Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
  • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
  • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
  • A61L15/42—Use of materials characterised by their function or physical properties
  • A61L15/60—Liquid-swellable gel-forming materials, e.g. super-absorbents
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
  • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
  • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
  • A61L15/22—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
  • A61L15/28—Polysaccharides or their derivatives
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
  • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
  • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
  • A61L15/42—Use of materials characterised by their function or physical properties
  • A61L15/62—Compostable, hydrosoluble or hydrodegradable materials

Definitions

• the subject of the present invention is a wound dressing material, a wound dressing, an application of dibutyrylchitin and chitin reconstituted from dibutyrylchitin 20 in the production of a wound dressing, and a method of producing a wound dressing material and a wound dressing.
• the subjects of the present invention serve to produce a wound dressing material of arbitrary size and shape.
• Chitin is a natural polymer, whose biological properties have been established in 25 the course of scientific research.
• Chitin and its derivatives can occur independently or in a mixture with other pharmacologically admissible additives, as well as with compounds with documented therapeutic activity.
• the polymer chain must be modified.
• One 30 of the modifications is to produce an esterified derivative of chitin, dibutyrylchitin.
• Dibutyrylchitin is obtained by way of the estrification of chitin, mostly of animal origin, with butyryl anhydrate.
• the dibutyrylchitin obtained is soluble in organic solvents, such as acetone, ethanol, methyl chloride, dimethulsulphoxide, N-methylpyrolidone or dimethylformamide.
• organic solvents such as acetone, ethanol, methyl chloride, dimethulsulphoxide, N-methylpyrolidone or dimethylformamide.
• the significant property is the ability of dibutyrylchitin to revert 35 into the form of reconstituted chitin.
• Reconstituted chitin is obtained through the alkaline hydrolysis of dibutyrylchitin.
• Dibutyrylchitin fibres are highly biocompatible with a living organism, just like chitin, they biodegrade and accelerate wound healing. These properties have been confirmed with both in vitro and in vivo studies.
• Chitopack C encompasses chitozan fibres, termed cotton-like, 2 - 20 mm long and 20-50 ⁇ m along the cross-section and 3-15 ⁇ m across the cross-section, which are used to make fibrous wound dressings.
• a dressing under the name of Besc tin from U ITIKA Co. is produced in the form of a fibre mat from crab chitin.
• Another type of fibrous material are Chitopoly fibres produced by Fuji Spinning Co. Ltd.
• Polinosic-type fibres with a surface layer of chitozan are Polinosic-type fibres with a surface layer of chitozan.
• All of the above mentioned dressings in the form of fibrous mats are produced from cut fibres using a method of fleece formation similar to that of papermaking.
• ENSAI Co. Ltd. has marketed two wound dressings called Chitipack S and Chitipack P.
• Chitipack S contains marine-derived chitin in the form of foam, whereas in Chitipack P chitin it is formed into bundles.
• the hydrocolloid dressing, Tegasorb, from 3M is composed of a dispersion of polyisobutayrylene and chitozan particles.
• Patent description KR9504916 presents a method of producing membranes from chitin and its derivatives.
• the homogenous surface of the membrane and its many beneficial physical properties were obtained through the exchange of components of the coagulation bath, used in the coagulation of chitin and its derivatives.
• the coagulation fluid was composed of water, ethyl ether, and metal salts with a mass ratio of 9 : 1 : 0.05-0.3.
• the metal salts were calcium carbonate or lithium carbonate.
• the chitin derivatives were chitozan, ethylchitin, acetylchitin, butyrylchitin and propionylochitin.
• Patent description JP5345834 presents an antibacterial and antifungal porous polyurethane material.
• the material was obtained through the incorporation of polyurethane resin with 0.5-5% by mass of purified, reconstituted granular, porous chitozan, such that the porous structure was preserved.
• the chitozan is obtained through the addition of an acidic aqueous solution of chitozan to the base solution through dripping, so as to form reconstituted chitozan spheres, such that they are then washed with water and sprayed.
• Patent description JP2002363083 (published 2002.12.18) presents an aerosol for spraying onto wounds.
• This preparation is obtained through the filling of a tank with particles of highly particulated matter in solid state, with a low molecular mass, and reconstituted chitozan with an average molecular mass of 10,000-200,000, with a particle diameter of 1.0-11.0 ⁇ m in solid form, with a particle diameter variance coefficient of 0.50-1.35.
