RU2545724C1 - Method of treating trophic ulcers and persistent septic wounds - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: wound surface is treated with 3.0-1.5% hydrogen peroxide; then keeping the wound wet, Ichthyosin dressing prepared by streptocide powder 0.5-2.5g and Ichthyol ointment 5.0-10.0g dissolved in castor oil 94.5-87.5ml is applied. The agent is applied once a day; the therapeutic course makes 16 days. That is combined with performing an integrated treatment.

EFFECT: invention provides both the antibacterial and anti-infectious, and local anti-inflammatory, local anaesthetic, wound-healing effects, improves the blood supply, stimulates the epidermis regeneration, intensifies the keratosis processes that enables accelerating the wound cleansing from the purulonecrosis process, and a length of preparation for aurografting.

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Description

The invention relates to medicine, namely to surgery, angiology, and can be used for topical treatment of trophic ulcers and long-term non-healing purulent wounds.

Trophic disorders and ulcers of the lower extremities are a serious complication of chronic lymphovenous and arterial insufficiency. Venous venous trophic ulcers account for 70% of all lower extremity ulcers, and their proportion is constantly growing. The frequency of venous etiology ulcers among the working population is 1-2%. In the elderly and senile age, this indicator increases to 5%. A significant decrease in the quality of life of patients suffering from this disease, long-term disability and significant treatment costs, which are not always effective, require the search for new effective methods of local treatment.

Analogs of the invention

The following methods are known for topical treatment of trophic ulcers and long-term non-healing purulent wounds using various ointments and agents:

1) streptonitol for the treatment of trophic ulcers, purulent wounds, burns; consisting of nitazole - 2.0, streptocide - 5.0, vaseline oil - 20.0, OS-20 - 1.2, alcohol of higher fatty synthetic fractions C ₁₆ -C ₂₁ or C ₂₀ - 6.8, 1, 2-propylene glycol - 29.25; water - 37.35; possessing antibacterial, stimulating regeneration properties (Paramonov B.A., Porebsky Y.O., Yablonsky V.G. Burns. A guide for doctors. - SPb., 2000. - P.141-143);

2) 10-20% ichthyol ointment for the treatment of inflammatory skin diseases (burns, erysipelas, eczema, etc.), myalgia, arthritis, neuralgia, and pelvic inflammatory diseases; consisting of the ammonium salt of sulphonic acids of shale oil and 10.5% organically bound sulfur, which has anti-inflammatory, local anesthetic and weak antiseptic properties (Mashkovsky MD “Medicines”. - 15th ed., revised., rev. and add. - M., 2007 .-- P.955);

3) streptocid ointment 10% or liniment streptocide 5% for the treatment of infected and purulent wounds, ulcers, burns I-II degree, cracks, purulent-inflammatory skin diseases; the first, consisting of 10 g streptocide and Vaseline 90 g, and the second - 5 g streptocide, fish oil 34 g, emulsifier, stabilizer and distilled water up to 100 g, which has anti-inflammatory and weak regeneration-promoting properties (Mashkovsky MD “Medicinal means. ”- 15th ed., revised., rev. and add. - M., 2007. - S.825);

4) liniment (emulsion) of synthomycin for the treatment of purulent wounds, purulent-inflammatory skin diseases, burns of the II-III degree; consisting of 1%, 5% or 10% synthomycin, castor oil, a special emulsifier, distilled water and a preservative that has antimicrobial and weak regeneration-promoting properties (Mashkovsky MD "Medicines". - 15th ed., revised. , rev. and add. - M., 2007 .-- P.817).

Criticism of analogues

The disadvantages of the above methods should be recognized:

1. Their lack of effectiveness, since the drugs used have weak anti-inflammatory, local anesthetic and antiseptic properties.

2. Allergic reactions and other side effects may occur.

3. Many drugs have a number of contraindications and are often not recommended for use due to the possible occurrence of complications.

4. The use of ointments has limitations, since their activity manifests itself in different ways in relation to certain diseases.

