Wound shield

FIELD: medicine.

SUBSTANCE: invention refers to medicine, more specifically to a wound shield for wound healing in a humid or humid-moist medium containing a suction and washing body made of a fibre nonwoven fabric, wherein a superabsorbent material is distributed; during the process, the suction and washing body is impregnated with a saline solution, particularly Ringer's solution, preferentially until saturated, and a coating forming outer visible sides of the wound shield; a film layer can be applied from the side of the suction and washing body. The wound shield comprises a cationic substance of microbial action, which is attracted by negative groups of the anionic superabsorbent material, and thereby has antimicrobial action inside the suction and washing body; from the side facing the wound, the coating is provided with an outer partial structured non-traumatic coating (16) having the coverage of no more than 70%.

EFFECT: wound shield prolongs the replacement-free period.

14 cl, 3 dwg

 

The invention relates to a wound cover for the treatment of wounds in a moist or wet wet environments containing position suction and flushing the body on the basis of fibrous nonwoven material, which includes distributed superabsorbent material, and position suction and flushing the body in the process of making impregnated with a salt-containing aqueous solution, in particular ringer's solution, preferably to saturation, and forming the outer visible side of the wound the lining membrane, facing away from the wound-facing position suction and flushing of the body may be provided for preventing the evaporation of the film layer.

The wound pad of this type is known from patent document EP 0594034 B1 of the applicant of this invention. When it comes to the wound cover according to the type of wound pads or wound compress, which may be superimposed on the wound or can be used for the plugging of deep wounds. In the manufacturing process position suction and flushing the body is preferably impregnated to saturation salt-containing aqueous solution, which causes swelling of the superabsorbent material and its transition to the gel state. This gives a position suction and flushing the body of the dual function at wounds wound with copious secretions. Wound allocation, including critical components such as the microbe�, actively accepted position suction and flushing the body and cling to him, in this position suction and flushing the body counter gives the wound with salt-containing aqueous solution and thus creates and maintains a moist wound environment. This facilitates the cleaning of the wound and its positive conditioning and, thus, positively affect a cure. The issue here is interactive wet therapy, which is preferably finds application in badly healing wounds, when clearly clinically infected wounds or chronic wounds of different origin, such as diabetic gangrene, pressure sores or ulcers.

In the typical case under ringer's solution refers to an aqueous solution with sodium chloride, potassium chloride and calcium chloride (in particular, 8.6 g NaCL, 0.3 g KCL, and 0.33 g CaCl per liter).

The time period between replacements of wound pads, that is the time one wound pads to the nearest replacement pads should be at least 24 hours, and strive to increase the time period between replacements, in particular, to the period from 48 to 72 hours. This is desirable both in the economic aspect, and due to the fact that frequent changing of wound pads disrupts the healing process of the wound. On the other hand, in this case, there is a risk of deterioration of the conditioning of the wound, so�there is still critical for RAS time period between replacements of overlays in an interactive wet therapy was maintained in the field 24 hours.

The present invention is the improvement of wound pads of the type described in relation to optimization of air-conditioning wounds and, in particular, on the possible lengthening of the period of time between replacements of the overlay.

In accordance with the invention in the wound pad of the specified type solution to the problem is achieved by the fact that aqueous solution at pH values of from 4 to 7.5 typical wet or wet to wet wound environment contains a cationic substance antimicrobial action, which is attracted by the negative groups of the anionic superabsorbent material, and thus acts antimicrobial inner position suction and flushing of the body, while the shell is turned on to the wound side provided with an outer partial structured coatings nontraumatic action with coverage greater than 70%.

Till now in position suction and wash the bodies of the wound pad is not used substances antimicrobial action, because he wanted to keep the wounds essentially free from such substances or deliberately introduced into the wound antiseptic. However, in accordance with the invention it was found that the use of cationic antimicrobial substance actions bind and hold negative groups�mi characteristic Central antimicrobial highly absorbent materials so they are also in use position suction and flushing the wound body lining according to the invention in a damp or wet-wet wound environment remain largely inside position suction and flushing of the body, i.e. do not penetrate into the wound or penetrate into it slightly. This excellent position suction air conditioning-washing of the body can be achieved even when applying for more than 24 hours. In turn, this positively affects the conditioning of the wound environment as the position suction and flushing of the body to exchange fluids from optimally protivomikrobnye position suction air-conditioned-washing of the body in the wound penetrates the liquid, however, this wound essentially do not penetrate back septic substance exposure or germs. Thus, essentially eliminates infection return.

By coating non-traumatic operation, partly deposited and structured on facing the wound-facing unforeseen supports better exchange of fluids through available coverage from the field, as bounding areas with non-traumatic coating prevents solid flat coupling between shell wound of the lining and tissue of the wound due to the fact that the area coated with non-traumatic perform the hold function on R�sostoyanii. This leads to a better exchange of fluids in General, which in interaction with cationic antimicrobial substance of the action inside position suction and flushing of the body helps in the healing of wounds, such as wound allocation/exudates from microbes can in larger quantities to get into position suction and flushing the body and there subjected to antimicrobial treatment.

The concept of "partially structured coatings" implies that it is not a solid surface coating, and is a porous coating, which may be implemented e.g. by means of dots, Islands, lines, streaks, or other related or unrelated entities.

Preferably anionic superabsorbent material is a polymer, in particular based on the polyacrylate. According to another exemplary embodiment of anionic superabsorbent material is a polysaccharide, such as starch, or a derivative of a polysaccharide, for example carboxyethylgermanium polysaccharide, as described in patent document WO-A-2008/037062.

Cationic antimicrobial substance actions can be, for example, substances with amino groups or aminopropane that in the solution with pH from 4 to 7.5 are charged cation. Further, the cationic substance may be metal cations anti�mikrobnogo operation, in particular cations of silver, for example the complex of 1-vinyl-2-pyrrolidon with silver cations. Particularly suitable cationic antimicrobial substances are derivatives, biguanides, such as chlorhexidine, or polybiguanide, such as polyethylenimine (REV), polytetramethylene (RTPS) or polyethyleneeterephthalat (REMV). Especially preferred polybiguanide is polyhexamethyleneguanidine (RNPS or polihexanide). Other suitable cationic substances antimicrobial action are polyguanidine, such as polyhexamethyleneguanidine (PHMG), N-octyl-1-[10-(4-actionoverride-1-yl)decyl]pyridin-4-Yiming (octenidine), Quaternary aminosilane, such as benzalkonium chloride or cetylpyridinium chloride, triazine, such as 1-(chloroallyl)-3,5,7-triaza-1-isonicotinate chloride or ammonium compounds, taurolidine.

