Adhesive treatment composition

 

(57) Abstract:

The invention relates to medicine and can be used for the treatment and prevention of complications in patients with operating and random superficial wounds. The invention consists in that the adhesive composition comprises N-(-oxyethyl)-4,6-dimethylpyrimidin-2 (ksimedon), benzocaine, hydrocortisone hemisuccinate, boric acid on the adhesive base, for example glue BF-6, and active pharmacological substances at a specific ratio of components. The invention provides a reduction in the duration of prophylaxis and treatment of microtraumas. table 2.

The invention relates to medicine, namely to the treatment of microtraumas.

Despite significant advances in the treatment of industrial and domestic injuries, treatment and prevention of secondary contamination of surface wounds remains far from resolved. Particularly noteworthy are the methods peculiar to the conservation of the wound, which is essential in the early stages of treatment, such as prehospital and in the provision of aid and self-help.

When small superficial wounds, scratches treatment and preventive effect. Applying an antiseptic on the wound most justified in the early stages of getting an open micro-injuries in the home and in the workplace. This simple technique of performing a medical procedure is an effective measure for prevention of purulent-inflammatory diseases.

Early closure, for example, by using neutral, powder (talc and others ), sulfidina, nitrofuranov shallow wounds with minimal loss of tissue allows you to create a dry scab, protecting tissue defect from secondary infection and external stimuli (Kurmangaliev S. M. Purulent infection in surgery. - M.: "Medicine". 1985. - 272 S.; Pods Century. And. Purulent surgery. - M.: Medgiz, 1962. - 358 S.).

In surgical practice is widely used biological antiseptic, hemostatic and protective equipment: collagen and cellulose sponge, dry plasma, antibiotics, fibrin glue, etc. (Isakov, Y. F. et al. The treatment of wounds in children. - M.: Medicine, 1990. - 192 S.; Wounds and wound infection /edited by M. I. Kuzina, and B. M. Kostyuchenok. - M.: Medicine, 1981. - 688 C.). Local preventive treatment should be considered as an auxiliary event at a certain stage of wound process, a positive effect on further shivlani: BF-2 with formalin EOF-6 and VB-6 monomitinom; collodion with furatsilina and ethyl alcohol and other drugs (tannin, diode, zinc oxide, terramycin, chloramphenicol, castor oil etc) on colloidal basis (the Khitrov F. M., Mammoths, P. Successes of plastic surgery. - M.: Publishing house "Knowledge", 1965. - 61 C.).

It is also known topical application of antibiotics, sulfonamides in the form of powders. However, these medicines for local use is not very effective, quickly lose their activity, cause allergies and dramatically inhibit the growth and maturation of granulation in the wound (Kamaev M. F. Infected wound and its treatment. - M.: Medicine, 1970).

You should allocate created film-forming composition of chemical substances with protective and curative properties that accelerate tissue regeneration and wound healing by diffusion of the drug from the film in the tissue, which is achieved by the inclusion of dimethyl sulfoxide (DMSO) (MITYC I. I., Brown, C. T. , Bedenko B., the Experience of the aerosol application of polymeric bandages //Klin.hir. - 1981.- N 1.- S. 33-34/.

Proposed polymerizable film-forming composition includes adhesive VF - 10%, ceriel 25% dimethylsulfoxide (Dimexidum, DMSO) - 10%, ethyl ester - 55% with dobavleniyu and testimony - antibiotics (penicillin 1 million UNITS). Scientifically unfounded the drugs over-saturation of the proposed composition of the polymer film coating, taken as a prototype, designed for ex evantibus, has many disadvantages, as evidenced by many of their own observations and reports in the literature:

- irrational selection of antibiotics: nitrofuranov, sulfonamides and antibiotics leads to antagonistic action, often this combination can be toxic (Pods Century. And., Postyshev C. K., Pods Y. C. Guide purulent surgery. - M.: Medicine, 1984. - S. 30-34);

method of local application of antibiotics has not received the distribution not only because of the low efficiency, due to their rapid destructible wound in content, the rapid development of antibiotic resistance of microorganisms, but also the frequent occurrence of local and systemic allergic reactions, ranging from anaphylactic shock to lung lesions (Ant I. A., Kozmin C. D., Kudrin A. N. The incompatibility of drugs. - M.: Medicine, 1978. - S. 158-167; Schmitt Century, Heftig Century, Kuzin, M. I. General surgery. - M.: Medicine, 1985; Leipzig, 1964. - T. 2. - S. 68-72);

our data show that the time after the injury) in the wound, having a potentiating effect, providing total Aleshchenko effect;

- DMSO (different dilutions) in 80% of the observed patients led to skin irritation in parabolani area, often to the Genesis of persistent signs of dermatitis that delayed the healing time of wounds up to 20 days;

The DHS has an unpleasant odor;

- short duration of the protective properties of the coating, its resistance does not exceed 30 hours, after which the cracks, and it requires almost daily gluing;

- local use nitrofuranovye compounds (furatsilin, furagin, furadonin) do not have antimicrobial activity (as placebo), but often lead to allergic reactions (itching, swelling, etc.);

in connection with pronounced irritating properties are severely limited local use (Mashkovsky M. D. Medicines. - M.: Medicine. - 1984. - T. 2. - S. 139).