• Patent description CA2050873 (published 1998.06.30) describes a method of producing chitozan sulphonate, in which the hydroxyl groups at positions C3/C6 are selectively sulphonated with inexpensive sulphonating agents, containing dissolved or saturating chitozan in acetic acid and water. Chitozan is regenerated with an alkaline aqueous solution, washed with water and then alcohol.
• Patent description JP6211903 (published 1994.08.02) describes the production of chitozan sulphate of high purity and high viscosity, as well as of a sulphonating agent for chitozan.
• Patent description JP63210101 (published 1988.08.31) described a method of producing ultra pure, porous chitozan and chitin molecules.
• Patent description PL 169077 (published 1994.01.24) describes a method of producing dibutyrylchitin.
• Dibutyrylchitin is obtained by way of the estrification of chitin, usually from krill, with butytyl anhydrate.
• the technique of producing fibres using a traditional wet weaving approach is the subject of patent PL187224 (published 1998.12.21), which describes a method of producing dibutyrylchitin fibres from weaving solutions into aqueous coagulation baths.
• the weaving solution also contains a plasticizing agent, in addition to the polymer and solvent.
• the solvent is usually one of the classic organic solvents: acetone, methanol, ethanol, dimethylformamide, dimethylacetamide or dimethylsulphoxide.
• the plasticizing agent used was glycerol or ethylene polyglycol.
• the dibutyrylchitin concentration in the solution was 5-30 parts by mass, and 1-10 parts by mass of plasticizer.
• Such a solution is pumped through into the coagulation bath, containing water or an aqueous solution of solvent.
• the solidified fibre is sfretched in a water bath at a temperature of 80°C to a length of 50-500% .
• Patent description US 4651725 (published 1987.03.24) describes a wound dressing material composed of chitin derivative fibres, and a minimal tensile strength of 2 g/d.
• the chitin fibres are mixed with binding fibres, where the latter are highly biocompatible.
• this solution describes the following polymers: vinyl polyalcohol, carboxymethylcellulose, acryl acid esters, vinyl acetate, vinyl acetate copolymers, vinyl chloride, natural or synthetic rubber, as well as gelatine and starch.
• the by mass fraction of chitin fibres in relation to linking fibres is from 80:20 to 95:5.
• the wound dressing uses a polymer obtained from the armour of crustaceans or insects. It is prepared in hydrochloric acid and caustic soda in order to remove calcium and proteins. As a result of subsequent chemical modifications the following chitin derivatives are obtained: partially deacetylated (chitozan), etherified, esterified, carboxymethylated and hydroxyethylated.
• Chitin fibres are obtained by way of wet weaving from a polymer solution, using a solvent matching side groups occurring on the polymer chain.
• the length of the fibres produced is in the range of 3 - 20 mm.
• the proposed linking fibres have a linear mass of 0,1 - 50 d and a length of 0,5 - 150 mm.
• the fleece is produced using the papermaking method. Drying is performed on a roller press, over 3 - 20 minutes and a temperature of 100 - 180°C.
• Patent description JP8092820 (published 1996.04.09) describes a method of producing chitin fibres and membranes. The method is based on producing alkaline chitin with an addition of 10-48%) NaOH, pressing and the addition of carbon disulphide.
• the misture of chitin and its derivatives can be introduced into the wound in the form of pills, a cream or powder.
• Chitin powders or solutions and those of its derivatives can serve as raw materials for the impregnation of surgical gauze, or as underlayers to be placed on wounds.
• the amount of chitin placed on a wound varies between 2 - 10 mg/cm 2 of dressing surface.
• chitin in the form of alkalichitin xanthogenate can be dissolved and converted into fibres, and thence reconstituted into the initial chitin.
• Partially deacetylated chitin filaments and chitin fibres can be transformed according to patent description US2040880.
• Chitin fibres can be used as surgical sutures or as a raw material for the production of woven or non-woven wound dressing materials, according to description US3196075. They can also be transformed into creams or suspensions. Despite the above described studies on the production of wound dressing materials, the application of chitin and its derivatives as wound dressings, there is still a need to produce effective tools facilitating the easy production of wound dressings, the perfection of technological processes and amelioration of the end product. These materials may also be used as medical implants, including in the form of wound dressings or as wound-adjacent layers in composite dressings.