The concentration of the additive antiseptic action in aqueous solution, which is used to activate dry position suction and flushing of the body, is preferably from 0.06 to 0.20 mass%, more preferably from 0.08 to 0.15 mass%, even more preferably from 0.10 to 0.15 wt.% (relative to the solution before activating position suction and washing of the body).

As indicated above, due to the choice of substances to its antimicrobial effect in collaboration with superb�orbitowskim material is achieved the effect what this substance even in the application of wound pads mainly or predominantly remains within position suction and flushing the body. This can be visually checked or verified based on the test zone of suppression or inhibition (growth of microbes in a dense environment). During the test zone of inhibition which will be described next, can be visually checked, getting out of a test body in substantial amounts kills the germs substances or not. If they come, they kill or inhibit the growth of so-called colony forming communities in the test environment of the body that can be set visually by inspection of the test body and the surrounding fields. If this setting is no, that is not subject to suppression zone (or zone of inhibition), this means that of the test body does not appear in appreciable amounts of substances which inhibit the growth of colonies. In continuation of the characteristics of the present invention, the wound cover further characterized in that the test zone of inhibition (growth of microbes in a dense environment) output cationic substances antimicrobial action of wound pads visually is not installed. This means that when conducting the test described later are not visually zone of inhibition (growth of microbes on the dense media�).

The test zone of inhibition (growth of microbes in a dense environment)

To perform the test zone of inhibition (growth of microbes in a dense medium) wound pad of the specified type here is placed on the prepared agar plate. This is done using agar plate with a diameter of 8.5 cm, containing 15 ml Caseinate-soperton-agar (concentration of Caseinate-soapstone: 40 g/l). On this agar plate with a cotton swab applied 10 µl of microbial suspension of Staphylococcus aureus ADS 6538 (about 5×106forming colony units/ml), and dried for 10 to 15 minutes. After drying of the microbial suspension under a closed lid sterilized, but cooled to a room temperature of the test body in the form you want to test wound pads are placed on agar plate facing the wound side (position 8 in Fig.1). Next, the plate was incubated without rotation position for 18 hours at 35°C. After that, the agar substrate is visually inspected for the formation of a zone of suppression. In the typical case, the zone of inhibition measured in millimeters using the formula N=(D-d) 2, where D is the overall diameter of the test body and the zone of inhibition, a d - diameter of the test body in millimeters. In that case, when the zone of inhibition around the test body is not visually set (D=d and N=0), this means that according to the test zone �of davleniya not set the output of any substances from the tested body and their effects on the growth of the colonies.

In a preferred embodiment of the composition position suction-rinsing body can contain: superabsorbers material described above in an amount of from 120 to 170 g/m2, the cellulose fibers in an amount of from 120 to 170 g/m2and, in particular, thermoplastic fibers in an amount of from 5 to 18 g/m2. Additionally on one or both sides may be a woven layer. Position suction and flushing the body may consist of the above components (and optionally salt-containing aqueous solution).

In respect of the longer period of time between replacements is essential that in position suction and flushing the body enough fluids during the whole time of its application, that is, until the next change to enable it to perform really effectively mentioned at the beginning of the dual function. To do this, during application of the wound lining the evaporation of the liquid must be kept within acceptable limits. In this respect showed itself as the preferred solution, when the shell facing away from the wound side contains non-woven material pasted on the outer side of the film layer that forms prevents the evaporation of the film layer. It was found that this can be significantly reduced evaporation compared with the known wound pads with W�protective films placed or laid on the inside of the shell facing away from the wound side.

Preferably, the nonwoven material is a polyolefin non-woven material, in particular polypropylene non-woven material.

Preferably the shell for facing the wound side, but also facing away from the wound side of the wound pads, may be formed of a textile flat material, in particular a knitted fabric, a knitted fabric or cloth, in particular of polyolefin, in particular polypropylene. In any case, the application of membranes in the form of a flat textile material, in particular in the form of knitted fabric, knitted fabrics or cloth, on facing the wound side is preferred for the exchange of fluids, that is, the double-function position suction and flushing of the body.

The above mentioned positive aspects and partially structured coatings non-traumatic operation, namely, that it prevents the bonding with the wound tissue and performs the hold function at a distance, especially good are achieved by a silicone coating. When the coating of antimicrobial action in the form of silicone deposited on the textile flat material, as already mentioned, is created especially preferred in terms of flexibility, wearability and effectiveness�and combined material.

Further, the preferred proved to the degree of coverage and partially structured coatings nontraumatic steps from 40 to 70%, more preferably from 40 to 60%, more preferably from 40 to 55%, more preferably from 40 to 50% of the area under consideration is drawn to the wound shell.

Preferably, the elevation coverage in the Z direction above the plane of the outer side of the shell is from 0.03 to 0.5 mm, more preferably from 0.1 to 0.4 mm, more preferably from 0.1 to 0.3 mm, more preferably from 0.1 to 0.2 mm.

Preferably and structured partially coated with non-traumatic actions has size at least in one direction of the plane not more than 4 mm, more preferably not more than 3 mm, and further preferably from 1 to 3 mm, more preferably from 2 to 3 mm.

Preferably the distance between adjacent areas of the coated surface is at least 1 mm and not more than 5 mm.

In the follow position suction and flushing of the body on the basis of fibrous nonwoven material has shown itself to be the preferred solution, when used cellulose fibers, preferably cellulose fibers air laying, or preferably an air-laying of a mixture of cellulosic fibers and thermoplastic fibers, in particular polyolefin fibers, in particular fibers of polypropylene or polypropylene/polyethylene fibres which preferably form a common fiber-based position suction and flushing the body. The proportion of thermoplastic fibers in such fiber mixture is preferably from 5 to 10% of the share cellulose fibers.