Very low (0.9%) solubility methyluracil in water, alcohol (Mashkovsky, M. D., ibid - S. 138) does not allow to create in the adhesive composition and content in wound sufficiently high therapeutic concentrations (5-10%) makes it a local therapeutic beeffectively in the form of solutions, powders, dost the, prototip has significant disadvantages: low regenerative capacity, lack of analgesic, antibacterial and anti-inflammatory effect, a common Allergy that delays the timing of treatment of wounds.

The purpose of the invention is the creation of a new, more effective therapeutic compositions, reducing the time for the prevention and treatment of microtraumas.

This goal is achieved by the fact that the adhesive treatment composition comprises N-(-oxyethyl)-4,6-dimethylpyrimidin-2 (ksimedon), benzocaine, hydrocortisone hemisuccinate, boric acid and adhesive, e.g. glue EOF-6, with the following content of components, respectively, wt.%:

Ksimedon - 5-10

Benzocaine - 4-5

Hydrocortisone hemisuccinate - 0,09-0,13

Boric acid - 3-4

Glue EOF-6 - Rest

We offer adhesive composition - CALIBER (represented by the abbreviated name means the combination of the initial letters of the main active ingredients of the adhesive composition contains a highly effective chemical and biological pharmacological tools that provides fast and reliable shelter wounds, conservation, protects it from secondary contamination and direct repair the VA RF 287 N from 07.12.93, entered in the Register of medicinal products authorized for use in medical practice and production. Our early studies in the experiment and in the clinic showed that ksimedon when topically applied in the form of a 5-10% solution of the powder in the treatment of wounds has healing and antibacterial effects, which significantly potentiated the main pharmacological action of boric acid. Evidence-based is the inclusion of this dosage form hydrocortisone hemisuccinate (low content).

The use of glucocorticoid hormone low dose allows you to completely avoid side effects, reaching a high of his true ability and reparative regeneration of tissues. Our research suggests a positive local impact of hormone in small concentrations.

You should note that the effect achieved by the composition CALIBER, is not the simple sum of the effects of its components, and this effect is significantly more pronounced as the potency and spectrum of activity.

The process of making the proposed adhesive composition was carried out according videosjenny methods the State is 3. - S.).

Adhesive medical-preventive composition is applied as follows. The skin around the wound smeared with ethyl alcohol (70-96o) or 1-2% alcohol solution of iodine - toilet wounds. The wound and skin dry sterile gauze cloth. Small gauze ball, preferably the side with the smooth side of a surgical instrument (curved hemostatic clip, spatula, etc.), applied to the wound (2 times), capturing and partially surrounding skin (1-1,5 cm) of the adhesive composition. In this case, all the wound will be sealed. In the following days, in the absence of complete epithelialization of the wound, the procedure of applying adhesive repeat that sometimes occurs on 6-7 day.

The test results of preventive and curative effectiveness of the adhesive compositions obtained in the outpatient treatment of 50 patients with superficial skin accidental and operational wounds, scratches through different time (from 5 minutes to 6 hours) after the injury.

In the hospital, the adhesive composition used in 35 patients for closing postoperative (25) tightly defensive wounds and random (10) surface uninfected wounds, abrasions, and scratches.

Experimental group.

After application to the wound CALIBER formed of a transparent elastic film, which throughout the period of treatment is not subjected to deformation, destruction. The integrity of the film was kept for 5-6 days, i.e. in the vast majority until complete healing of the tissue defect. This eliminates the need to impose gauze bandage.

Observations though and showed the permeability of the polymer coating CALIBER for ultraviolet (UV) rays, but it was moderately reduced, thereby providing possible substantiated doses of UV-irradiation of the tissue defect. The technique of exercise daily physiotherapy procedures compared to traditional was simplified, but with increased therapeutic and economic efficiency: since onpreupdate contamination during irradiation, at the same time providing wound healing and antimicrobial activity. In addition, the conditions for dynamic monitoring of the progress of wound healing.

