RU2770402C1 - Composition for postoperative prevention of purulent complications of bone and soft-tissue structures when using external fixation pin-and-frame apparatus, device for postoperative wound sanitation - Google Patents

Abstract

FIELD: medicine.SUBSTANCE: group of inventions refers to medicine, namely traumatology and orthopaedics, and can be used for postoperative prevention of purulent complications of bone and soft-tissue structures when using external fixation pin-and-frame devices. That is ensured by a composition containing the following components: rifampicin - 150 mg, dexamethasone - 4 mg, 1 % dioxidine - 2.5 ml, 95 % ethanol - 15 ml, physiological saline - up to 100 ml. Group of inventions also relates to a device for postoperative wound sanitation, comprising a system for supplying a composition to a wound surface, comprising a collector, a composition dispensing element, applicators and capillary tubes, wherein the applicators are made in the form of a hollow flat structure from a flexible plastic material or in the form of a clip with tabs and have capillary holes on one of the sides.EFFECT: higher efficiency of open wound healing, reduced intoxication, reduced secondary infection, improved results of treatment and reduced risk of inflammatory complications.7 cl, 8 dwg, 2 ex

Description

SUBSTANCE: group of inventions relates to medicine and veterinary medicine, namely to traumatology and orthopedics, and is intended for the prevention and treatment of pyoinflammatory processes in bone and soft tissue structures of the musculoskeletal system using external fixation devices.

In the treatment of open fractures complicated by wound infection, an important task remains to eliminate the occurrence of purulent-inflammatory processes, the occurrence of secondary infection, prevent the occurrence of endogenous intoxication and the development of local purulent-inflammatory complications, pin osteomyelitis, improve treatment results and reduce the length of stay of patients in the hospital.

Known methods of treatment of purulent wounds by washing them with solutions of various antiseptics (US Pat. RF 2068263), antibiotics (US Pat. RF 2008917). A known method for the treatment of purulent wounds by surgical treatment and subsequent dressing with drugs (US Pat. RF 2185781). A common disadvantage of all these methods and means used is the low efficiency of postoperative prevention of purulent complications and the treatment of extensive purulent diseases of soft tissues, including those arising from the use of wire-rod external fixation devices.

A known Method for the surgical treatment of purulent-inflammatory processes of bone and soft tissue structures of the musculoskeletal system of a patient using soft spacers impregnated with antibacterial agents (US Pat. of pathologically altered bone and soft tissue structures, the volume of the bone cavity of the post-resection defect is filled with a spacer in the form of a macroporous cryogel based on polyvinyl alcohol impregnated with antibacterial agents in the form of aqueous solutions of tobramycin and/or dalbavancin with a concentration of 10-50 mg/ml. The installed spacer is removed from the volume of the bone cavity after 40-60 days. The disadvantages are the need for additional surgical intervention to remove the installed spacers, the likelihood of recurrence of purulent-inflammatory processes, complexity and high cost.

In a known method for the prevention of purulent-inflammatory complications in the treatment of traumatological and orthopedic patients using external fixation devices (see Kuranov A.A., Sorokin A.V., Ignatov E.Yu., Ershov V.V. and Kiselev M.N. "Wound dressing from elastic polyurethane of the second generation" Bulletin of new medical technologies, 2012, No. 1) after the spokes, a polyurethane foam composition is used. Oval applicators with a diameter of 1.5-2.0 cm and a thickness of 0.4-0.6 cm are formed from polyurethane foam gel around the needles, which firmly adhere to the needles or rods, as well as to skimmed skin. The created bandage is left for 3-4 weeks. The disadvantage is the lack of reliable control over the microclimate of the wound and the risk of bacterial contamination, which reduces the effectiveness of the treatment and prevention of pyoinflammatory complications.