In addition, proved to be the preferred solution, when the specific area of the evaporation rate in the time interval from 24 to 72 hours after simulated wound overlay overlay is less than 0,020 g/24 h·cm2preferably less than 0,017 g/24 h·cm2, more preferably less than 0.015 g/24 h·cm2, more preferably less than 0.012 g/24 h·cm2. This is done using the following test method.

Test method for rate of evaporation

To determine the rate of evaporation is initially Packed in impermeable to water vapor packing of the wound pad 20 (Fig.2) is removed from the packaging. It contains position suction and flushing the body on the basis of fibrous nonwoven material, in particular material Favor of the RAS 300 firm Evonik Stockhausen GmbH, and in certain cases also of thermoplastic fibers. Before laying impervious to water vapor packing of the wound pad 20 will activate the salt-containing aqueous solution, particularly ringer's solution. Next, the wound pad 20 placed her facing the wound side (position 8 in Fig.1) impermeable to water vapor packaging �Lenka 22 (see Fig.2), and its circumferential edge region 24 of the cover film 26 and thereby fix the wound pad relative to the substrate (simulated wound overlay overlay). For this film 26 (e.g. film brand Opsite flexiflix) spread on the wound pad 20 and in the middle of the cover film 26 having holes 28, so that a large portion of the surface 30 of wound pads 20 is open to the environment and only the circumferential edge region 24 a width 5 mm remains covered with the cover film 26. Thus, the largest portion facing away from the wound side of the wound lining 20 is open to the environment, so adopted the position suction-rinsing body fluid can evaporate through the surface. The sample is left at a temperature of 23°C and 50% relative humidity and weighed at certain points of time, namely t=0 h, t=24 h t=48 h and t=72 h. By comparing the mass can be obtained in the evaporation rate in g/24 h or in g/24 h·cm2. The latter quantity is the specific rate of evaporation per unit area of the exposed surface.

Showed himself preferred when the specific rate of evaporation per unit area within the first 24 hours after simulated wound overlay overlay is less than 0.050 g/24 h·cm2fluid, preferably less 0,037 g/24 h·cm2fluid, more preferred�flax is less than 0.025 g/24 h·cm 2fluid.

Other features, details and advantages of the invention will become apparent from the claims, the attached graphic materials and the subsequent description of preferred exemplary embodiment of the wound lining according to the invention.

In the drawings:

Fig.1 wound pad according to the invention is schematically shown in cross section;

Fig.2 shows a system for carrying out tests to determine the rate of evaporation;

Fig.3 shows the measurement result.

Fig.1 wound pad 2 shown in cross section. It includes position suction-rinsing body 4 on the basis of fibrous nonwoven material. Preferably, the fibrous base is a mixture of cellulose fibers by air stacking (cellulose) and polypropylene or polypropylene/polyethylene fibers. These fibrous mixture are superabsorbent polymer material (SAP). "superabsorbent polymer") in the form of particles or in the form of fibers as far as possible homogeneous, with a Central antimicrobial highly absorbent materials in the total mass position suction and flushing of the body preferably is from 40 to 50 wt.%. The average particle size of the superabsorbent material is, for example, from 150 to 850 μm (for example, polyacrylate brand Favor races 300 firm Evonik Stockhausen GmbH).

Position suction-rinsing body 4 enclosed in forming the outer� side of the wound the lining membrane 6, which is formed facing the wound layer 8 of the casing and facing away from the wound layer of the shell 10, connected to each other at the lateral edges. Facing the wound the shell layer 8 is preferably a knitted fabric, preferably made of polypropylene. It may also use fabric or knitted fabric, that is, the shell layer of filaments or elementary fibers with a textile connection, which ensures a good exchange of fluid between position suction-rinsing body 4 and the wound environment.

Facing away from the wound layer of the shell 10 is formed of a flat combined material or a multilayer material, such as nonwoven material 12, preferably of polypropylene, and glued over it with a waterproof film 14, which covers the whole flat length of nonwoven material 12 and forms for facing away from the wound side is significantly better protection from evaporation.

On facing the wound with the outer side facing the wound layer 8 is partial and structured applied nontraumatic coating 16. This coating preferably is a silicone coating, and it is porous and is presented as an example case is formed by a multitude of relatively thin strips or lines or forming Islands areas, separated from each other by areas b�W coating. In these areas without coating facing the wound layer 8 of the shell is open to the wound. Nontraumatic active coating 16 forms against the protrusion or elevation, the magnitude of which is specified in the introductory part of the description. Due to this, on the one hand, can be prevented bonding layer 8 of the shell with an injury and, on the other hand, can persist for a relatively small distance between the shell layer and wound tissue, whereby the porous material layer of the shell remains spatially open and has a low resistance to the passage of fluid in both directions throughout the period of use of the wound overlay.

Further, the wound pad 2 has the perimeter edge, which is formed by two welded with each other by layers 8, 10 shell. However, wound pads are cut in such a way that this edge can essentially be neglected. Described above nontraumatic active coating 16 is applied not on the endless flat material layers of the shell, and only after the last welding process, in particular, after the separation of the wound overlays as separate products, i.e. after the corresponding position suction-rinsing body 4 is placed between facing the wound layer 8 of the casing and facing away from the wound by a layer of shell 10 and is fixed by means of the connection layer 8, about 10�points. Constructed system products or have already separated cut products further and structured partially coated with a coating material, preferably one-component silicone, from the exhaust system as described above. For this purpose, a measuring device with a precision exhaust nozzle needle comprising a controllable open and close the valve. The metering device is controlled by a system management software with the ability to move in the directions X and Y, and preferably also in the direction Z. in This way it can be achieved partial and structured application, in particular, with given input parameters for compliance with the dimensions and elevation is provided with a coating surface areas.

Only after this position suction and flushing the wound body 4 pads according to the invention is treated with a salt-containing aqueous solution, in particular ringer's solution, preferably to saturation. This salt-containing solution is a substance of antimicrobial action, which in damp or wet to wet wound environment at pH values from slightly acidic to neutral region, which range from 4 to 7.5, contains a cationic substance. This cationic antimicrobial substance actions attracted negative anionic groups Central antimicrobial highly absorbent mater�Alov thus, even when working position suction-rinsing body 4 on the exchange of liquid substance remains bound to the Central antimicrobial highly absorbent material that is generally not given in a wound environment. This prevents the proliferation of germs brought into position suction-rinsing body 4 of the wound secretions, so essentially prevention of re-infection in the direction toward the wound. It was found that such microbiological reverse the infection can be prevented for more than 72 hours. This is because the substance of antimicrobial action due to its cationic state is evenly distributed inside position suction-rinsing body 4 and is retained in the bound state superabsorbers materials.

