in comparison with traditional dressings. Depending on the etiology and severity of the wounds, their healing nevertheless lasted 20-30 days [Surgery, 1975, No. 4, p.32]. Due to the low vapor-gas permeability of the polyacrylate and its copolymers under the film, the normal course of redox reactions was disturbed, abundant exudation, formation and rupture of the blisters was observed, and, as a result, infection of the wounds with a sharp slowdown in their epithelization process to 30 and even 40 days. Therefore, not only Plastubol, but also all subsequent aerosol formulations based on polyacrylate and its copolymers are not devoid of these drawbacks to one degree or another and are not widely used.

In the 70s, Lifuzol and Statizol aerosols were created, similar in composition to the treatment part, with the same polymer base as polybutyl methyl methacrylate (BMK-5) and containing acetone and chladones - 11 and / or -12. The applied aerosol films formed on the surface of the wounds, as protective against infection, drying, and in the case of "Lifusol" as stimulating tissue regeneration, in all phases of the wound process.

Based on copolymers of acrylic acids, a system was developed - “Acrylasept” with the antibacterial drug N- (n-hexyl) pyridinium chloride for the treatment of wounds of various etiologies. However, this aerosol due to insufficient vapor-gas permeability of the films did not receive permission from the USSR Ministry of Health for use [Military-medical. Journal, 1985, No. 1, p. 60].

In the future, as follows from the publication of B. M. Paramonov [Terra Medica nova, 2004, No. 1, pp. 2-6, table.], The most widely used for the treatment of superficial wounds and burns were film-forming aerosol preparations “Naxol” (Hungary) as well as Olazol and Hypozol. "Naxol" is an alcoholic solution of medicinal plant extracts, trace elements, essential oils, enzymes, inorganic salts, hormones, wax, tannins, carbohydrates in a certain ratio. “Olazol” and “Hypozol” are water emulsion aerosols containing alcohols, acids, acid esters, anesthetics and medicines, sea buckthorn oil and propellant freon-12. According to B.M.Paramonov, these aerosol compositions have a complex effect in the I and II phases of the wound healing process. The remaining 12 aerosols were not considered effective enough for clinical use. It should be noted, however, that aerosol films from the compositions of these grades are referred to as “soft” coatings. Therefore, there is always a risk of mechanical damage to the film, violation of the continuity of the coating and injury to the wound.

From foreign film-forming compositions, the Opsite Spray of Smith and Nephew Ltd. is known, which when sprayed onto injured skin (cuts, scratches, abrasions) forms a transparent and drying film within 30-40 seconds [Smith and Nephew Medical-Catalog]. The composition contains an acrylic copolymer - 3.6%, a solvent - acetone / ethyl acetate - 40.4%, propylene - 56%, is only protective and is valid for 12 hours. In surgery, it is used to treat wounds after removing stitches, removing needles, places for administering vaccines and dry sutured wounds. To achieve the best result, it is recommended to perform several applications. Remove the film after complete drying and the beginning of peeling of the skin [http://www.polyuspharm.com/].

This year from the INIBSA S.A. Laboratory (Spain) received information on the release of a composition based on polymethacrylate with various medications in aerosol packaging called "Nobecutan". Aerosol is used to treat traumatic wounds, burns of a low degree, resorption of sutures and scars. In some cases, solvents are additionally used to remove the film after treatment: acetone or ethyl acetate [http://www.gneaupp.org/catalogo/alters /nobecutan.htm].

In the early 2000s (Copyright 2004), the new BENEV-Silicone-Spray catalog [http: //www.skinstore. world-stores.net/products/BENEV-Silicone-Spray.htm], which briefly describes silicone aerosol-gel as an effective tool for accelerating the treatment of wounds and resorption of hypertrophic scars. As noted, the composition of the aerosol includes "self-linking" silicones purified for medical use and distilled water without specifying a spray component and any medicinal additives. The gel-like composition is applied to the wound surface using an aerosol method with the formation of a monomolecular polymer layer on the surface as a protective layer against the penetration of bacteria and fungal infections. Polymer silicone film provides simultaneous access to the oxygen wound and maintains the necessary moisture. Aerosol is sprayed onto the wound many times in thin layers until the desired treatment result is obtained.

The following features of the application of the BENEV-Silicone-Spray aerosol composition are noteworthy:

1) during spraying, a monomolecular ultrathin layer of silicone is formed, which therefore cannot protect the wound for a long time;

2) it is recommended to repeatedly spray (day and night) an aerosol with layering of the thinnest films, which suggests the possibility of breaking the continuity of an ultrathin polymer coating on the skin;

3) certain inconveniences are created for medical personnel if multiple wounds are to be treated.