A known Method for the treatment of bite wounds (US Pat. 2597767, RU, IPC A61K 33/38, A61K 31/4025, A61K 31/41, 2015), to which an emulsion containing: lidocaine hydrochloride 0.25-0 is used as a therapeutic and prophylactic external agent .5%, thrombolysin 25-29%, metronidazole 0.2-0.24%, clindamycin 0.25-0.29%, rifampicin 0.35-0.4%, olive oil 5.0-9.0% , sea buckthorn oil 1.0-1.4%, starch 4.5-5.0% and silver water 50.57-63.45% with a concentration of silver ions in it 30-36 mg / l. A napkin with an emulsion is changed daily until the pronounced hyperemia and swelling of the tissues around the wounds disappear. The disadvantage of the known means is the insufficient range of suppressed varieties of pathogenic organisms.

Known Device for the treatment of contaminated wounds (US Pat. 2493886, RU, IPC A61M 35/00, 2010), designed to wash the wound under controlled pressure. In the device, a multi-chamber container with medicines is installed on a tripod, connected to an air injection device. The device provides a system for supplying medicines to the wound surface. To do this, each chamber is connected by tubes to a collector, from which liquid is supplied through a hose into a rigid cup applied to the wound. The possibility of outflow of liquid from a rigid cup is provided. It is advisable to use the known device for supplying large volumes of fluids to the wound, but it is not designed for use in the treatment of traumatological and orthopedic patients using external fixation devices, including transosseous osteosynthesis of long tubular bones, the introduction of pins and intraosseous rods into their proximal and distal fragments by compression - a distraction apparatus for external fixation, followed by application of an antimicrobial drug to the defatted surface of the patient's skin at the entry and exit points of the pins and intraosseous rods and to the contact zones of the patient's skin with the pins and intraosseous rods.

The task of the group of inventions is to create a new composition and a new device that increase the effectiveness of the treatment of open and sutured musculocutaneous wounds in open fractures and internal osteosynthesis.

The technical result of solving the task is to increase the efficiency of healing open wounds, reduce intoxication, reduce the attachment of a secondary infection, improve treatment results, and reduce the risk of inflammatory complications.

To solve the problem and achieve the specified technical result, a group of inventions, united by a common inventive concept, is proposed. One aspect of the proposed group of inventions is a composition characterized in that it contains rifampicin, dexamethasone, dioxidine 1%, ethyl alcohol 95%, with the following in the following ratio, wt. %:

Rifampicin - 150 Dexamethasone - 4 Dioxidine, 1% - 2.5 Ethyl alcohol, 95% - fifteen Saline - rest

The claimed combination of components and their quantitative ratio made it possible to achieve synergy and obtain a prophylactic composition with antibacterial, anti-inflammatory, antimicrobial and therapeutic properties. The above set of features of the proposed composition (composition and quantitative ratios of components) was not previously known, which indicates the novelty of the proposed solution. The set of essential features of the claimed composition does not follow explicitly from the studied prior art, i.e., has an inventive step.

The claimed composition was obtained by the author experimentally. As experimental studies and clinical practice have shown, the claimed composition for external use in the postoperative period for the treatment of trauma and orthopedic patients using various external fixation devices has a pronounced antimicrobial effect against pathogens of infectious complications of wounds, anti-inflammatory and wound healing effects. It provides aseptic conditions for healing, protects the wound from contamination and infection, and is applicable for the prevention of purulent complications and postoperative osteomyelitis. The proposed composition is easy to manufacture without significant material costs by simply mixing finished drugs. Mix 150 mg of rifampicin, 4 mg of dexamethasone, 2.5 ml of dioxidine 1%, 15 ml of ethyl alcohol 95% and bring to 100 ml with saline. The freshly prepared composition is an odorless liquid without sediment, light orange in color, which can be used, among other things, in traditional methods of treating purulent wounds. The use of the proposed composition will reduce the duration of treatment by eliminating complications in the form of secondary infections, and ensure the reliability of the results at a qualitatively new level.

Characteristics of the components of the composition.

