RU2171103C1 - Method and remedy for preventing mandibular traumatic osteomyelitis in active mode - Google Patents

Abstract

FIELD: medicine. SUBSTANCE: remedy is produced on the base of cellulose derivative and some antibacterial preparation. 2% aqueous NaK methyl ellulose solution is applied as the cellulose derivative. 0.2% Ciprophloxacin solution and 0.5 % Metronidazol solution additionally containing methyl uracyl and hydroxyapatite is used as the antibacterial preparation. The ingredients are taken in known quantitative proportions. Method involves draining suppurating lesion zone, reducing and fixing fractured bone fragments, treating the oral cavity. Physiologically active film is placed over the fractured bone fragments for 5-7 days to isolate the wound from suppurating zone surrounding it. EFFECT: accelerated treatment course. 2 cl

Description

 The invention relates to medicine, namely to dentistry, and can be used for the active prevention of traumatic osteomyelitis in the complicated course of a fracture of the lower jaw.

 Known dressing that is used to treat purulent wounds - a complex polymer compound (chlorhexidine salt of monocarboxyl cellulose). Compounds based on cellulose and its derivatives with an antibacterial or antiseptic drug have a prolonged antimicrobial effect (up to 1-3 days), as well as adsorption ability, which is 2-25 times higher than that of cotton wool, gauze, carbon materials and many dressings based on natural and artificial polymers. (Abaev Yu.K., Kaputsky V.E., Adarchenko A.A. New dressing for the treatment of purulent wounds. // 3 Healthcare. - N 11. - 1995. - p. 27-30.) Currently used in As sorbents, fibrous cellulosic, carbon and synthetic materials in most cases do not have a high adsorption capacity, which makes it possible to desorb the absorbed components of pus and microorganisms into the wound. In addition, many known wound coatings do not have an antibacterial effect.

 It is now known that suppuration of wounds is often caused not by a single type of microorganism, but by microbial polyassociations containing gram-positive, gram-negative and non-clostridial microflora. Therefore, the effect on the purulent focus should be complex. The purpose of antibiotic treatment should include the type of microorganisms and their sensitivity to the selected antibiotic. In the clinic, the type of microorganism can be determined no earlier than a day after bacteriological culture taken from the wound material. To determine the sensitivity of microflora to antibiotics, another 2-3 days are required. In order to recognize non-clostridial microflora, sowing on special biological media with a certain cultivation mode is required. Thus, from the moment a patient enters the clinic to receive tests for sensitivity to an antibiotic, 3-4 days pass, and before that time, as a rule, a drug is prescribed to which the microflora may be insensitive.

 A known method for the prevention of traumatic osteomyelitis in a fracture of the lower jaw, complicated by an abscess or phlegmon of the maxillary tissue. The following technique is used: drainage of the abscess, reposition and immobilization of fragments, sanitation of the oral cavity and removal of the tooth from the fracture line. A tampon with an antiseptic or antibacterial drug is left in the wound, which is changed during subsequent dressings of the patient. Prescribe antibacterial, anti-inflammatory treatment, immunostimulating therapy. (Lepelin A.V., Shashkov P.V., Galkina T.S. On the pathogenesis and prevention of traumatic osteomyelitis of the lower jaw // Problems of the pathophysiology of injuries and degenerative diseases of the joints. - collection of scientific works under the editorship of D. Pucignan N. . - Saratov. - 1988. - p. 26-29.). Patients with such a complicated course of a fracture of the lower jaw are hospitalized according to CSG from 9 to 13 days.

 The existing method for the prevention of traumatic osteomyelitis has several disadvantages.

 One of the factors in the development of traumatic osteomyelitis is infection of the fracture line surrounding the traumatic focus by purulent discharge. In this case, the threat of osteomyelitis is directly proportional to the duration of the direct exposure of pyogenic microflora to damaged bone tissue. The usual method of prevention does not provide isolation of the fracture gap from constant infection.