The listed features of the use of this aerosol cannot be attributed to its positive characteristics.

According to the main purpose and composition of the aerosol (contains silicone polymer), it seems possible to choose BENEV-Silicone-Spray for the prototype of our invention with the elimination of the noted disadvantages.

The use of film-forming aerosols for spraying polymer compositions onto wound surfaces compared with the use of ready-made films for covering wounds during their treatment has a number of common undeniable advantages:

1. The problem of tight fixation of the protective coating is solved especially on wounds of complex shape without applying adhesive layers or an adhesive substrate under the film.

2. No disinfection of sprayed aerosol films is required, unlike finished film materials.

3. There is no need to store the films under sterile conditions.

4. Achieved high speed and ease of application of protective medical polymer layers formed on the wound surface from aerosol solutions, including colloidal. (A high rate of wound closure is extremely important when injuring a large surface of the body)

Along with the general advantages in the application and properties of aerosol films (compared to finished films) there is an objective difficulty in developing their compositions. As noted earlier, all components of the aerosol must be physico-chemically compatible with each other, without causing destructive processes within the composition and the occurrence of toxic products.

Therefore, the authors faced the task of developing a polymer-based aerosol composition for reliable closure of surface wounds of various etiologies (especially large-area burns) with a film that satisfies the greatest number of requirements for protective and therapeutic coatings.

As a result of scientific research, research and successful clinical trials, an aerosol of the following qualitative and quantitative composition was developed, wt.h .:

1. Polysiloxane-polycarbonate block copolymer (PS-PC) with the ratio of PS: PC blocks in the range (35-55) :( 65-45), forming a film 3-10 2. Chloroform as a solvent and anesthetic substance 97-90 3. A mixture of halocarbons (freons grades 21, 22 and 142B) as propellant 100-120 4. Antiseptic drug 0.1-0.2

The aerosol preparation method consists of two operations:

1. Dissolution of the polysiloxane-polycarbonate copolymer in chloroform, followed by the addition of an antiseptic drug to the solution.

2. Loading the resulting PS-PC solution into a cylinder and chladones under pressure.

A method for using an aerosol is also proposed, which consists in spraying it on a wound surface from a distance of 10-30 cm with pulses for 2-3 seconds, forming a polymer film 5-20 microns thick and adjusting its gas permeability depending on the thickness and composition, in Phase I of the wound process as a temporary medical dressing; in Phase III - as a protective coating of the treatment layer with the resulting neoepithelium and, finally, on the injured areas of the donor skin after removal of autodermaloscopes, ensuring the growth of the missing epithelium ial layers of the skin.

The aerosol film (coating) formed from PS-PC of the block copolymer formed on the wound surface complies with 11 requirements for protective materials for the restoration of damaged skin.

The ratio of PS-PC blocks we determined in the block copolymer and its found concentration in a solution of chloroform mixed with halide hydrocarbons (freons of grades 21, 22 and 142B) in the required proportion in the aerosol composition, when spraying the block copolymer on the wound surface, forms a uniform film - coating for 10-15 seconds. The coating provides a water vapor permeability of 300-400 g / m ^{2 for} 24 hours at 37 ° C, which is close to its values during metabolic processes of living skin.

The film adheres tightly to the wound or healing layer, including to the surface of complex shape (relief), creating a barrier against the penetration of microbes from the outside and mechanical damage. At the same time, it is strong, thin and elastic; it does not limit the movements of any parts of the body.

Used in the first phase of the wound healing process as a temporary medical dressing, in addition to the protective functions mentioned above, the film disinfects the wound surface due to the antiseptic additives in the alcohol solution in the aerosol. These include: brilliant green, blue, iodopyron and some other iodine-containing compounds.

In addition, which is very important with a wide area of damage, the aerosol has an analgesic effect on wounds. This is due to the anesthetic properties of chloroform, which blocks the generation of impulses at the ends of the sensory nerves and their conduction along nerve fibers during gradual evaporation. Before applying the treatment layer (biological dressing) during the wound toilet, the film is easily removed along with dead tissue.

In the III phase - an aerosol film is sprayed onto the treatment layer with the resulting neoepithelium to protect it and form the upper layers of the epithelium with the provision of "respiration" and the required moisture content of the wound. In this case, as shown by clinical trials, the biochemical characteristics of the PS-PC copolymer helps to build up the missing skin epithelial layers.

The same thing happens when the film closes the injured areas of the donor skin - the places where the autodermaloscoats are taken (for the treatment of deep burns), where the aerosol coating performs to some extent the function of a medical-protective layer.