• the goal of the present invention is to deliver means which could be used in the production of wound dressings using dibutyrylchitin and chitin reconstituted from dibutyrylchitin in order to obtain wound dressings characterised by biodegradability in contact with a living organism.
• the realisation of such a stated goal and solving of problems described in the state of the art connected with the production of wound dressing materials facilitating improvement in healing; at the same time characterised by biodegradability on contact with a living organism; the production of preparations enabling the use of dibutyrylchitin as a wound dressing material in therapy have all been achieved the present invention.
• Wound dressings being the subject of the present invention belong to the groups of prophylactic and therapeutic dressings.
• Therapeutic dressings are wound dressings showing medicinal properties in the removal of pathological states in the human organism at the site of their application.
• Prophylactic dressings are wound dressings which prevent the formation of pathological changes in the human organism in areas endangered by such changes.
• a treatment wound dressing will be one applied to bedsores, in order to cure them.
• a prophylactic dressing will be one which will prevent necrosis in cases of blood flow deficiency.
• the subject of the present invention is a wound dressing material, composed of a mixture of synthetic and/or natural fibres, characterised in that it contains at least one
• a wound dressing material contains fibres of at least one compound selected from among dibutylchitin or butylchitin with varying esterification degrees, obtained through the alkaline hydrolysis of ester moieties in dibutylchitin, or chitin reclaimed from dibutylchitin.
• the percentage composition of fibres of at least one compound selected from among dibutylchitin or butylchitin with varying esterification degrees, obtained through the alkaline hydrolysis of ester moieties in dibutylchitin, or chitin reclaimed from dibutylchitin amounts to between 0,1 and 100%>.
• a wound dressing material is saturated and/or coated with a dibutylchitin solution.
• a wound dressing material is saturated and/or coated with a dibutylchitin solution, preferentially a solution containing an organic solvent or a mixture of organic solvents.
• a dibutylchitin solution preferentially a solution containing an organic solvent or a mixture of organic solvents.
• the dry mass dibutylchitin content per 1 m 2 of wound dressing surface represents from 1 to 300%> of the mass of initial wound dressing prior to the application of dibutylchitin.
• a wound dressing material is designed to be used on wounds.
• the next subject of the present invention is a wound dressing composed of a mixture of synthetic and/or natural fibres, characterised in that it contains at least one compound selected from among dibutylchitin or butylchitin with varying esterification degrees, obtained through the alkaline hydrolysis of ester moieties in dibutylchitin, or chitin reclaimed from dibutylchitin
• a wound dressing composed of a mixture of synthetic and/or natural fibres, characterised in that it contains at least one compound selected from among dibutylchitin or butylchitin with varying esterification degrees, obtained through the alkaline hydrolysis of ester moieties in dibutylchitin, or chitin reclaimed from dibutylchitin.
• the percentage composition of fibres of at least one compound selected from among dibutylchitin or butylchitin with varying esterification degrees, obtained through the alkaline hydrolysis of ester moieties in dibutylchitin, or chitin reclaimed from dibutylchitin amounts to between 0,1 and 100%.
• the dry mass dibutylchitin content per 1 m of wound dressing surface represents from 1 to 300%> of the mass of initial wound dressing prior to the application of dibutylchitin.
• it is a clinical dressing.
• it is a prophylactic dressing.
• it is in the form of flakes, a sheet, a drape or a bandage composed of a mixture of synthetic and/or natural fibres.
• it is a dressing for securing a wound surface, particularly against excess non-renal fluid loss.
• the next subject of the present invention is an application of at least one compound selected from among dibutylchitin or butylchitin with varying esterification degrees, obtained through the alkaline hydrolysis of ester moieties in dibutylchitin, or chitin reclaimed from dibutylchitin in the production of wound dressings.
• a mixture of synthetic and/or natural fibres are used in the production of the wound dressing.
• the fibres at least one compound selected from among dibutylchitin or butylchitin with varying esterification degrees, obtained through the alkaline hydrolysis of ester moieties in dibutylchitin, or chitin reclaimed from dibutylchitin are used in the production of wound dressings.
• the percentage composition of fibres of at least one compound selected from among dibutylchitin or butylchitin with varying esterification degrees, obtained through the alkaline hydrolysis of ester moieties in dibutylchitin, or chitin reclaimed from dibutylchitin amounts to between 0,1 and 100%>.