In a preferred example of the composition of wound pads 2 basis of fibrous nonwoven material position suction-rinsing body 4 consists of 127 g/m2cellulose fibers (pulp) and 8 g/m2polypropylene/polyethylene fibers as binder fibers (in particular, E-505/FV firm Schwarzwalder). This mixture of fibers are uniformly mixed to 127 g/m2the above Central antimicrobial highly absorbent materials. The thus obtained mixture of fibrous non-woven backing + superabsorbent materials), which forms a position suction-rinsing body 4, can be surrounded on ka�DOI pulp side of the woven layer, in particular, with a mass per surface unit, for example, 8 g/m2(diaper cloth Diaper Tissue 1800 from the manufacturer Swedish Tissue AB) (not shown); however, it is not mandatory. Wound pad may be formed, for example, round, for example, with dimensions position suction-rinsing body 4, essentially corresponding to the size of the wound pads 2 with a diameter of 5.5 cm. In conclusion, the wound overlay activate ringer's solution in the amount of 13.6 ml, which essentially corresponds to the saturation position suction-rinsing body fluid. The shell 6 is formed, as described above. In such a wound pad 2 modeled after the overlay was determined evaporation rate within the first 24 hours, equal to 0.19 g/24 h. Here, the preferred upper limit is 0.8 g/24 h, more preferably 0.6 g/24 h, even more preferably 0.4 g/24 h. In the next period of time from 24 hours to 72 hours evaporation was 0.16 g/24 h. Here, the preferred upper limit is 0.3 g/24 h, more preferably 0.2 g/24 h.

Measurement of the force of separation

Indicated that the ability to the separation or removal of wound pads from injury when replacing pads is a very important property, since the adhesion or sticking to the bottom of the wound leads to pain in the separation and the new DNA damage �Ana. Described below to measure the force Department should provide the ability to determine trends in bonding with the bottom of the wound and conclusions about the ability to the separation or removal of wound pads from injury.

As a measure of the ability to the separation or removal is the measurement of the force of separation between the textile substrate and the gelatin. The textile substrate is concerning the wound textile outer layer of wound pads, and gelatin is supposed to mimic the wound environment or the surface of the skin.

Prepared 20% aqueous solution of gelatin (soak for approximately 1.5 hours at 60°C to dissolve the gelatin); about 100 ml of the solution was poured into a Petri dish (12 cm × 12 cm). After 30 minutes of cooling due to the test samples (the size of 2.5 cm × 10 cm) placed in a Petri dish on gelatin and prigruzhajut goods (20 mm × 90 mm, 4.2 g). Further, by gelatin incubation of the plates for 3 hours at a temperature of 36°C and 50% relative humidity. Before measuring the strength of the gelatin plate klimatiziranu for 1 hour at 23°C and 50% relative humidity.

To measure the strength of the branch corresponding end of the specimen is slightly separated from the gelatin of the bed and extend duct tape. A Petri dish and the end of adhesive tapes filled to the holders of the testing machine tagou�e force and then measure the force of separation. Pulling in a machine for testing the pulling force is approximately vertical, while the corresponding gelatin plate/Petri dish is horizontal. Determine the average force of the offices along the path of measurement.

Fig.3 shows the measurement results on the following samples: the power of separation was determined on polypropylene knitted fabric, the area of which was covered with silicone to 40%. Silicone was applied to a point.

As comparative samples used polypropylene knitted fabric without coating and dressing of gauze.

From the graph it is noticeable that as the shell position suction and flushing the body on facing the wound side polypropylene knitted fabric coated with silicone rubber is suitable much better than gauze dressing or polypropylene knitted fabric without coating.

Observations on application

The applicant performed a clinical observation of the use of wound pads according to the invention. Wound pad had the composition described above with non-traumatic coating in the form of silicone with dot structured application and the degree of coverage of 40% converted to the wound area of the layer 8 of the shell. Salt-containing aqueous solution position suction-rinsing body 4 was a ringer solution containing 0.1 wt.% RNPS as cationic substances of proteomics�training actions.

Observation on the application covered the period of time from the initial survey E when you first apply wound lining up to final inspection And replacement of wound pads. In the intervening time there were two additional substitutions of wound pads.

The initial survey was conducted on 66 patients. For each patient was scheduled documentation on the three following each other replacements of wound pads. By the time the first replacement of wound pads 3 patients were not available for observation. By the time the second replacement of the wound overlay 4 patients were not available for observation. The final observation was conducted on 59 patients. However, despite this, attempts were made to obtain a final conclusion about the products and then bring them to the assessment. For a final conclusion about the products in the order data was available for 63 patients.

Of patients 50% (33 persons) were men and 50% women.

The mean age of patients was approximately 75 years. The average weight of patients was about 77 kg, min 43,5 kg and a maximum 122,0 kg, median 78 kg. the Average increase amounted to 1.69 m, a minimum of 1.48 m, a maximum of 1.92 cm, median 1.68 m

The causes of RAS were as follows:

ReasonNumberProportion (%)
The venous stasis ulcer1015,2
Ulcer trophic arterial69,1
Ulcer trophic misc1015,2
Bedsore1928,8
Bedsore diabetes913,6
Diabetic gangrene46,1
Traumatic wound34,5
Other57,6

At the beginning of treatment the wounds were on the average length of 5,26±3,09 cm (minimum 0.5 cm, a maximum of 16.0 cm, average 5.0 cm) and a width 3,94±2,08 cm (minimum 0.3 cm, a maximum of 10.0 cm, medium, 4.0 cm). In one case, data on the size of the wound was not.

For 58 RAS had additional data on the depth of the wound. The average depth of the wound was 0,93±0.1 cm (minimum 0.1 cm, max 5.5 cm, environments�Yaya 0.5 cm).