The transparency of the coating allows you to observe the healing process of wounds.

Restoration of the skin is completed after 7-8 days, after which the polymer film peels off independently and painlessly from the wound surface.

According to the positive results of toxicological and sanitary-chemical studies conducted in 2006, the composition of the aerosol and polysiloxane-polycarbonate block copolymer exhibit bioinertness both to living wound tissues, and to sorbent and therapeutic dressings, including cultured allogeneic fibroblasts and other drugs from donor skin of animals and humans, as well as biodegradable substrates (collagen, gelatin, chitosan), gel and hydrogel layers.

Thus, a number of “soft” coatings can be reliably protected by our PS-PC aerosol film.

The successful use of the proposed aerosol composition with spraying of a PS-PC copolymer film for wound protection during treatment in phases I and III of the wound healing process can be illustrated by examples of effective healing of burns of the II and III degrees in clinical conditions.

Example 1

Patient K., 63 years old. Diagnosis: III degree burn with _a flame of 8% bp Delivered to the hospital 4 hours after the injury. Upon receipt, the surface of the wounds was treated for 8-10 with pulses of an PS-PK block copolymer of a 3% concentration in chloroform mixed with freons - 21 and - 22 in equal proportions. (The ratio of blocks in the copolymer PS: PC = 35: 65, the content of the antiseptic is 0.16 parts by weight in 100 parts by weight of solution).

The next day, the toilet was made wounds with the removal of the polymer film with gauze swabs. Then, wound surfaces with an area of 1500 cm ² were covered with a biological dressing based on cultured live allogeneic fibroblasts. On the third day, a monolayer of neoepithelium was observed over the entire area of the wounds, which was then covered with an aerosol film to protect it from drying out, mechanical damage and stimulate the growth of epithelial layers (PS: PC ratio = 40: 60). On the 7th day, a full-fledged multilayer epithelium was formed on the wounds, the protective film peeling off independently and painlessly from its surface.

Example 2

Patient, 71 years old, diagnosis: III degree burn with a flame of 26% bp, of which 15% - III _b degree. Upon admission to the hospital 2 hours after the injury in a state of burn shock, all the patient's wounds for disinfection, anesthesia and protection were treated for 15-17 with short pulses with a PS-PC aerosol solution in chloroform with a block ratio of 50:50. (The content of the block copolymer is 5 parts by weight per 95 parts by weight of chloroform mixed with freons 21 and 142B in a ratio of 1: 1.1; the amount of antiseptic is 0.2 parts by weight per 100 parts by weight. solution). On day 3, a biological dressing was applied to wounds III _and burns with an area of 1980 cm ² after their toilet, after which a monolayer neo-epithelium was formed after 3 days, to protect which a PS-PC film 10-15 μm thick was sprayed onto the surface of the wounds. The composition of the aerosol is the same as when treating the patient upon admission with the application of a temporary dressing in the form of an aerosol film (see above), with the exception of an antiseptic, the content of which is 0.1 m.h. per 100 m.h. solution. After 8 days of applying the protective film, layers of a multicellular scarless epithelium formed on the surface of the wounds. The protective film on its own moved away from the healed wound.

Deep burns III _b degree, after removal of the temporary medical dressings from PS-PC were closed autodermoplasticheskimi flaps.

To heal donor sites, they were treated with an aerosol - solution with a concentration of block copolymer of 7 m.h. 93 mph chloroform (with the ratio of PS: PC blocks = 45: 55) with the formation of a copolymer film with a thickness of 10-15 microns. The content of the antiseptic drug is 0.2 m.h. in solution per 100 m.h. chloroform. There was an accumulation of blood under the film, upon drying of which a brown scab was visible. The stratified epithelium on the donor site formed on the 7th day 2-3 days earlier than with the traditional treatment of patients.

Example 3

Patient V., 49 years old, diagnosed with boiling water burns II and III _a degree 18% dc He entered the hospital 2.5 hours after the injury. The wounds were treated for several seconds with a film-forming aerosol-PS-PC solution with a concentration of a block copolymer of 10 m.h. 90 mph solvent, which is mixed in a ratio of 1.0: 1.2 with freon - 142V. (The ratio of PS: PC = 40: 60, the content of the antiseptic is 0.14 m.h. in 100 m.h. solution). A protective film with a thickness of 15-20 μm served as a temporary medical dressing, which was easily removed on the second day along with non-viable tissues during the toilet wounds. To form neoepithelium, the wounds were closed with a biological dressing, on the surface of which, after 3 days, a monolayer of the epithelium appeared. To protect it and to build up the upper epithelial layers, a film of 5-10 microns thick was sprayed onto the wound surface from a similar aerosol composition, under which on the seventh day a complete scarless epithelization of wounds occurred. The polymer film exfoliated independently from the epithelium.