Application CALIBER resulted in 1.5-2 min to the relief of pain that did not reduce the activity of the patient, did not violate sleep, appetite and performance in 75% of cases. Only a few patients (5%), were in the hospital and after surgery on an outpatient basis, with the localization of the damage in hands or feet with the specific labour forced to stop their work by their conversion to sick leave. The control patients performance was preserved in 30%, in 20% of patients interrupted the constant work with the release on the sick list. The pain was delayed until days or more sleep disorders and appetite.

In the test result clinical effectiveness CALIBER also found that in the experimental group the healing process flows with less severe signs of inflammation than in control. The course of the wound process is characterized by the reduction of 2 days exudative phase without General and local signs of Allergy, maceration, contact eczematous dermatitis (control these symptoms was noted in 14 patients), and 4-5th day, the swelling of Octoberfest, which is quickly covered by the national Academy of Sciences of tissue a scab. After removal of the film (5-6 days), when this happened and rejection thin elastic scab, the wound defect is filled with smooth granulation tissue covered with epithelium. Complete wound healing in the control comes on the 7-8th day, as inflammation and damage in the tissues accompanied by the formation of more pronounced swelling, suppuration formed under the scab and the subsequent tendency to rejection. If suppuration in the control was observed in 117 patients, the experience of only 4. The subjects of the experimental group is formed inconspicuous scar without the tendency to form keloid zone that occurred in the control group (table.2).

EXAMPLE 1.

Patient A., 1961 R., entered 22.05.2000, 5 hours after head trauma (hit house on the door jamb). In the parietal region has a skin wound with smooth edges and a length of 5 see the recent Divergence slightly, about 1 mm. Wound clean, not bleeding. The surrounding skin (alopecia) is treated with ethyl 70oalcohol, the wound is washed with 3% hydrogen peroxide solution, drained. Wound throughout the proposed closed the adhesive composition in the following ratio, wt. is th BF-6 - Else

On the 6th day was complete wound healing by epithelialization with education inconspicuous whitish line. Any complications during outpatient treatment was not observed with preserving the integrity of the polymer coating.

EXAMPLE 2.

Patient Z., 43 years old, 10.03.1999, turned to the clinic after 20 minutes of receipt of street injuries knife with a diagnosis of incised wound to the rear of the left hand. Objectively on the back surface of the left hand is determined by linear skin narrow longitudinal wound with smooth edges, a length of 4.5 cm with a moderate stop the bleeding. On the last testified strip of red blood clot along the entire length of the wound. Processed skin around the wound with 0.5% alcoholic chlorhexidine, the wound is washed with 3% aqueous hydrogen peroxide solution, drained and closed by Kaibara in the following ratio, wt.%:

Ksimedon - 10

Benzocaine - 5

Hydrocortisone hemisuccinate - 0,13

Boric acid - 4

Glue EOF-6 - Rest

On the 5th day of the polymer film is removed. Complete healing of the wound. The patient was examined in a month. The scar is visible with difficulty, because the colour is equalized with the surrounding skin, which in Edna.

EXAMPLE 3.

Patient C., 34, entered 04.04.2000, with a deep scratch on the back of the neck after 2.5 hours of domestic trauma nail. Abrasion penetrates through the entire thickness of the skin. Produced toilet skin and defect with the application Kaibara in the following ratio, wt.%:

Ksimedon - 7,5

Benzocaine - 4,5

Hydrocortisone hemisuccinate - 0,11

Boric acid - 3,5

Glue EOF-6 - Rest

On the 6th day, the film is easily removed. The wound healed completely with the formation of the tender scar, which when viewed in 1.5 months is not noticeable. Movement of the neck is not limited.

Thus, the proposed structure of the polymer film coating on its therapeutic and prophylactic efficacy is not simply the sum of its components. Recommended adhesive composition allows a technically simple and reliable to perform prehospital conservation of the wound, thus preventing a secondary infection, protecting the wound from further injury, and create conditions for dynamic continuous monitoring of the wound during treatment during the changing of dressings, motions, etc. Considering the fact that microtrauma in the overwhelming its great gipertroficskih scars well-known, of great importance cosmetic result that the patients of the experimental group is significantly higher than in control. Thus, in the experimental group Genesis of keloid and hypertrophic scars were observed, at the same time in the control accordingly they are stated in 2 and in 4 cases.

Adhesive therapeutic and prophylactic composition for the treatment and prevention of secondary contamination microtraumas that contains a valid therapeutic composition and glue BF-6, characterized in that as a valid therapeutic compositions it contains Ksimedon, benzocaine, hydrocortisone hemisuccinate, boric acid in the following ratio, wt.%:

N-(-Oxyethyl)-4,6-dimethylpyrimidin-2 (ksimedon) - 5-10

Benzocaine - 4-5

Hydrocortisone hemisuccinate - 0,09-0,13

Boric acid - 3-4

Glue BF-6 - Else.

 

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