Other injuries were superficial.

At the beginning of the observation prescription wounds were averaged 1.3±3.5 years (minimum 0 days, with a maximum of 20.0 years, an average of 4.0 months). In 7 patients the data on the old wound was not.

6 wounds (9.1 per cent) did not give discharge, 19 (28.8 per cent) were given a small allocation, 28 (42.4 per cent), moderate allocation, 12 (18.2 per cent) strong and 1 (1,5%) very strong selection.

12 RAS (18,2%) first observation had signs of infection.

The time periods between replacements pads: the following table shows the periods of time between replacements of the pads and the total duration of the observations for use in the day. This does not account for patients who due to a period of time between the confirmed documents pads replacements could assume that we are not talking about replacements, following one after another.

from E to 1. VW1. VW to 2. VW2. VW to Afrom E to A for all patients*from E to A 3 VW**
Average2,59±0,932,64±0,942,71±0,87Of 7.48±2,457,80±2,36
Minim�m 11133
High6651212
Average33389

E - the initial examination, VW - replacement pads A - final examination

The symbols in the table:

E=initial survey, VW=replacement pads, A=final examination

* from E to A for all patients: there were included also patients, the observation of which were finished prematurely after the first or second replacement pads.

** E through A 3 VW: here were also taken into account the patients, the observation of which were completed according to plan after the third replacement of the overlay.

Pain when replacing pads

The following table presents the number of patients experiencing pain when replacing pads.

Initial examination1. Replacement ther�Ki 2. Replacement padsFinal examination
Number%Number%Number%Number%
Without pain3147,03657,13661,03657,1
Light for pain1522,71727,01525.4 mm21A 33.3
Average pain1624,2711,1610,157,9
Severe pain4 6,134,823,411,6

A significant improvement in the feeling of pain when you replace the pads between the time of the initial survey and the time of the final survey in accordance with the invention is also due to a better ability to the separation/removal of wound lining from injury. In turn, this is due to the interaction of the components of wound pads and overall positively supports the healing of wounds.

The ability to remove wound lining

In 95,3% of cases of wound pad is amenable to removal from the wound, "very good" (48.4 percent) or "good" (46,9%). As a matter of being able to remove important and may also depend on the duration socks wound pads, the ability to remove was checked after each replacement pads. In this case the removal of wound pads not had any problems. However, it was also possible to observe that for longer wear (one, two or three days) of wound pads are more easily kept on the wounds(3,8%, - 9,1%, - 17,5%). However, despite this, they could easily be removed from the wound. Even when the duration of socks in three days at 82.5% of cases of kleivane� with injury were observed.

These results allow to conclude that the wound pad is not glued to the wound even after wearing them for three days.

The humidity of the wound pads

In 54 of the 63 cases (85.7 percent) during the replacement of wound wound pads cushion was optimally moist. In 6 cases (9.5%) of the wound pad although it was quite wet, but observers could expect more. Three times (4,8%) observers perceive the humidity as already suboptimal, but noticeably dry wound pads was not seen even once.

Signs of infection

7 of 63 RAS (11,1%), which to this point-in-time data was available had evidence of wound infections at the time of final conclusion.

The ability to fit

Under the ability-to-fit refers to the ability of wound pads to fit the bottom of the wound; thus, in particular, should be prevented the rise of wound pads. The ability to fit used wound pads first observation on the application was 14 times very good (21,2%), 44 times good (66,7%), 7 times satisfactory (10,1%), 1 time is enough (1.5%), and never unsatisfactory.

The condition of the wound compared with the beginning of the research

From 62 patients it was concluded that the wound compared with the beginning of the research. Thus obtained was the following picture

StatusNumberProportion (%)
Markedly improved1524,2
Improved3454,8
Unchanged711,3
Worsened11,6
Noticeably deteriorated58,1

The overall impression

In observations on the application of the General impression of wound pads was estimated at 87.3% of all cases as "very good" or "good". This positive impression was confirmed also by the fact that the expectations are pinned on the new product, in 87.5% of cases were "outclassed", "satisfied" or "mostly satisfied".

1. The wound pad (2) for the treatment of wounds in a moist or wet wet environments containing position suction and flushing the body (4) on the basis of fibrous nonwoven material, which is distributed superabsorbent material, and position suction and flushing the body (4) in the process of making impregnated with salt-containing water �Astrom, in particular, ringer's solution, preferably to saturation, and forming the outer visible side of the wound overlay shell (6), characterized in that superabsorbent material is anionic and comprises negatively charged groups, wherein the aqueous solution contains a substance antimicrobial action, formed by cations of silver, or derivatives, biguanides biguanides, polyguanidine, N-octyl-1-[10-(4-actionoverride-1-yl)decyl]pyridin-4-Eminem (octenidine), Quaternary compounds, triazine or connection of ammonium taurolidine, moreover, the antimicrobial substance is cationic at pH values from 4 to 7.5 typical wet or wet to wet wound environment, and therefore is attracted to the negative anionic groups of the superabsorbent material, and thus acts antimicrobial inner position suction-rinsing body (4), the sheath (6) facing the wound outer side provided with an outer partial structured coatings (16) non-traumatic action with coverage of not more than 70%, and partially structured coating (16) non-traumatic action is a silicone coating.

2. Wound pad according to claim 1, characterized in that the cationic substance antimicrobial action ol�dstanley polyhexamethyleneguanidine and its derivatives.

3. Wound pad according to claim 1 or 2, characterized in that the concentration of cationic substances antimicrobial action in aqueous solution is from 0.06 to 0.20 mass. %, preferably from 0.08 to 0.15 mass. %, more preferably from 0.10 to 0.15 wt. %.

4. Wound pad according to claim 1 or 2, characterized in that the test zone of inhibition (growth of microbes in a dense environment) output cationic substances antimicrobial action of the wound overlay visual is not set.

5. Wound pad according to claim 1 or 2, characterized in that the shell (6) facing away from the wound side contains non-woven material (12) coated on the outer side of the film layer (14), which forms prevent the evaporation film layer.

6. Wound pad according to claim 5, characterized in that the nonwoven material is a polyolefin non-woven material, in particular polypropylene non-woven material.