 Critical consideration should be given to the administration of antibiotics. The most commonly used intramuscular, intravenous and oral routes. With the first two routes of administration, the drug is delivered to the site with a blood stream, and with the last, it overcomes the tissue barrier, after which it also enters the inflammatory focus. Some of the injected drug is deactivated by digestive and liver enzymes. In addition, given the violation of microcirculation in the focus of inflammation, exacerbated by crushing of injured tissues, the transport of antibiotics to a purulent wound is difficult. Therefore, it is necessary to increase the administered dose to obtain the maximum therapeutic concentration in the purulent focus surrounding the fracture line. Such an increase in the administered dose can lead to a number of undesirable consequences: a violation of the biocenosis of the gastrointestinal tract and, as a result, the development of dysbiosis, impaired liver and kidney function, and the development of allergic reactions.

 The purpose of this invention is to develop a method and means of active prevention of traumatic osteomyelitis and reduce the treatment time for inflammatory complications of fractures of the lower jaw.

 This goal is achieved through the use of a biologically active film (BAP), which has multivalent pharmacological properties.

The film was created in the laboratory. As a base, purified Na-carboxymethyl cellulose (NaKMC) powder was used. The amount of NaCMC was 2% by volume of the film. Such a quantity is considered optimal for the film-forming process (Technology of dosage forms under the editorship of Kondratieva TS - M .: Medicine. - Volume 1. - P. 86.). In our case, the volume of the film was equal to the volume of the cuvette — 10 ml (10,000 mg). Therefore, the desired mass of NaKMTS is 200 mg. This amount of powder was added to 6.5 ml (6500 mg) of distilled water and allowed to swell for 30 min at a temperature of 37 ^o C. After swelling, this solution was mixed until a homogeneous colloidal mass. Then, antibiotic solutions were introduced into this mass in the amount of 5% by weight of NaKMC. Among antibiotics, solutions of ciprofloxacin 0.2% and metronidazole 0.5% were chosen as the most suitable for achieving the goal. Their volume was 2.5 ml (5 mg) and 1 ml (5 mg), respectively. The choice of antimicrobials is based on the suppression of the widest possible spectrum of pathogenic microflora until the results of bacteriological culture are obtained. The spectrum of their action is aerobic gram-positive bacteria, aerobic gram-negative bacteria, anaerobic bacteria (spore-and non-spore-forming), protozoa. In addition, 5 mg of methyluracil substance was included in the film, which amounted to 5% by weight of NaCMC. Methyluracil reduces exudative-alterative changes in the lesion, prevents excess connective tissue from growing into the fracture line, and the formation of scars. To enhance the processes of osteoregeneration, the structure of a biologically active film included 5% by weight of NaKMTs (5 mg) of granular hydroxyapatite, which in this composition plays the role of a sorbent.

After stirring, a homogeneous mass is obtained, which is poured into a standard cuvette and left to dry in a thermostat at a temperature of 37 ^o C for 3 days. During this time, the process of film formation occurs. The resulting film is translucent with a yellowish tint, elastic, easily acquires a gel-like structure in water. After drying, it reverts to film.

 The antibacterial activity of BAP was evaluated by growth retardation of the test culture, comparing with standard disks containing the same amount of the drug. The results obtained in the study group were 1.3 times higher than in the control group. This indicates that NaKMTs and the pH of its solutions do not affect the properties of the studied antibiotics. In the process of film formation, as the solvent is removed, part of the antibiotic is located, as it were, on the surface of the film, part - inside, in the thickness of it. When washing with water, the drug located on the surface of the film is most quickly removed. An antimicrobial drug enclosed in a film thickness is released as it is lysed, providing a gradual, prolonged effect.

 Osteoregenerative activity was studied in an experiment on the model of an open fracture of the lower jaw, complicated by a paramandibular abscess. The experiment was conducted on 48 white laboratory mice weighing 20-24 g, which were divided into 3 groups. The first (control) group included 16 mice with an open fracture of the lower jaw. In the second group (comparisons) - 16 animals in which soft tissues surrounding the fracture line were infected with 0.1 ml of native pus. The third (main) group consisted of the same number of mice (16) with infected maxillary tissues. However, in this group, after opening the purulent focus, the fracture line was isolated from the surrounding primary purulent wound with a biologically active protective film.