Rifampicin is an anti-tuberculosis drug. Semi-synthetic broad-spectrum antibiotic. In low concentrations, it has a bactericidal effect on Mycobacterium tuberculosis, Brucella spp., Chlamydia trachomatis, Legionella pneumophila, Rickettsia typhi, Mycobacterium leprae. Effective against intracellular and extracellular microorganisms. Suppresses DNA-dependent RNA polymerase of microorganisms. Rifampicin acts on gram-positive (especially staphylococci), including multi-resistant, streptococci, gram-positive spore rods (the causative agent of anthrax and clostridia). It also has an effect on gram-negative (meningococci, gonococci) cocci.

Dexamethasone is a medical and veterinary drug, a synthetic glucocorticosteroid, has anti-inflammatory and immunosuppressive effects, has been used in the treatment of autoimmune diseases since the 1960s, and is currently used in the treatment of many diseases and conditions. Dexamethasone has a pronounced anti-inflammatory, anti-allergic, desensitizing and immunosuppressive effect. In terms of activity, dexamethasone exceeds other glucocorticosteroids: the drug is 7 times more active than prednisolone and 35 times more active than cortisone [Mashkovsky M.D. Medicines: in 2 volumes. T. 2. M .: New Wave Publishing LLC, 2003. - 608 p.].

Dioxidin is a broad-spectrum antibacterial drug from the group of quinoxaline derivatives, has chemotherapeutic activity in infections caused by Proteus vulgaris, dysentery bacillus, Klebsiella, Pseudomonas aeruginosa, salmonella, staphylococci, streptococci, pathogenic anaerobes (including pathogens of gas gangrene), acts strains of bacteria resistant to other chemotherapy drugs, including antibiotics. Dioxidine, like other derivatives of di-N-hydroxyquinoline, is characterized by high chemotherapeutic activity in purulent bacterial infections. Dioxidine is a broad-spectrum antibacterial drug. It acts on strains of bacteria that are resistant to other chemotherapy drugs, including antibiotics.

Ethyl alcohol 95% - antiseptic. When applied externally, it has an antimicrobial effect. Active against gram-positive and gram-negative bacteria and viruses. Denatures the proteins of microorganisms. It is an osmotically active substance that absorbs purulent exudate by binding water molecules to hydroxyl and ether groups. It is used for the manufacture of dosage forms for external use, tinctures, extracts. Compound:

active ingredient: ethanol - 95%; excipient: purified water - 5%.

Saline solution - sodium chloride solutions are widely used in medical practice and, depending on the concentration, are divided into isotonic (0.9%) and hypertonic. Hypertonic solutions (3-5-10%) are applied intravenously and externally. When applied externally, they contribute to the release of pus, exhibit antimicrobial activity.

Another aspect of the proposed group of inventions is a device for debridement of a postoperative wound, containing a system for bringing the composition to the wound surface, including a collector. The device is supplemented with a dosing element, for example, a syringe, applicators connected to the collector by capillary tubes, the ends of which are integral with the transition cannulas. The collector is provided with a branch pipe for connection with a syringe, and on the opposite side of the collector there are conical branch pipes mating with the cannulas of the capillary tubes. A fastening element is made on the manifold for installation on the external fixation apparatus. The applicator, made in the form of a hollow flat structure made of a flexible plastic material, has capillary holes on one side, and is equipped with a branch pipe that mates with the cannulas. In this case, the collector may contain 2÷15 conical nozzles and has a rectangular or radius shape in plan. In addition, the applicator used in the exit area of the spokes and rods is made in the form of a bracket with tabs, and the inner diameter of the bracket is equal to the diameter of the spokes or rods. The applicator intended for applying the composition to the wound surface may have a rectangular, square, triangular shape.

Differences of the claimed device from the prototype are that:

- the addition of the device with a dosing element, applicators and capillary tubes connected to the collector, the ends of which are integral with the transition cannulas, ensures controlled and dosed delivery of the drug to the wound, which eliminates the need for frequent dressings of wounds, as well as manual processing of rods and skin areas in points of entry/exit of spokes and rods, alleviates the patient's condition, eliminates the risk of secondary infection in the postoperative period;

- the possibility of placing the device on the external fixation device in the form of a bracket contributes to the convenience in work and the effectiveness of treatment;

- making the applicator flexible and flat and with holes on one side makes it possible to supply liquid to a hygroscopic material that is in direct contact with the skin in the area where the pins and rods exit, or with the wound surface, and ensures sterility and suppression of the development of bacterial microflora, i.e. , reduction of intoxication, reduction of secondary infection.