Example 4

Patient A., 18 years old, diagnosis: burn II and III _and degree of 45% PT Delivered to the hospital 5 hours after the injury.

Most of the wound surface was covered with a non-removable scab. On the entire burnt surface, as a temporary medical dressing, a PS-PC protective film was applied with a thickness of 10-15 μm from an aerosol consisting of 6 m.h. copolymer 94 mph chloroform mixed with freon - 22 and - 142B in a ratio of 1: 1 and containing an antiseptic in an amount of 0.18 m.h. per 100 m.h. solvent. (The ratio of the blocks PS: PC = 55: 45). On the second day after the toilet of burn wounds and removal of the film with dead tissue, a biological dressing was applied to the wound surface without a scab with an area of 2100 cm ² . Three days later, under the dressing, the formation of neoepithelium was observed. A composition similar to the above, which formed a protective film with a thickness of 15-20 μm for the growth of epithelial layers, was applied to the neoepithelium by the aerosol method. On day 7, a multilayer smooth epithelium with no signs of scarring formed under the film. PS-PC film peeled off easily and painlessly from the skin.

After removing the temporary dressing, wounds with a scab were covered with dressings with Levomikol ointment. Healing after scab removal during ligation occurred 24 days after injury with the formation of hypertrophic scars.

The use of the proposed aerosol composition for closing wounds in the treatment of 14 patients with extensive burns under clinical conditions led to a complete restoration of the structure of the epithelium on all wound surfaces, the formation of neo-epithelium under the influence of a medical dressing, and the epithelial layers under the PS-PC film were averaged 7 days at III _a degree burns, i.e. 2 times faster than when using polyacrylate films.

The aerosol coating (dressing) from PS-PK has proven itself in the treatment of venous trophic ulcers in the II-III stages of the wound healing process with microbial contamination of wounds not exceeding 10 ⁴ microbial bodies / cm ² . Coating contributed to the maturation of granulation tissue and marginal epithelization. Convenience and painlessness of the change of coating was noted. Side effects were not observed in any case. The aerosol film did not interfere with the application of a compression band formed by elastic bandages.

Application of allogeneic fibroblasts with subsequent protection of the epithelium with an aerosol dressing PS-PK was used to treat pressure sores. Treatment with a film-forming aerosol solution of the affected tissues led to a decrease in the level of pain due to the anesthetic properties of the proposed composition and reliably protected the injured surface from mechanical stress.

The PS-PK aerosol protects abrasions, namins, wet corns, and rubbing well with a spray coating thickness of 20–25 μm and can be used to restore skin tissue in dermatology. The tests performed in outpatient practice confirm such recommendations.

Thus, the essence of the invention meets most modern requirements for the properties of coatings and their use for the successful treatment of wounds of various etiologies, such as: 1) protection of the wound from mechanical damage, contamination and microbial invasion; 2) reliable fixation on skin tissues and healing layers; 3) biocompatibility and inertness to living tissues and therapeutic drugs; 4) vapor permeability, excluding both the accumulation of exudate under the film and excessive evaporation of moisture from the surface of the wounds; 5) gas permeability necessary for regenerative processes on the wound surface; 6) the anesthetic and disinfecting effect of the coating; 7) transparency of the protective layer; 8) the simplicity of the design of the aerosol container and the preparation technology of the composition; 9) for medical staff: ease of use and ease of aerosol spraying using 97% of the net mass from a closed container; 10) painless film removal and self-peeling it after restoration of the skin; 11) the lack of a stage of disinfection of films and their storage under sterile conditions.

Claims (2)

1. Film-forming aerosol for protecting wounds in the treatment based on a synthetic polymer, characterized in that it consists, wt.h .: 1) polysiloxane-polycarbonate block copolymer (PS-PC) with the ratio of PS: PC blocks = (35-55) :( 65-45), as the basis for the formation of a coating film 3-10; 2) chloroform - a solvent of a block copolymer and as an anesthetic substance 97-90; 3) an antiseptic drug in an alcohol solution - 0.1-0.2; 4) halocarbon or mixtures thereof as a propellant 100-120. 2. The method of applying the aerosol composition according to claim 1 by spraying it onto a wound surface from a balloon under pressure, characterized in that the spraying is performed at a distance of 10-30 cm from the surface with several pulses of 2-4 s, adjusting the vapor and gas permeability of the formed polymer films - coatings with its thickness and the ratio of PS and PC blocks in the block copolymer, depending on the required properties in different phases of the wound process.