5. When using them, dermatitis, skin rash and skin irritation around wounds may occur.

6. Has a local irritant effect, expressed in redness of the skin or slight itching.

7. Contraindicated: with psoriasis, eczema, fungal skin lesions, with inhibition of blood formation.

Prototype of the invention

As a prototype, the closest to our invention is the balsamic liniment according to A.V. Vishnevsky (Mashkovsky MD "Medicines". - 15th ed., Rev., Rev. and add. - M., 2007. - P.955).

Prototype criticism

The essence of the prototype.

A.V. Vishnevsky ointment containing tar and xeroform in 3 parts, Aerosil 5 parts, castor oil 89 parts, has an antiseptic, weakly regenerative and slightly irritating effect. Used to treat wounds, ulcers, bedsores, burns.

However, in this ointment during the treatment, the following disadvantages were noted:

- Ointment does not have a sufficiently pronounced therapeutic effect.

- Perhaps a local irritant effect, manifested in redness of the skin or mild itching, a burning sensation and increased pain reaction, which contributes to the deterioration of local blood circulation.

- It is not effective enough because it has weak anti-inflammatory, local anesthetic and antiseptic properties.

- It cannot fully provide all the conditions necessary for regeneration, which are a balanced moist environment, activation of angiogenesis, the ability to accelerate the formation of collagen fibers, granulations and the migration of cell epithelium.

- Not effective enough in terms of removing excess exudate, more traumatic due to burning local pain, preserving the humidity of the environment and providing gas exchange.

The purpose of the invention

The aim of the invention is to increase the clinical effectiveness of treatment by reducing the healing time of a peptic ulcer, reducing the duration of adverse clinical manifestations of the course of the wound process, reducing the number of infectious complications and relapses of ulcer formation. The goal is achieved by the use of a new method for the local treatment of trophic ulcers and long-term non-healing purulent wounds, including daily dressings of a wound or ulcer with the proposed agent by preliminary cleaning of the wound surface with 3-1.5% hydrogen peroxide. The frequency of dressings once a day.

The essence of the invention lies in the fact that the tool contains components known in pharmacology of drugs that are used in everyday medical practice. As components of the drugs used: castor oil 94.5-87.5 ml, streptocide powder 0.5-2.5 g, ichthyol ointment 5.0-10.0 g.

The therapeutic action of the components of the drug is both antibacterial and anti-infectious, as well as local anti-inflammatory, local anesthetic, wound healing, as well as improving blood circulation to tissues, stimulating epidermal regeneration, enhancing keratinization processes.

Moreover, the proposed tool should be cheap, effective for local therapy with a wide range, devoid of negative side effects, and the use should not have contraindications and should be affordable, easy to use.

The method is implemented as follows. Preliminary assess the general and local clinical criteria of the patient, the phase of the wound process, the timing of wound cleansing, the appearance of granulations and their activity, bacteriological, cytological, planimetric indicators, etc.

The proposed method for the treatment of trophic ulcers and non-healing purulent wounds is the treatment of the wound surface with 3.0-1.5% hydrogen peroxide, then, without drying the wound, apply a bandage with Ichthiosin, obtained from streptocide powder 0.5-2, 5 g and ichthyol ointment 5.0-10.0 g dissolved in 94.5-87.5 ml of castor oil, the drug is applied 1 time per day, the course of treatment is 16 days.

The proposed tool, called "Ichthiosin", was used by us in the clinic for the local treatment of trophic ulcers and long-term non-healing purulent wounds for the first time. It is an oil composition prepared ex tempore according to the following recipe: pour 94.5-87.5 ml of castor oil into an enameled cup, put 5.0-10.0 g of ichthyol ointment into it and pour 0.5-2.5 g of streptocide powder, mix them with a spatula. Then we put the cup together with the obtained drug base in a water bath at a temperature of 60-70 ° C, continue to mix thoroughly the mixture until it becomes liquid, so that all incoming medicinal components are dissolved. Remove from the water bath, pour into a disinfected glass jar with a lid. Shelf life of 6 months or more in a cool dark place. The resulting tool is used in inpatient and outpatient practice. The proposed method is a cheap, effective method for local therapy with a wide range of applications, devoid of negative side effects, and the use should not have contraindications and should be affordable, easy to use.

The above formulations are indicated with min and max values of the components used in the preparation.

This optimal ratio was found in numerous experiments and confirmed in clinical observations.