• the fibre mixture is saturated and/or coated with a dibutylchitin solution, preferentially a solution containing an organic solvent or a mixture of organic solvents to obtain 1 to 300% dibutylchitin dry mass per lm 2 in relation to the initial mass of the wound dressing prior to the application of dibutylchitin.
• a dibutylchitin solution preferentially a solution containing an organic solvent or a mixture of organic solvents to obtain 1 to 300% dibutylchitin dry mass per lm 2 in relation to the initial mass of the wound dressing prior to the application of dibutylchitin.
• dressings composed of the fibres of at least one compound selected from among dibutylchitin or butylchitin with varying esterification degrees, obtained through the alkaline hydrolysis of ester moieties in dibutylchitin, or chitin reclaimed from dibutylchitin secure a wound surface against excess non-renal fluid loss.
• the next subject of the present invention is a method of producing a wound dressing from a mixture of synthetic and/or natural fibres, characterised in that the material is saturated and/or coated with a dibutylchitin solution.
• the material is saturated and or coated with a solution of dibutylchitin in an organic solvent or a mixture of organic solvents.
• the material is saturated and/or coated with a solution of dibutylchitin in an organic solvent to obtain from 1 to 300% of dibutylchitin dry mass per lm 2 in relation to the initial mass of wound dressing prior to the application of dibutylchitin.
• the material with an applied layer of dibutylchitin is set aside to allow the solvent or mixture of solvents to evaporate.
• the material with an applied layer of dibutylchitin is immersed in a coagulation bath containing a coagulant, until such time as it solidifies and is dried.
• the material with an applied layer of dibutylchitin is additionally processed in alkali following the removal of solvent or mixture of solvents.
• the material contains a layer of butylchitin estrified between 10% and
• the material contains a layer of chitin reclaimed from dibutylchitin.
• an electrostatic field of 2 to 35 kN is applied during the formation of fibres using the electroweaving technique, where the solidified fibres are accumulated on the collecting electrode.
• the fibres or fibrous material composed of dibutylchitin is transformed into fibres of fibrous material composed of reconstituted chitin, using alkaline hydrolysis.
• a solution of polymer in an organic solvent or mixture of organic solvents is used during the formation of fibres using the spraying technique.
• the solidification of the polymer is carried out at a temperature higher than the evaporation temperature of the solvent or solvent mixture.
• polymer solidification is carried out in a coagulation bath.
• the next subject of the present invention is a method of producing a wound dressing characterised in that the in the production of the wound dressing hydrolysis of dibutyrylochitin to chitin is used.
• the reconstituted chitin content following hydrolysis amounts to 1 -
• the hydrolysis is performed in a hydrolysing bath in the presence of 0,1 -
• the hydrolysis is performed in a hydrolysing bath in the presence of 1-
• the temperature is between 20°C and 100°C.
• the time of hydrolysis is 10 to 5h.
• the next subject of the present invention is a method of producing a wound dressing in the form of flakes, sheet, drape or bandage from a mixture of synthetic and/or natural fibres, characterised in that the material is saturated and/or coated with a dibutylchitin solution.
• the material is saturated and/or coated with a dibutylchitin solution in an organic solvent or mixture of organic solvents.
• the material is saturated and or coated with a dibutylchitin solution in an organic solvent or mixture of organic solvents to obtain between 1 and 300% of the dibutylchitin dry mass per lm 2 in relation to the initial wound dressing mass prior to dibutylchitin application.
• the material with an applied dibutylchitin layer is set aside to allow the solvent or mixture of solvents to evaporate.
• the material with an applied layer of dibutylchitin is immersed in a coagulation bath containing a coagulant until such time as it solidifies and is dried.
• the material with an applied layer of dibutylchitin is additionally processed in alkali following the removal of solvent or mixture of solvents.
• butylchitin estrified between 10% and 95% is used, which is obtained through the alkaline hydrolysis of ester moieties in dibutylchitin.
• chitin reconstituted from dibutylchitin is used.
• the next subject of the present invention is a method of producing a wound dressing characterised in that the electroweaving or polymer solution spraying techniques are used in the production of a wound dressing containing dibutylchitin.
• an electrostatic field of 2 to 35 kN is applied during the formation of fibres using the electroweaving technique, where the solidified fibres are accumulated on the collecting electrode.
