RU2848912C1 - Method for conservative stage treatment of trophic ulcers - Google Patents

Abstract

FIELD: medicine; surgery.

SUBSTANCE: invention can be used for the conservative treatment of trophic ulcers of venous and diabetic aetiology. Bandages are applied in stages with the application of local preparations. At the first stage, a bandage with an ointment preparation for external use containing the following is applied to the wound area: Chloramphenicol + Dioxomethyltetrahydropyrimidine. In the second stage, a bandage with an ointment for external use containing: Ofloxacin + Dioxomethyltetrahydropyrimidine + Lidocaine hydrochloride is applied to the wound area. In the third stage, a dressing with a powder for external use containing zinc bacitracin + neomycin sulphate is applied to the wound area. At the same time, in the second and third stages, a paste for external use containing zinc oxide is applied to the area around the wound, after which the second and third stages are alternated until the wound heals.

EFFECT: reduction of the duration of conservative treatment and increased rate of epithelialisation through phased, combined external therapy with the most optimal parameters.

1 cl, 2 ex

Description

Field of technology

The invention relates to medicine, and in particular to surgery, and can be used for the conservative treatment of local and circular, deep and superficial, primarily occurring and recurrent trophic ulcers of venous and diabetic etiology according to Wagner 1, 2 degrees.

State of the art.

According to data from various authors on the etiology, trophic ulcers occur with the following frequency: varicose - 52%; arterial - 14%; mixed - 13%; post-thrombophlebitic - 7%; post-traumatic - 6%; diabetic - 5%; neurotrophic - 1%; and others - 2% [V.S. Saveliev 2001, V.I. Dovnar 2009, S.V. Dudarev 2018, A.N. Plekhanov 2018 and others]. To date, the issue of trophic ulcer treatment remains open. Conservative therapy is often labor-intensive, time-consuming, ineffective, and costly. The disease affects 1-2% of working-age individuals and up to 6-7% of elderly patients. Up to 2.5 million people worldwide have skin integrity problems due to trophic ulcers on the feet and shins [M.A. Smagin 2018, A.A. Zhukov 2018, O.S. Popov 2011, A.N. Plekhanov 2018, etc.]. For a long time, both conservative and surgical methods have been used to treat trophic ulcers. Conservative methods included the use of various ointments: Apilak, Methyluracil, Oflomelid®, Solcoseryl, Panthenol, and others. The literature describes methods that include the use of nitric oxide, autologous plasma enriched with platelet lysate, stem cells, Unna dressings, and vacuum-assisted therapy. Among surgical interventions, surgical debridement with necrectomy by scraping or using a waterjet scalpel is most commonly used. All of these methods, when used alone, have shown limited effectiveness in practice, which impacts the duration of treatment.

A known art method for using an antimicrobial gel to treat infected wounds, burns, and trophic ulcers involves using a gel (HNP-1 0.00005 g PEG 12 dimethicone 100 ml Gelling agent 50 ml; Triethanolamine 20 ml; Purified water to 1000.0 ml), which is applied to the affected area of the skin 2-3 cm thick, 2 times a day. The gel is applied until the wound defect is epithelialized (Patent of the Russian Federation No. 2655522 dated July 18, 2017). The disadvantage of this method is the lack of free access to this gel and the lengthy healing time.

A known method for using a medicinal product for the treatment of microbial eczema, paraproctitis, burns, trophic ulcers, and other slow-healing wounds involves preparing a medicinal product from a 30-40% alcoholic propolis solution, sea buckthorn oil, St. John's wort oil, celandine juice, vinylin, lanolin, and petroleum jelly (Patent No. 2221550, December 2, 2004). This ointment is applied to infected, long-healing wounds and ulcers, including trophic and microbial eczema-affected skin areas, inflamed hemorrhoids, and by injection into the rectum. It is also used for paraproctitis. A disadvantage is the labor-intensive manufacturing process and the unavailability of a ready-made ointment.

A known method for treating long-standing trophic ulcers involves the use of a dialdehyde cellulose-based napkin with immobilized trypsin followed by irradiation (Patent No. 2195930 dated January 10, 2023). This method involves using a napkin with immobilized trypsin, additionally containing decamethoxin, impregnated with an aqueous solution of the "Photosens" photosensitizer at a concentration of 125-500 μg/ml. The napkin is kept on the ulcer for 24 hours and treated with NO-containing air-plasma flows for an exposure time of 10-15 s per 1 ^cm2 . The wound is irradiated with light with a wavelength of 670 nm, followed by daily exposure to NO-containing air-plasma flows for the same exposure duration. The disadvantage of this method is that its implementation requires special equipment, which is not available in medical institutions of various levels.

A prior art method uses a wound-healing agent comprising a gelling agent and purified mumiyo (Application RU 97112547/14 dated June 20, 1999). Galactomannan or glucomannan is selected as the gelling agent. One embodiment of the known wound-healing agent contains 1% galactomannan and 1% purified mumiyo, while another contains 2% glucomannan and 1% purified mumiyo. With the specified weight ratios of gelling agents and purified mumiyo, no consistent reduction in the healing time of purulent wounds or trophic ulcers was achieved. A disadvantage of this method is the lack of a consistent reduction in the healing time of purulent wounds or trophic ulcers.

The problem that the present invention is aimed at solving is the conservative treatment of trophic ulcers of venous and diabetic etiology.

Disclosure of invention

The technical result of the invention is the possibility of conservative treatment of trophic ulcers, including the staged use of ointment and powder dosage forms, which ensures the prevention of inflammatory phenomena in the wound and the acceleration of tissue regeneration and epithelialization processes.