All components included in the composition of the product are approved for use by the Ministry of Health of the Russian Federation (Mashkovsky MD “Medicines”. - 15th ed., Revised., Revised and supplemented - M., 2007. - 1206 p.). Separate use of the components of the agent for the treatment of trophic ulcers and long-term non-healing purulent wounds of the agent is ineffective. When using them in the proposed combination, a pronounced clinical effect was obtained, which is explained by the synergism of their action.

In the first (partially) and second phases of the wound healing process, the mixture is used for non-political, anti-inflammatory and regenerative purposes, while the concentration of active substances in it is maximum.

In the second and third phases of the wound healing process - to stimulate regeneration, to protect the wound surface from secondary infection and epithelization, while the concentration of active substances in it is minimal.

Indications for the use of this tool are trophic ulcers and long-term non-healing purulent wounds, etc. partially in the first, second and third phases of the wound healing process. It is desirable to use it in combination with hypertonic solutions and antiseptics in the first phase of the wound process.

A contraindication is only an allergy to the components of the mixture, which our patients did not have in any case. We used this tool even with severe allergic dermatitis in the wound healing zone, microbial, fungal and eczematous dermatitis.

Using the invention allows to obtain the following technical result.

Means "Ichthiosin" is effective for local treatment of trophic ulcers and long-term non-healing purulent wounds, etc., requiring the removal of pain, inflammatory response and stimulation of regeneration. The effectiveness of the tool is ensured by the selection of components that make up its active part, and their quantity.

The terms of treatment compared with the known drugs for local treatment are sharply reduced and are on average only 16 days per course. In this case, there are no side effects, in connection with which the contingent of patients and patients has expanded.

When using this tool, a marked improvement in the general and local clinical status is observed.

The tool can be used both for treatment and for the prevention of purulent-inflammatory reaction of the wound.

The proposed drug "Ichthiosin" was tested in polyclinic No. 6 of Makhachkala, the Geriatric Center of the Veterans Hospital of the Ministry of Health of the Republic of Dagestan, the surgical department of the Veterans Hospital of the RMC of the Ministry of Health of the Republic of Dagestan, the burn department of the Clinical Hospital of the Ministry of Health of the Republic of Dagestan.

A clinical study of the drug was conducted on 95 patients. With all indications, a positive therapeutic effect was noted. Negative side effects were not observed in any of the cases.

The technical result is achieved due to the combined use of the components included in the Ichthiosin agent, which together allowed us to obtain a therapeutic drug with anti-inflammatory, analgesic and wound healing effects, which is the basis for its widespread use in the treatment of trophic ulcers and long-term non-healing purulent wounds. The authors found that the Ichthiosin product contains components in such quantities that, when used together, provide the most pronounced therapeutic effect, and the used oil base helps to effectively maintain an optimal environment for good wound healing.

The difference between the proposed product from the prototype is that the product contains components of drugs known in pharmacology that are used in everyday medical practice, castor oil, streptocide powder, ichthyol ointment, and their combined use in the proposed combination due to the synergy of their action has a pronounced clinical effect, which dramatically reduces the treatment time compared with known drugs for local cheniya.