• the formed dibutylchitin fibres or fibrous material is transformed into butylchitin fibres of fibrous material estrified between 10%> and 95%o or reconstituted chitin, obtained through the alkaline hydrolysis of dibutylchitin.
• a solution of polymer in an organic solvent or mixture of organic solvents is used during the formation of fibres using the spraying technique.
• the solidification of the polymer is carried out at a temperature higher than the evaporation temperature of the solvent or solvent mixture.
• polymer solidification is carried out in a coagulation bath.
• Figure la represents a micrograph of deep skin lesions bandaged with a polypropylene dressing covered with dibutyrylchitin 7 days after the operation. A scab is visible at the top. Below the scab is freshly formed epithelium, and below it is lattice-like connective tissue with many cells. HE staining, mag. 120 x
• Figure lb represents a micrograph of deep skin lesions bandaged with a polypropylene dressing covered with dibutyrylchitin 14 days after the operation. On the left is a strip of epithelium covering granular tissue. HE staining, mag. 120 x
• Figure lc represents a micrograph of deep skin lesions bandaged with a polypropylene dressing covered with dibutyrylchitin 21 days after the operation.
• On the left is a strip of epithelium covering fibrous tissue.
• Figure 2a represents a micrograph of deep skin lesions bandaged with a polypropylene dressing covered with chitin 7 days after the operation.
• On the right is a skin fragment with migrating cells.
• On the left is a scab, below which is newly formed epithelium.
• Figure 2b represents a micrograph of deep skin lesions bandaged with a polypropylene dressing covered with chitin 14 days after the operation. Young connective tissue covered with epithelium is visible.
• HE staining, mag. 120 x mag. 120 x
• Figure 2c represents a micrograph of deep skin lesions bandaged with a polypropylene dressing covered with chitin 21 days after the operation. Connective tissue covered with epithelium is visible. HE staining, mag. 120 x
• Figure 3a represents a micrograph of deep skin lesions bandaged with a gauze dressing (control) 7 days after the operation. Skin fragment with lesion.
• Figure 3b represents a micrograph of deep skin lesions bandaged with a gauze dressing (control) 21 days after the operation. On the left is connective tissue covered at the edge with epithelium, which is lacking in the center.
• Figure 4a represents an image of a wound prior to the application of a flake composed of 100% dibutyrylchitin fibres.
• Figure 4b represents an image of a wound following the application of a flake composed of 100% dibutyrylchitin fibres.
• Figure 4c represents the healing process of a wound bandaged with flakes of dibutyrylchitin fibres.
• Figure 4d represents a wound following treatment with a dibutyrylchitin dressing.
• Figure 5a represents a wound prior to the application of a dressing composed of 100% dibutyrylchitin fibres.
• Figure 5b represents a wound prior to the application of a dressing composed of 100% dibutyrylchitin fibres.
• Figure 5c represents a wound following the application of a dibutyrylchitin flake.
• Figure 5d represents a healing wound following the application of a dibutyrylchitin flake.
• Figure 5e represents a wound during healing.
• Figure 6a represents a wound following the demarcation of necrotic tissue.
• Figure 6b represents a wound following the application of dibutyrylchitin flakes.
• Figure 6c represents healing under a dibutyrylchitin flake.
• Example 1 A method of producing a wound dressing material using the polymer spraying technique
• a 10%) dibutyrylchitin solution in ethanol was heated to 22°C and forced through a weaving nozzle with a 0,4 mm bore.
• the polymer temperature in the mixer was 22°C, whereas the pumping temperature (nozzle temperature) was 25°C.
• the nozzle was 2 m from the receiving surface.
• Technological air at 25 °C was blown on the polymer strands. The air flow was applied at 36 d Vs, and the polymer at 9,5 c Vs.
• the polymer was placed in a coagulation bath coagulation bath (water).
• the last stage consisted of drying in a drier at 100°C for 2 min.
• a fleece was obtained of fibres 0,053 mm thick on average and a high fibre thickness variability (ca. 45%).
• the fibrous tissue obtained had a mass per surface area of 20 g/m 2 and had an absorption capacity of 0,02 g/g and sorption rate of 0,36 g/g-s.
• Example 2 A method of producing a wound dressing material using polymer solution spraying
• Such a weaving solution was heated to 25°C and forced through 0,4 mm bore nozzles.
• the pumping temperature (nozzle temperature) was 30°C.