 Under ether anesthesia, the animal of all groups with a chisel was injured through the oral cavity in the projection of the middle third of the lower jaw body on the left. Group 2 and 3 mice were then infected with 0.1 ml of native pus introduced into the soft tissues of the submandibular region on the left in the projection of the fracture line. Purulent culture was taken from the patient after opening a suppurative hematoma and was a polyassociation consisting of Staphylococcus aureus, hemolytic streptococcus and Escherichia coli. One day later, under ether anesthesia, the animals of these groups were opened with a purulent wound. After sixteen mice of the 3rd group, a fracture line was exposed after opening a maxillary abscess. Then, a biologically active film was fixed on the fracture line, which hermetically isolated the fracture gap from the surrounding infected tissues.

 Jaw immobilization was not carried out. Animals received food of liquid consistency. The results were monitored on days 7 and 14. The conclusion from the experiment was carried out by an overdose of ether anesthesia. Depending on the time of the end of the experiment, the animals of the first, second, and third groups were divided into two subgroups (a and b). After the conclusion from the experiment, a fragment of the body of the lower jaw with a fracture line and surrounding soft tissues was taken from all animals. The drug was fixed in a 10% formaldehyde solution. Then, bone decalcification field sections were prepared for subsequent microscopic examination.

 The study was carried out with a Biolam-Lomo microscope with magnification on the eyepiece (x7) and on the lens (x8). The preparations were photographed on a Zenit-11 camera at a shutter speed of 1/250 second and magnification on the lens (x20). The following results were obtained.

 In group 1a (8 mice) - bone fragments; single foci of growing into the area of the defect and hematoma of young mesenchymal elements and vessels. In one case, 12.5% (1a2) showed hyperemia; inflammatory edema; focal neutrophilic periosteum infiltration - a histological picture of serous periostitis.

 In group 1b (8 mice) - on all preparations the formation of preliminary connective tissue callus; proliferation of osteoblasts in the area of damage. In two cases - 25% (1b3 and 1b7), foci of purulent inflammation of the bone marrow spaces are determined; bone beams with foci of lacunar resorption - a picture of acute osteomyelitis.

 Group 2A (8 mice). In two animals - 25% (2a1 and 2a2) - weakly expressed foci of consolidation; foci of growing into the region of the defect of young mesenchymal cells. Acute osteomyelitis (accumulation of neutrophils in the bone marrow spaces, foci of lacunar resorption) and purulent periostitis (diffuse purulent infiltration) on all preparations.

 Group 2b (8 mice) on all preparations foci of growing into the area of the defect of mesenchymal cells; phenomena of acute osteomyelitis and acute periostitis. In three animals - 37.5% (2b2, 2b3, 2b5) the formation of sequestration is determined.

 In group 3a (8 mice) on all preparations, preliminary connective tissue callus; proliferation of osteoblasts in the area of damage; single malignant bone beams; growing into the area of a vascular defect. There are no inflammatory changes.

In group 3b (8 mice) - the formation of preliminary callus; foci of mature bone tissue with randomly spaced bone beams. In one case - 12% (3b5), focal purulent periosteum infiltration is determined - periostitis phenomena,
A method for the active prevention of traumatic osteomyelitis was as follows. After reposition and fixation of the fragments by the orthopedic design, the tooth is removed from the fracture line. The hole is treated with an antiseptic solution and sutured. Next, an autopsy of the purulent focus is performed. After evacuation of purulent discharge and antiseptic treatment of the purulent cavity, non-viable fragments of bone tissue are removed. Then the cavity is thoroughly dried and placed on the bone fragments of BAP. In the wound, the film acquires a gel-like structure and, enveloping the fragments, reliably mechanically protects them from microbial invasion. In addition, this form allows drugs to penetrate deep into the fracture gap and further along the bone channels into the thickness of the bone. An aseptic dressing is applied to the surgical wound.

 In the postoperative period, daily dressings of the initially purulent wound, physiotherapy treatment are carried out. When the inflammatory phenomena subside, which coincides with the time of resorption of the film (6-7 days), the wound is surgically treated and primary-delayed or secondary sutures are applied.