An example of a specific implementation of the method

The method proposed as an invention is used in the treatment of trophic ulcers and long-term non-healing purulent wounds in 95 patients in the surgical department of the Veterans Hospital of the RMC MH RD, the surgical room of the Clinic No. 6 of Makhachkala and the Geriatric Center of the Veterans Hospital of the MH RD. This method compares favorably with others in that the terms of preoperative preparation and inpatient treatment are reduced, which allows to obtain a significant economic effect. Reducing the duration of treatment occurs due to the acceleration of the phases of the wound healing process (faster cleansing of trophic ulcers and long-term non-healing purulent wounds, the appearance of granulations and marginal epithelization). Clinical data are confirmed by bacteriological, cytological, planimetric indicators and histological examination of biopsy samples of ulcers and wounds. It has been established that when Ichthiosin is used in the complex local treatment of trophic ulcers and long-term non-healing purulent wounds, they significantly weaken alternative phenomena and leukocyte infiltration in them, and cell reactions that provide regenerative phenomena develop faster. Favorable results are explained by the mutual potentiating anti-inflammatory and stimulating regenerative processes action of the components included in the Ichthyosin product. A clinical study of the regenerative effect of Ichthiosin was carried out in 48 patients with trophic ulcers and long non-healing purulent wounds (main group). In 24 patients of the first control group (only dressings with streptonitol were used locally in the treatment of trophic ulcers and long-term non-healing purulent wounds). Syntomycin liniment was used in 23 patients of the second control group in the local treatment of trophic ulcers and long-term non-healing purulent wounds, but in these patients bandages with 1% were used for 5-6 days before cleansing the trophic ulcer and long-time non-healing purulent wound from purulent-necrotic contents dioxidine solution. In patients of the main and control groups, according to indications, a similar complex treatment was carried out. The age of patients ranged from 50 to 85 years. Women were 67 (70.5%), men - 28 (29.5%). We performed local surgical interventions on the surface of trophic ulcers and long-term non-healing purulent wounds in the form of various skin plastic methods in 68 (71.6%). 27 patients were not exposed to skin plasty, 8 of them were small (less than 1 cm ² ) and 19 were medium-sized (from 3 to 10 cm ² ). They healed on their own. Surgical interventions from one to 4 times on the superficial, communicative and deep veins of the lower extremities suffered 85 (89.5%). For 10 (10.5%) patients, surgery on the venous system was not performed for various reasons. More favorable results were observed in patients of the main group compared with those of patients in the control groups. This was manifested in the fact that by the 2nd – 3rd day of treatment, they had improvement in their general condition, pain reduction, and in the control groups, after 5–6 and 8–10 days, respectively. Table 1 presents the results of general and local treatment of patients with trophic ulcers and long-term non-healing purulent wounds of the lower extremities, depending on the duration of observation and treatment option.

The table shows that the healing time of trophic ulcers and long non-healing purulent wounds in the main group (if they healed on their own) was reduced by more than 1.5 times; and the preparation time for autodermoplasty is 2 times.

Example 1: Patient K ..., 73 years old, male, applied with an extensive, long-term non-healing purulent wound on his right leg in the shin area on 03/05/2013 to the surgical department of the Veterans Hospital of the RMC MH RD. At admission, there was a wound with an area of 116 cm ² , with uneven edges, purulent-necrotic contents. Complex treatment was prescribed, local use of gauze dressings with Ichthiosin suspension. In the first week, the patient every day after the toilet of the wound with a 3% solution of hydrogen peroxide was applied a gauze with Ichthiosin, the dressing was changed once a day, and in the subsequent dressing was performed after the toilet of the wound with a 1.5% solution of hydrogen peroxide every other day. After 12 days, the wound healed. The patient was discharged for outpatient treatment. Upon repeated examination after a month, the wound healed completely with a tender scar.

Table 1 The results of treatment of patients with TN and DNGR of the lower extremities depending on the observation period and treatment option (M ± m) Indicators and criteria for the effectiveness of treatment The first control group n = 24 The second control group n = 23 The main group n = 48 Duration of purification from purulent-necrotic discharge, days. 9.7 ± 1.3 * 10.8 ± 2.2 5.1 ± 0.9 ** The timing of the appearance of granulations, days 5.6 ± 1.2 * 5.8 ± 1.2 3.4 ± 0.6 ** The timing of the onset of epithelization, days. 12.0 ± 1.7 * 14.8 ± 2.2 6.1 ± 0.6 ** Duration of skin plastics, days. 14.0 ± 1.3 * 15.8 ± 1.5 7.0 ± 1.2 ** The rate of healing of the wound surface,% 4.02 ± 0.3 * 3.1 ± 0.43 7.2 ± 0.8 ** Complete engraftment of flaps,% 88.9 86.9 98.5 Skin plastics applied,% 77.7 79.9 75.7 Sowing wound discharge: - staphylococcus 61.6% 66.4% 52.9% - mixed flora 38.4% 38.4% 47.1% Sterility of the wound on day 3 35% 21% 75% on day 5 49% 39% 89% on day 10 78% 69% 94% Dates of the operation, days 15.5 ± 5.3 * 17.5 ± 5.3 9.0 ± 1.2 ** The frequency of healing of ulcers,% 76.3% 56.3% 93.9% Relapse of an ulcer after 1 year,% 12.5% 13.04% 2.08% Average bed day, days 20 ± 5 * 25 ± 5 15 ± 3 ** Note: ^{*, **.} - differences in the values of indicators over time in the groups are statistically significant (p <0.001; 0.01)