7. Wound pad according to claim 1 or 2, characterized in that the shell (6) facing the wound-facing and/or facing away from the wound side of the wound lining formed of a textile flat material, in particular a knitted fabric, a knitted fabric or cloth, in particular of polyolefin, in particular polypropylene.

8. Wound pad according to claim 1 or 2, characterized in that the degree of coverage and partially structured nanesena�of coating (16) non-traumatic action is from 40 to 70%, preferably from 40 to 60%, more preferably from 40 to 55%, more preferably from 40 to 50%.

9. Wound pad according to claim 1 or 2, characterized in that the partially structured coating (16) non-traumatic actions has size at least in one direction of the plane not more than 4 mm, preferably not more than 3 mm, and further preferably from 1 to 3 mm, more preferably from 2 to 3 mm.

10. Wound pad according to claim 1 or 2, characterized in that the distance between adjacent areas of the coated surface is at least 1 mm and not more than 5 mm.

11. Wound pad according to claim 1 or 2, characterized in that the position suction and flushing the body (4) on the basis of fibrous nonwoven material comprises cellulose fibers, in particular a mixture of cellulosic fibers and thermoplastic fibers, in particular polyolefin fibers, in particular fibers of polypropylene or polypropylene/polyethylene fibers.

12. Wound pad according to claim 1 or 2, characterized in that the specific area of the evaporation rate in the time interval from 24 to 72 hours after simulated wound overlay overlay is less than 0,020 g/24 h·cm2preferably less than 0,017 g/24 h·cm2, more preferably less than 0.015 g/24 h·cm2, more preferably less than 0.012 g/24 h·cm2.

13. Wound pad according to claim 1 �2 characterized in that the specific evaporation rate of a unit area within the first 24 hours after simulated wound overlay overlay is less than 0.050 g/24 h·cm2fluid, preferably less 0,037 g/24 h·cm2fluid, more preferably less than 0.025 g/24 h·cm2fluid.

14. Wound pad according to claim 1 or 2, characterized in that it has a size in at least one direction in the plane from 2 to 30 cm, preferably from 3 to 20 cm, more preferably from 3 to 15 cm.



 

Same patents:

Antimicrobial gels // 2535013

FIELD: medicine, pharmaceutics.

SUBSTANCE: present invention refers to medicine, particularly to aspects covering antimicrobial compositions, and described antimicrobial compositions, antimicrobial silicone gel based on the above antimicrobial composition, a wound dressing and methods for preparing them. Among other things, the antimicrobial compositions contain at least one alkenyl- and/or alkynyl-substituted polysiloxane, at least one polysiloxane containing silicone-linked hydrogen atoms, and at least one hydroxylation catalyst, at least one hydrophilic ingredient, at least one silver salt.

EFFECT: invention can be used for preparing a drug preparation to be used in treating burns, scars, bacterial infections, viral infections and/or mycotic infections.

19 cl, 5 dwg, 8 ex, 6 tbl

FIELD: medicine.

SUBSTANCE: invention refers to medicine, particularly to aspects including dressing materials, and describes a multilayer wound dressing possessing a favourable combination of pH value and absorption ability, comprising the first layer as a wound-contacting layer which integrates an aqueous hydrogel matrix, and at least the second absorption layer. The hydrogel matrix contains 37-43 wt % of propylene glycol, pre-polymer with terminal groups of isophorone diisocyanate and diamine of polyethylene oxide in an amount of 12-16.5 wt % in all, 0-5 wt % of inorganic chloride, as well as residual water, with a ratio of reactive groups of isocyanate to amino groups of diamine being expected to make 1.25-1.35.

EFFECT: invention can be used for damp wound healing, particularly for granulating and epithelising wound healing.

17 cl, 3 dwg, 8 ex, 5 tbl

FIELD: medicine.

SUBSTANCE: invention refers to medicine, particularly to aspects including dressing materials, and describes a multilayer wound dressing possessing a favourable combination of pH value and absorption ability, comprising the first layer as an absorption layer which integrates an aqueous hydrogel matrix, and at least the second layer covering the first layer on the side facing from the wound. The hydrogel matrix contains 54-60 wt % of propylene glycol, pre-polymer with terminal groups of isophorone diisocyanate and diamine of polyethylene oxide in an amount of 38-42 wt % in all, 0-5 wt % of inorganic chloride, as well as residual water, with a ratio of reactive groups of isocyanate to amino groups of diamine being expected to make 1.25-1.35.

EFFECT: invention can be used for damp wound healing, particularly for granulating and epithelising wound healing.

10 cl, 1 dwg, 5 ex, 2 tbl

Wound bandage // 2519683

FIELD: medicine.

SUBSTANCE: invention relates to medicine, in particular to a multi-layered wound bandage for treatment of wounds in granulation and epithelisation phases. Described is the wound bandage, which contains a) the first layer as a layer of contact with the wound, which has the first side and the second side, and b) at least, one second layer as an absorbing layer with the first side and the second side, containing hydrophilic polyurethane foam, with polyurethane foam having a water content equal to, at least, 10 wt %.

EFFECT: wound bandage transmits low displacing effort to the processed wound.

7 cl, 3 dwg, 1 ex

FIELD: chemistry.