• the nozzle was 2 m from the receiving surface. Air at 22°C was blown on the polymer strands at 40 dmVs, and the polymer at 23 cm 3 /s.
• the polymer was completely solidified in a coagulation bath coagulation bath (water).
• a fleece was obtained with fibres 0,09 mm thick on average and a thickness variability of 45%>.
• the fibrous tissue obtained had a mass per surface area of 38 g/m 2 and had an absorption capacity of 0,021 g/g and sorption rate of 0,40 g/g-s.
• Example 3 A method of saturating a prophylactic wound dressing material with a dibutyrylchitin solution.
• a polypropylene fibre mat with a mass per surface area of 30 g/m produced with the direct polymer solution spraying was washed in distilled water with a surface-active additive. After wringing, the fibre mat was washed several times in distilled water, and then in ethanol.
• the prepared fibre mat was inserted into the enhancing bath containing the dibutyrylchitin solution in acetone, at ambient temperature. Excess polymer solution was removed with a roller press with a force of 0,7129 N/cm. The sample was dried at ambient temperature.
• a prophylactic wound dressing material was obtained, with a d.m. dibytulchitin content of 35,71%. The material obtained was stiffer than the initial material.
• Example 4 A method of coating a wound dressing material with a dibutyrylchitin solution
• the 4% dibutyrylchitin solution in ethanol was applied to a transfer tissue at a level to ensure 10 g/m 2 of dibutyrylchitin and air-solidified at ambient temperature.
• the foil obtained was coated with the same dibutyrylchitin solution at 5 g/m 2 .
• a polypropylene fibre mat with a mass per surface area of 17 g/m 2 was applied to the unsolidified polymer layer. The system was left to evaporate at ambient temperature.
• the material obtained was characterised by a higher flexibility and higher permeability to water than that obtained in Example 3.
• a woven fibre mat, 60g/m 2 ' composed of DBC fibres was hydrolysed in Sodium base.
• the mat fibre was introduced into the bath between two teflon meshes, and the hydrolysis was performed at 22°C.
• the NaOH concentration in the bath was 4,9%>.
• the hydrolysis was performed in two bouts of lh 40min.
• the fibre mat was rinsed in distilled water, until such time as the bath water was of neutral pH, and the fibre surface was also neutral.
• the fibre mat obtained was composed of chitin and dibutyrylchitin with a pure chitin concentration of 20%>.
• the mass per surface area after hydrolysis was 21,7g/m 2 .
• a polypropylene fibre mat with a mass per surface area of 30 g/m 2 produced by the direct polymer solution spraying technique was washed in distilled water with a surface active additive. After wringing, the fibre mat was washed several times in distilled water, and then in ethanol.
• the prepared fibre mat was inserted into the enhancing bath containing the dibutyrylchitin solution in acetone, at ambient temperature.
• the prepared fibre mat was inserted into the enhancing bath containing the dibutyrylchitin solution in acetone, at ambient temperature.
• Example 7 A method of producing a wound dressing material using electroweaving
• the fixed tissues were sectioned along the wound diameter, and the sections thus obtained underwent standard histological preparation: dehydration in an acetone series, xylene saturation and paraffin imbedding.
• the histological slides were stained with haematoxylin and eosin according to van Gieson and Mallory.
• Example 9 Clinical trial Case 1. Open fracture of the left tibia with a skin abscess in a boy, 10 years old. Operative treatment was successful, leaving a partial wound with a bare tibia at the bottom of the wound. Following the application of a bandage containing only dibutyrylchitin fibres, the would underwent autoregeneration. The treatment process is outlined in Figs. 4a - 4d.
• Materials composed of pure dibutyrylchitin and reconstituted chitin, obtained via methods according the present invention can biodegrade completely or partially in contact with a living organism, i.e. in the form of wound dressing materials or as the lesion-adjacent layer of a composite wound dressing.
• Materials composed of dibutyrylchitin were evaluated at the Department of Experimental Surgery Biomaterial Trials of the Medical Academy of Wroclaw. The trials were performed in accordance with the European Norm ISO 10993 -headedBiological evaluation of medical products". It was determined that all parameters were evaluated within norms, and that they adhere to the standards. With the permission of the Medical Ethics Committee, the influence of the materials produced according to the present invention on various types of wounds on the human body. It was determined that they do not cause any side effects, and in 8 cases out of 11 show a tendency to accelerate healing and biodegrade, as shown in the enclosed figures.

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