These distinctive features allow us to conclude that there is novelty in the proposed technical solution. The patent studies conducted by the author related to the designs of devices for treating wounds after transosseous osteosynthesis by the method of external fixation did not find solutions that have features similar to the claimed invention, which allows us to conclude that the inventive step criterion is met. Industrial applicability is confirmed by the possibility of manufacturing the device on standard equipment and clinical practice.

The invention is illustrated by the description and illustrative material,

where:

Fig. 1 - general view of the device;

Fig. 2 - section of the collector along A-A;

Fig. 3 - collector;

Fig. 4 - applicator in the area of the exit of the spokes and rods;

Fig. 5 - applicator for use on the wound surface;

Fig.6 - section of the applicator B-B;

Fig. 7 - diagram of the assembly of the device under conditions of osteosynthesis with an external fixation device;

Fig. 8 - diagram of the assembly of the device when performing submersible osteosynthesis using a bone plate;

The device for debridement of a postoperative wound consists (Fig. 1) of a collector 1, capillary tubes 2, made integral with transitional cannulas 3, applicators 4, a dosing element in the form of a syringe 5. The collector 1 (Fig. 2, 3) is a closed container, made of polymeric materials. The collector 1 has a branch pipe 6 for connection with a syringe 5, which supplies the composition to the collector, and on the opposite side of the collector 1, conical pipes 7 are made, mating with transitional cannulas 3 of the capillary tubes 2, which transfer the prophylactic composition to the applicator 4. Cannulas 3 installed at the ends of the capillary tubes 2 are identical to each other, which provides this node with versatility. Branch pipes 7, temporarily not involved in the distribution and delivery of the composition to the wound surface, are closed with plugs 8. The collector 1 may contain 2÷15 distributing conical pipes 7 and may have a rectangular or radius shape in plan (top view), which allows the manufacture of a set of collectors, and improves the usability of the device. To install the collector 1 on the external fixation device, a fastening element is provided, for example, a bracket 9.

The applicator is designed to bring the medicinal mixture to the wound. It is a hollow flat structure made of a flexible plastic material (for example, polyethylene, polypropylene or polyurethane), into the internal cavity of which a therapeutic agent is introduced to prevent a wound. Capillary holes 10 are made on one of the surfaces of the applicator. For supplying the drug composition, the applicator is equipped with a branch pipe 11 that mates with cannulas 3. The applicators differ in their external shape. To use the applicator in the exit area of the spokes and rods, an applicator in the form of a bracket (Fig. 4) with paws 12 is proposed. allow you to compress the bracket and provide additional fixation on the spoke. The applicator (Fig. 5), designed to supply the inventive composition to the wound surface, may have a rectangular, square, and other acceptable shape. The applicators are applied to a hygroscopic dressing that is in direct contact with the skin or with the wound surface.

Preparation for work. Syringe 5 (or dosing element) is filled with the claimed composition and installed on nozzle 6 on manifold 1. Cannula 3 of capillary tube 2 is installed on nozzle 7, and the opposite one is connected to applicator 4. postoperative wound, using bracket 9, on the external fixation device (Fig. 7). Then, at the points of entry and exit of the pins and intraosseous rods, a hygroscopic dressing is applied to the defatted surface of the patient's skin, on which applicators 4 are placed. By pressing the piston of the syringe 5, the composition is supplied to the device and delivered to the treated wound. The inventive complex is used during the entire period of fracture healing, up to the removal of external fixators (rods and spokes). In the case of an operating wound formed during surgical treatment, the device and the prophylactic antiseptic composition are used similarly. Thus, the creation of unfavorable conditions for the development of microbes is ensured, since the saturation of the surface of the skin with the claimed composition reduces the development of bacterial microflora and reduces the local reaction to rods, knitting needles, and suture material. The dosed supply of solutions to the point of exit of the rods and spokes, as well as open and sutured wounds and the possibility of saturating the hygroscopic material from the state of slightly wet to the state of draining the solution from oversaturation of the absorbent surface, create controlled conditions for wound healing. Sanitation of the infected surface by repeatedly repeated washings with a composition of antibacterial agents and antiseptics in one preparation leads to an increase in the effectiveness of therapy due to postoperative prevention of purulent complications.