Example. Patient R. 24 years. Case history No. 972/3. He entered the Department of Maxillofacial Surgery VOKB 01/24/2000 with a diagnosis of "Fracture of the lower jaw on the left, complicated by primary suppuration of the bone wound. Subperiosteal abscess." From the anamnesis it is known that the injury was received on January 11, 2000. After the injury, he was not treated anywhere. 01/20/2000, noticed the appearance of edema in the lower parts of the buccal region, which was growing. The pain in the projection of the fracture line intensified. Body temperature increased to 37.8 ^o C. There was painful on palpation of the infiltrate along the transitional fold in the projection of teeth 33-36. The mucous membrane above it is edematous, hyperemic. Tooth 34 in the fracture line.

Upon admission, body temperature is 37.5 ^o C. Under local anesthesia, after reposition and fixation of the fragments by orthopedic methods, tooth 34 was removed from the fracture line and periostotomy was performed in projection 33-36. Received up to 3 ml of yellow thick pus. A tank was taken from the wound. The wound is treated with solutions of hydrogen peroxide and furatsilina. The hole of the extracted tooth is sutured with catgut. After drying the wound on bone fragments, a BAP is fixed, isolating the fracture line from a purulent wound. No antibacterial treatment was prescribed.

The first day after surgery. The patient's condition corresponds to the severity of the operation. Complaints of minor pain in the wound, swelling of the lower parts of the buccal region on the left. Body temperature in the morning 36.8 ^o C. The bite is fixed with rubber rods in a physiological ratio. The edges of the incision are moderately edematous, infiltrated. After diluting the edges of the wound, purulent discharge was obtained in an amount of about 1 ml. The film envelops the fracture line, thereby isolating it from the surrounding pus. The wound is treated with a solution of gibitana. On the second day, swelling of the cheeks decreased significantly. Temperature - 36.6 ^o C. The edges of the wound remain hyperemic, but the infiltration compared with the first day significantly regressed. When breeding the edges of the incision, scanty purulent-hemorrhagic discharge was obtained. A second tank was taken. sowing. The wound is treated with antiseptic solutions. The film is still firmly fixed on the bone wound. By the third day, the patient's condition is satisfactory. No pain in the wound. Swelling of the buccal region underwent a reverse development. In the wound appeared foci of granulation, a small amount of serous discharge. The film is fixed satisfactorily. The wound is treated with plivacept solution. On the fourth day, complaints of discomfort in the oral cavity associated with the presence of tires. Body temperature is normal. General condition is satisfactory. The wound is granulating. There is no discharge from the wound. Edema and infiltration were regressed. The mucous membrane is pale pink, slightly hyperemic in the scar area. On the fifth day, the patient was discharged from the hospital. Traumatic osteomyelitis in the patient did not develop.

 Thus, isolation of the fracture line from the surrounding purulent wound by means of a biologically active film with polyvalent pharmacological properties is a real way of actively preventing traumatic osteomyelitis of the lower jaw, allowing surgical treatment of the wound in the early stages of the patient’s admission. The risk of developing traumatic osteomyelitis of the lower jaw is reduced. The time spent in the hospital can be reduced by 2-3 days.

Claims (1)

1. Means for the prevention of traumatic osteomyelitis of the lower jaw based on a cellulose derivative and an antibacterial drug, characterized in that a 2% aqueous NaKMC solution is used as a cellulose derivative, and a 0.2% ciprofloxacin solution and 0, are used as an antibacterial drug. A 5% solution of metronidazole, in addition, the product contains methyluracil and hydroxyapatite, while the ingredients are taken in the following ratio:
2% NaCMC aqueous solution - 200 mg
0.2% ciprofloxacin solution - 5 mg (2.5 ml)
0.5% metronidazole solution - 5 mg (1 ml)
Methyluracil - 5 mg
Hydroxyapatite - 5 mg
Distilled water - 6500 mg (6.5 ml)
2. A method for the prevention of traumatic osteomyelitis of the lower jaw, which consists in draining the purulent focus, reposition and immobilization of fragments, and oral sanitation, characterized in that a biologically active film is applied to bone fragments for a period of 5-7 days, which isolates the bone wound from the surrounding purulent focus to complete healing of the wound.