SUBSTANCE: claimed invention relates to obtaining superabsorbing polymer particles. Described are versions of producing superabsorbing polymer composition with recycled superabsorbing polymer finely crushed particles, including the following stages: a) processing superabsorbing polymer finely crushed particles, which have the average particle size less than about 150 mcm with caustic solution, containing from about 0.1 to about 12% of caustic relative to the mass of superabsorbing polymer finely crushed particles, where caustic is selected from sodium hydroxide, sodium carbonate or sodium bicarbonate; b) mixing processed superabsorbing polymer finely crushed particles, obtained at stage a), with polymerisation solution, containing at least one cross-linking agent and partially neutralised monomer, where said monomer solution includes initiator, in which content of superabsorbing polymer finely crushed particles relative to the total amount of monomer constitutes from about 0.1 to about 30 wt %; c) polymerisation of mixture, obtained at stage b), with obtaining superabsorbing polymer gel, and where said polymer represents cross-linked polymer from polyacrylic acid, sodium polyacrylate or their copolymers; d) crushing superabsorbing polymer gel, obtained at stage c); e) drying said crushed polymer gel; f) separation of said dried gel, obtained at stage e) into part, which has desirable size of particles from about 150 mcm to about 850 mcm, thus forming superabsorbing polymer particles; g) coating said particles of superabsorbing polymer, obtained at stage f), with surface cross-linking agent and surface additives; h) heating said coated polymer; and i) separation of said dried superabsorbing polymer particles, obtained at stage h) into part, which has desirable size of particles from about 150 mcm to about 850 mcm, thus forming target superabsorbing polymer composition. Described is superabsorbing polymer composition, possessing superabsorbent properties, obtained by the method, described above. Described is method of recycling superabsorbing polymer finely crushed particles in production of superabsorbing polymer composition, which includes the following stages: a) processing superabsorbing polymer finely crushed particles, which have the average particle size less than about 150 mcm with caustic solution, containing from about 0.1 to about 12% of caustic relative to the mass of superabsorbing polymer finely crushed particles, with caustic being selected from sodium hydroxide, sodium carbonate or sodium bicarbonate; b) mixing processed superabsorbing polymer finely crushed particles, obtained at stage a), with polymerisation solution, containing at least one cross-linking agent and partially neutralised monomer, in which content of superabsorbing polymer finely crushed particles relative to the total amount of monomer constitutes from about 0.1 to about 30 wt %, with said monomer solution including initiator; c) polymerisation of mixture, obtained at stage b), with obtaining superabsorbing polymer gel, with said polymer representing cross-linked polymer from polyacrylic acid, sodium polyacrylate or their copolymers; d) crushing superabsorbing polymer gel, obtained at stage c); e) drying said crushed polymer gel; f) separation of said dried gel, obtained at stage e) into part, which has desirable size of particles from about 150 mcm to about 850 mcm, thus forming superabsorbing polymer particles; g) coating said particles of superabsorbing polymer, obtained at stage f), with surface cross-linking agent and surface additives; h) heating said coated polymer; and i) separation of said dried superabsorbing polymer particles, obtained at stage h) into part, which has desirable size of particles from about 150 mcm to about 850 mcm, thus forming target superabsorbing polymer composition.

EFFECT: obtaining composition of superabsorbing polymer particles, obtained by method, including recycling of superabsorbing polymer finely crushed particles, with composition possessing improved absorbing ability and improved gel layer permeability.

13 cl, 4 dwg, 4 tbl, 10 ex

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to medicine. What is described is a superabsorbent polymer composite containing superabsorbent polymers and cellulose nanofibrils having a diameter of 100 nm or less. The composite may be presented in the form of either particles, or foam. There are also described methods for preparing the composite and absorbent products containing the superabsorbent polymer composite.

EFFECT: cellulose nanofibrils improve the gel strength of the superabsorbent polymer.

23 cl, 6 dwg, 6 ex

FIELD: medicine.

SUBSTANCE: invention refers to medicine, more specifically to absorbent products containing absorbent compositions exhibiting the swelling, deswelling and re-swelling properties. The absorbent compositions swell up and absorb liquids after the effect of water liquids, deswell and release the liquids from the swelled absorbent compositions, and can re-swell and absorb the liquids.

EFFECT: swelling/deswelling/re-swelling properties provide the improved liquid distribution in the absorbent compositions and absorbent products.

15 cl, 21 tbl, 28 dwg, 59 ex

FIELD: medicine.

SUBSTANCE: invention refers to medicine, more specifically to absorbent products containing absorbent compositions exhibiting the swelling, deswelling and re-swelling properties. The absorbent compositions swell up and absorb liquids after the effect of water-containing liquids, deswell and release the liquids from the swelled absorbent compositions, and can re-swell and absorb the liquids.

EFFECT: swelling/deswelling/re-swelling properties provide the improved liquid distribution in the absorbent compositions and absorbent products.

14 cl, 17 tbl, 28 dwg, 59 ex

FIELD: process engineering.

SUBSTANCE: invention relates to super absorbents. Material represents fibers, or film, or foamed material. It contains plasticiser and charged cross-linked clayey gel A. Note here that said gel includes clayey nanoparticles C cross-linked by charged polymer, polyacrylate or polyacrylsulfonate. In said material, any particular clayey nanoparticles is bonded with, at least, one other particular clayey nanoparticles via said charged polymer. Invention covers method of producing said material in the form of fibers, film and foamed material.

EFFECT: production of cross-linked clayey gels including charged polymers.

21 cl, 5 dwg, 3 tbl

FIELD: medicine.

SUBSTANCE: present invention refers to medicine, more specifically to a gel composition for a medical material or a hygienic material which contains a liquid rubber ingredient having a functional group able to create cross linkages, in a molecule, and 90 weight parts or more and 1250 weight parts or less of an organic liquid ingredient in relation to 100 weight parts of the rubber ingredient with the gel composition being cross-linked.

EFFECT: composition for the medical material or the hygienic material contains a great amount of the organic liquid ingredient, has sufficient elasticity and can hold its shape.

7 cl, 4 tbl

FIELD: medicine.

SUBSTANCE: invention relates to medicine. Cooling products and methods of their manufacturing are described. The cooling product consists of a substrate, soaked with a polymer gel and an antimicrobial agent. The product can represent a compression wrap, a laid-on pad, a body wrap, a container wrap, a blanket or an item of clothing.

EFFECT: cooling product does not subject the user to the impact of potentially extreme temperatures, preserves its integrity in the course of time and is reusable.

32 cl, 17 dwg

FIELD: medicine.

SUBSTANCE: group of inventions refers to medicine. What is described is a haemostatic device comprising a carrier material, a surface of which is coated with a printed pharmaceutical composition containing thrombin. What is described is a method for making the haemostatic device comprising the carrier material, the surface of which is coated with the printed pharmaceutical composition. What is described is using the haemostatic device for fastening haemostasis and/or wound healing. The invention also refers to a kit comprising the carrier coated with the pharmaceutical composition and a container with a detachable lid.

EFFECT: printing method enables distributing the composition more accurately on the surface of the carrier material.

32 cl, 7 dwg, 5 tbl, 5 ex

FIELD: medicine.