A group of inventions for the prevention and treatment of purulent-inflammatory processes in bone and soft tissue structures have shown their effectiveness not only for wire-rod external fixation devices (Example 1), but can be used in accordance with the general concept set forth in the claims, when performing submersible osteosynthesis using a bone plate (Example 2).

Clinical examples.

Example 1. On June 25, 2019, a Staffordshire Terrier dog was delivered to the BION veterinary clinic in Sevastopol. As a result of an accident, the dog received an open comminuted fracture of the right tibia. The operation was performed by the method of open reposition of bone fragments with subsequent fixation of fragments using an arcuate ring external fixation apparatus. In total, during the surgical intervention, 6 threaded transosseous fixators were introduced into different planes of the proximal and distal fragments, while the transosseous rods were fixed on the annular hardware supports. The formed surgical wound, necessary for access to bone fragments, was closed with 9 loop-like sutures at the end of the operation. The wound was drained with synthetic drainage. After the operation, one 8-channel collector and one 4-channel collector were attached to the proximal support of the hardware structure. From the 8-channel collector, 6 capillary tubes were distributed to each of the six inserted transosseous rods.

The capillary tubes were connected to the applicators exposed to the rods through a gauze pad, which is applied to the defatted skin surface at the entry and exit points of the pins. The perforated side of the applicators was pressed against the wound opening. In addition, a narrow gauze cloth was applied to the formed surgical wound, on which 3 rectangular applicators were placed, connected to a 4-channel collector. Unused branch pipes of the collectors were closed with plugs. The pre-prepared inventive composition was fed into both collectors using a 20 ml injection syringe. The degree of saturation of gauze wipes with the composition was determined by the intensity of their moistening. At the same time, the amount of the claimed solution in 5 ml was considered the reference volume for this procedure. And for the prevention of the surgical wound, a reference volume of 10 ml was considered. Submission of the claimed composition in dosages of 5 and 10 ml was carried out 1 time in 48 hours. Only 7 introductions. On the 14th day after the operation, a clinical assessment was made of the area where the rods came out of the skin. It was found that there is no discharge from the area where the rods exit from the skin; when pressing on the area of contact between the skin and the rod, there is also no separation of sanious, liquid or mucous volumes. Redness, soreness, swelling of the contact area is also absent. When examining the surgical wound, it was found that the suture was completely dry, there was slight desquamation around the wound scar, the presence of a dry surface was also noted in the compression hole left after the removal of the stitches, the exit channels of the drainage tube were dry. The stitches were removed painlessly. Redness, swelling, divergence of the edges of the wound are not established. The wound collector has been removed. Further, in the area of contact of the rods with the skin, according to the same prescription, prophylaxis was carried out for 3 weeks. The frequency of treatments was changed, 1 time in 3 days. Only 7 treatments. 21 days after the secondary ligation, it was found that the areas of contact of the rods with the skin were dry, without discharge, painless and not inflamed. In total, in terms of time, the hardware structure after the healing of the fracture was removed after 35 days. During the operation of the hardware design, the density of the touched rods into the bone was optimal. The wound and the area where the rods and wires came out of the skin did not become inflamed during the entire treatment period, the wound healed optimally with the removal of sutures and removal of drainage on the 14th day. The absence of a fracture discharge from the wound channels during the treatment period prevented maceration of the area of insertion of transosseous rods and subsequent suppuration of these areas with signs of contact dermatitis and possible involvement of bone tissue directly in contact with the rods in the process.