Example 2: Patient P ..., 67 years old, female, was admitted to the clinic on January 24, 2010 with a diagnosis of post-thrombophlebitis, mixed form, chronic venous insufficiency of the 3rd degree, trophic ulcer in the lower third of the right lower leg along the anteromedial surface of size 12, 6 cm ² , dermatosclerosis and hyperpigmentation in the lower third of the right lower leg. Sick for 15 years, was repeatedly treated inpatiently and on an outpatient basis with varying success. A complex standard treatment was prescribed for a patient with venous pathology, and the Ichthiosine suspension was used locally. A patient with a 3% solution of hydrogen peroxide daily applied a gauze napkin with Ichthiosine to the trophic ulcer for a week after the toilet of the wound and external elastic compression was performed. In this case, the dressing was changed once a day, and in the subsequent dressing was carried out after the toilet wounds with a 1.5% solution of hydrogen peroxide. Dressings were performed without pain. By 5 days the ulcer cleared of purulent-necrotic plaque, pink, juicy granulation appeared. On the 12th day from the start of treatment, the area of the wound surface was reduced to 3.5 cm ² . By 16 days, the ulcer was healed and completely healed on its own. The patient was discharged for outpatient treatment on day 18 with an almost completely healed trophic ulcer. Upon re-examination after 6 months, the trophic ulcer healed completely with a tender scar. Subsequently, the patient made a combined gentle excision of the saphenous veins, subfascial dissociation of the communicating veins of the right lower leg. Relapse of the ulcer was not observed during the next 3 years of observation.

Thus, as the treatment shows, the Ichthiosin agent has a local anti-inflammatory effect, promotes resorption of the inflammatory process, dermatosclerosis and hyperpigmentation, exhibits analgesic and wound healing effects, which, with ease of use and the absence of side effects, allows the drug to be widely used in outpatient and inpatient settings.

Features of the invention, distinctive from the prototype

1. Means "Ichthiosin" has a fairly pronounced therapeutic effect.

2. The absence of locally irritating action, itching, burning sensation of the skin and wounds.

3. The drug has a pronounced anti-inflammatory, local anesthetic, antiseptic and wound healing effect.

4. When using the proposed combination, the drug provides all the conditions necessary for regeneration (balanced moist environment, activation of angiogenesis, the ability to accelerate the formation of collagen fibers, granulation and migration of cell epithelium).

5. The drug improves blood supply to tissues in and around an ulcer or wound, stimulates the regeneration of the epidermis, and enhances keratinization processes.

6. It is quite effective in terms of protecting the wound surface, removing excess exudate, preserving the humidity of the environment, ensuring gas exchange, temperature, eliminating the development of hypoxia and is atraumatic.

The positive effect of the application of the invention

The proposed tool, unlike other currently known drugs, can improve the results of local treatment of patients with trophic ulcers and long-term non-healing purulent wounds of the lower extremities. The results obtained from the use of this tool allow you to accelerate 1.5-2 times the cleaning of the wound from a purulent-necrotic process; provide rapid elimination of pathogenic microflora due to the bactericidal action of the drug; to activate the wound healing processes by stimulating the regeneration of resultant agents; reduce the degree of scar-sclerotic changes in paravasal tissues and provide optimal conditions for the mechanism of wound contraction due to the components that make up the drug. Reduces the time of treatment of patients, the cheapness of the drug and ease of use in any conditions, which also favorably affects the economic effect, which allows to improve the quality of treatment of this category of patients.

Claims (1)

A method of treating trophic ulcers and long-term non-healing purulent wounds, which is treating a wound with an antiseptic agent, characterized in that they treat the wound surface with 3.0-1.5% hydrogen peroxide, then, without drying the wound, apply a bandage with Ichthiosin, obtained from streptocide powder 0.5-2.5 g and ichthyol ointment 5.0-10.0 g dissolved in 94.5-87.5 ml of castor oil, the drug is applied 1 time per day, the course of treatment is 16 days.