SUBSTANCE: invention refers to medicine, particularly to a method for active substance (AS) delivery through an epidermal barrier. The declared method involves using a matrix-type transdermal patch containing a substrate, a protective tape and a polymer layer, and characterised by the fact that 10% PEG-12 dimethicone niosomes are introduced into the polymer layer of the transdermal patch; then the substrate is coated with the polymer layer. The ACs are encapsulated into the niosomes with the use of hemogeniser APV, as well as 10 wt % propylene glycol and 5 wt % isopropyl myristate.

EFFECT: improving the active substance penetration with maintaining the biological activity and prolonging the active substance action.

2 tbl, 3 ex

FIELD: medicine.

SUBSTANCE: invention refers to medicine. What is described is a method for producing a therapeutic tissue involving producing a polymer base containing alginic acid salt, administering an active substance in a therapeutically effective amount, agitating the mixture in a slow-speed mixer, applying the prepared composition on a textile material containing at least 50% cellulose fibres, while the composition of the polymer with the active substance is applied on the textile material through a mesh template at a cell size of 200 to 450 mcm to generate a continuous polymer layer on the face surface of the textile material not penetrating to the inner side.

EFFECT: method enables extending the range of therapeutic agents and biologically active additives, enabling variation of their concentration that causes their concentration in treating various diseases, enables fast transformation of the technological process and its cost-effectiveness.

28 cl, 23 ex

FIELD: medicine.

SUBSTANCE: invention refers to medicine, more specifically to a biodegradable absorbent polymer produced from a composition with nitrogen-containing heterocyclic monomer, polymerized acryl or methacryl, a non-organic excipients and an allyl compound of cellulose.

EFFECT: biodegradable absorbent polymer has excellent biodegradability and high absorbing capacity.

11 cl, 3 tbl, 2 dwg, 5 ex

FIELD: medicine.

SUBSTANCE: what is described is a non-woven fabric consisting of several layers and comprises spot-glued carrier with polyamide nanofibres containing at least one antimicrobial substance, and a protecting coat. The polyamide nanofibres are made of polyamide and can be fixed on the carrier by means of a liquid adhesive. Non-woven fibre fabrics of the density of 15 to 90 g/m2 are used as the carrier of the nanofibres and protecting coat: polypropylene, polyester, cellulose-polyester, cellulose or paper. The polyamine nanofibres contain at least one antimicrobial substance in an amount of 0.4 to 35% of nanofibre weight among: guanidines, metal nanoparticles, stabilised silver salts, quaternary ammonium compound salts.

EFFECT: material possesses antimicrobial activity, high air permeability, and fracture resistance.

9 cl, 2 dwg, 5 ex

FIELD: medicine.

SUBSTANCE: invention relates to medicine. Described is method of treating infection of human or animal body surface, in particular, contamination with fungi, including application of water liquid on infected body surface, for instance, nail area, with further application of bandage, which includes hydrogen peroxide source. Combinations of bandage liquid for application in method are also provided.

EFFECT: combination makes it possible to considerably reduce or eliminate infection in nail area.

16 cl, 1 tbl, 2 dwg, 2 ex

FIELD: medicine.

SUBSTANCE: what is described is hydrogel composition containing sodium acrylate, a linking agent, biologically active substances, polyvinyl pyrrolidone, glycerol, propanediol, water, a catalyst agent and a radical polymerisation indicator in the following proportions, wt %: sodium acrylate 2.0-10.0, catalyst agent 0.045-0.48, linking agent 0.195-0.21, radical polymerisation indicator 0.045-0.06, glycerol 4.5-7.5, propanediol 3.0-10.5, biologically active substances 0-1.5, polyvinyl pyrrolidone 0.3-1.5, water - the rest. What is described is a surgical dressing containing a carrier with the hydrogel composition applied thereon.

EFFECT: higher efficacy of the hydrogel composition and surgical dressing thereof, lower labour intensity of the method for preparing the above composition.

10 cl, 1 tbl, 2 ex

FIELD: medicine.

SUBSTANCE: dressing represents a knitted mesh fabric coated with a composition of a biocompatible film-forming polymer of polyvinyl pyrrylidone and drug preparations: iodine, novociane, carboxymethyl cellulose sodium salt, of the following formulation (mg/cm2): iodine 0.0282±20%; polyvinyl pyrrylidone (Mr 20000) 1.2±20%; novociane 0.426±20%; carboxymethyl cellulose sodium salt 1.6-1.9.

EFFECT: using the wipe provides antimicrobial, antiseptic, disinfecting, antifungal and antiprotozoal action ensured by the fact that a polyvinyl pyrrylidone matrix retains iodine in the wipe and promotes its release on the skin.

FIELD: medicine.

SUBSTANCE: postoperative period involves tamponage with Coletex-AGGDM wet tissue within middle nasal passages. The tamponage area is exposed to laser light in the infrared band at a wave length 0.95 mcm at the output power of 2-3 mWt for 4-5 min. After the exposure, the tissue is left for one day. The following procedures are performed with the tissues placed in the middle nasal passage within a natural fistula and on a mucous membrane of a hard palate in a projection of a maxillary sinus bottom. The tamponage area and skin in the projection of the maxillary sinus within an anterior sinus wall are exposed. 2-3 procedures are performed at the output power of 5-7 mWt for 7-10 min for one field. 4-6 procedures are performed at the power of 15-20 mWt for 3-10 min for each field. After the exposure is terminated after each procedure, the endonasal tissue is left for 6-8 hours.

EFFECT: method enables providing higher clinical effectiveness by antibacterial, antiseptic, anti-oedematous effects, recovering the ciliary transport function without injuring the ciliated epithelium; eliminating the postoperative complications, such as sinus bleeding and cicatrical deformity of the mucous membrane.

2 ex

FIELD: medicine.

SUBSTANCE: invention relates to medicine. Cooling products and methods of their manufacturing are described. The cooling product consists of a substrate, soaked with a polymer gel and an antimicrobial agent. The product can represent a compression wrap, a laid-on pad, a body wrap, a container wrap, a blanket or an item of clothing.

EFFECT: cooling product does not subject the user to the impact of potentially extreme temperatures, preserves its integrity in the course of time and is reusable.

32 cl, 17 dwg

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