Example 2. On January 12, 2020, a German shepherd was admitted to the BION veterinary clinic in Sevastopol with an open transverse fracture of the bones of the right leg. At the same time, the distal end of the tibia, contaminated with clay particles, was exposed. After sanitation of fragments, wounds and surrounding tissues, the bone marrow canal was tunneled in the proximal and distal direction. Next, internal osteosynthesis was performed using a bone plate. After the bone fragments were repositioned and the plate was placed on the bone, 20 holes, 2.5 mm in diameter, were drilled along the plate itself from the side of the surgical wound on both sides perpendicular to the medullary canal. Further, a drain was put into the wound, the wound was sutured with a slight tension of the edges of the wound, a dry bandage was applied over the wound. In the proximal section, on the inner side of the lower leg closer to the knee joint, a hollow threaded rod 55 mm long with a cannula at the end was installed (Fig. 8). The rod was mated with a capillary connected to a 2-channel manifold, where one branch pipe was closed with a plug. The collector was attached to a bandage covering the surgical wound. The cannulated rod was covered with a separate bandage. With the introduction of the claimed composition in a volume of 7 ml with a syringe through a collector, through a capillary and a rod in 20-30 seconds. the impregnation of the gauze napkin covering the surgical wound began, which indicated the presence of a drainage system of the bone canal-operative wound. Also, the composition flowed into the drainage hole. The total volume for postoperative treatment was 15 ml. The introduction of the solution in this dosage was carried out 1 time in 24 hours for 7 days. After that, the condition of the wound was assessed. The wound was macerated with a solution, the sutures were consistent, not edematous, the stability of the plate that holds the bone fragments together after manual loading is obvious. Further, the sanitation of the bone marrow canal and the fracture area was carried out for 21 days with an interval of 1 time in 3 days, a total of 7 procedures, the bandage was not changed. The bandage and sutures were removed on the 40th day. Results: there was no rejection of the bone plate; within 40 days, the formation of high-quality secondary callus was noted. The surgical wound healed without complications, the sutures, despite the long stay on the surgical wound, did not macerate. Slightly accumulated dry discharge. The stitches were safely removed.

Claims (7)

1. Composition for postoperative prevention of purulent complications of bone and soft tissue structures when using wire-rod external fixation devices, consisting of active ingredients, one of which is rifampicin, characterized in that the composition contains dexamethasone, 1% dioxidine as active substances , ethyl alcohol 95%, in the following ratio of components: rifampicin - 150 mg; dexamethasone - 4 mg; 1% dioxidine - 2.5 ml; ethyl alcohol 95% - 15 ml; saline solution - up to 100 ml. 2. A device for debridement of a postoperative wound with a composition according to claim 1 when using wire-rod external fixation devices, containing a system for bringing the composition to the wound surface, including a collector, characterized in that the device is supplemented with a dosing element for the composition, applicators, capillary tubes, the ends of which are made at the same time with transitional cannulas for connection with the collector and applicators, respectively, while the collector is provided with a branch pipe for connection with a syringe, and on the opposite side of the collector there are conical branch pipes mating with the cannulas of the capillary tubes, in addition, the collector is made with the possibility of installation on an external fixation device, and the applicators, made in the form of a hollow flat structure made of a flexible plastic material or in the form of a bracket with paws, have capillary holes on one of the sides and are equipped with a branch pipe that mates with the cannulas. 3. The device according to claim. 2, characterized in that the collector contains 2-15 conical nozzles. 4. The device according to claim. 2, characterized in that the collector has a rectangular or radius shape in plan. 5. The device according to claim 2, characterized in that the applicator used in the exit area of the spokes and rods, made in the form of a bracket with paws, has an inner diameter of the bracket equal to the diameter of the spokes or rods. 6. The device according to claim. 2, characterized in that the applicator, designed to deliver the composition to the wound surface, has a rectangular, square, triangular shape. 7. The device according to claim 2, characterized in that the element dispensing the composition is made in the form of a syringe.

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