The technical result is achieved by administering a three-stage treatment regimen to patients in an outpatient setting. Stage 1: During the first three days, a bandage is applied with an ointment containing an antibacterial and tissue regeneration-enhancing drug for external use: Chloramphenicol 7.5 mg + Dioxomethyltetrahydropyrimidine (Methyluracil) 40 mg (Levomecol®, Alfamecol, Dimicol, and other similar products) (ATC code D06C). It should be noted that this drug, due to its antibacterial action, promotes active cleansing of the wound surface and the appearance of the first granulation tissue. Second stage: starting on the 4th day and continuing for 5 days, apply a bandage with an ointment containing an antibacterial, local anesthetic, and tissue regeneration-enhancing drug for external use: Ofloxacin 10 mg + Dioxomethyltetrahydropyrimidine (Methyluracil) 40 mg + Lidocaine hydrochloride (as Monohydrate) 30 mg (Oflomelid®, ATX code D06BX). This ointment has a bactericidal effect, promotes microvascular dilation, and accelerates tissue regeneration and epithelialization. Starting on the fourth day and throughout the treatment period, apply a 3-cm perimeter of the skin around the wound, without touching the wound itself, using a paste containing zinc oxide (25 g) (ATC code D02AB), an astringent and drying agent for external use. Zinc paste has a disinfectant effect and also helps reduce exudation and oozing, which relieves inflammation and irritation, preventing the ulcer from spreading. Stage 3: Starting from the 9th day and lasting 5 days, apply a dressing with powder containing an antibacterial preparation for external use: Bacitracin (in the form of Bacitracin zinc) 250 IU (0.004583 g) + Neomycin (in the form of Neomycin sulfate) 5000 IU (0.008209 g) ("Baneocin®, Baneocin") ATX code - D06AX. The preparation helps prevent wound infection and promotes regeneration of the wound surface. In this case, stages 2 and 3 alternate until the wound heals. This method can significantly reduce the duration of conservative treatment of trophic ulcers of venous or diabetic etiology. The time of epithelialization in case of using this scheme is adjusted depending on the depth of the lesion and the prevalence of the process and on average ranges from 15 to 40 days.

Implementation of the invention

The method of staged conservative treatment of trophic ulcers of venous and diabetic etiology is carried out as follows:

1. At the first stage, a bandage with an ointment for external use containing: Chloramphenicol 7.5 mg + Dioxomethyltetrahydropyrimidine 40 mg is applied to the wound area for three days.

2. At the second stage, a bandage with an ointment preparation for external use is applied to the wound area, containing: Ofloxacin 10 mg + Dioxomethyltetrahydropyrimidine 40 mg + Lidocaine hydrochloride 30 mg, duration 5 days.

3. At the third stage, a bandage with powder for external use containing: Bacitracin zinc 0.004583 g + Neomycin sulfate 0.008209 g is applied to the wound area, duration 5 days.

4. At the second and third stages, a paste for external use containing: Zinc oxide 25 g is applied to the area around the wound.

Case Study 1. Patient K., 64, diagnosed with type 2 diabetes mellitus, diabetic foot syndrome, neuroischemic form, and a trophic ulcer of the lower third of the right leg. Upon examination, the ulcer area was 6 square centimeters. The patient received staged treatment as an outpatient. During the first 3 days, a dressing with Levomekol® ointment was applied. Starting on the 4th day and for 5 days, a dressing with Oflomelid® ointment was applied and the skin around the wound was treated with zinc paste for a 3-cm perimeter, without touching the wound itself. Starting on the 9th day and for 5 days, a dressing with Baneocin® powder was applied and the skin around the wound was treated with zinc paste for a 3-cm perimeter, without touching the wound itself. After 12 days from the start of treatment, the ulcer decreased in size to 4 square centimeters. Starting on the 14th day and continuing for 5 days, a dressing with Oflomelid® ointment was applied, and the skin around the wound was treated with zinc paste for a 3-cm perimeter, sparing the wound itself. On the 19th day, the wound had shrunk to 1.5 square centimeters. Starting on the 19th day and continuing for 5 days, a dressing with Baneocin® powder was applied, and the skin around the wound was treated with zinc paste for a 3-cm perimeter, sparing the wound itself. By the 24th day, the wound had healed.

Case Study 2. Patient K., 74, diagnosed with varicose veins of the lower extremities, class 6. CVI 3, trophic ulcer of the lower third of the left leg. The ulcer area upon examination was 20 square centimeters. The patient received staged treatment as an outpatient. During the first 3 days, a dressing with Levomekol® ointment was applied. Starting on the 4th day and for 5 days, a dressing with Oflomelid® ointment was applied and the skin around the wound was treated with zinc paste for a 3 cm perimeter, without touching the wound itself. Starting on the 9th day and for 5 days, a dressing with Baneocin® powder was applied and the skin around the wound was treated with zinc paste for a 3 cm perimeter, without touching the wound itself. Eleven days after the start of treatment, the ulcer had decreased in size to 18 square centimeters. Starting on the 14th day and continuing for 5 days, a dressing with Oflomelid® ointment was applied, and the skin around the wound was treated with zinc paste for a 3-cm perimeter, without touching the wound itself. On the 17th day, the wound had decreased to 15 square centimeters. Starting on the 19th day and continuing for 5 days, a dressing with Baneocin® powder was applied, and the skin around the wound was treated with zinc paste for a 3-cm perimeter, without touching the wound itself. On the 24th day, the wound had decreased to 10 square centimeters. Starting on the 24th day and continuing for 5 days, a dressing with Oflomelid® ointment was applied, and the skin around the wound was treated with zinc paste for a 3-cm perimeter, without touching the wound itself. On day 29 of treatment, the wound had shrunk to 6 square centimeters. Starting on day 34 and continuing for 5 days, a dressing with Baneocin® powder was applied, and the skin around the wound was treated with zinc paste for a 3-cm perimeter, sparing the wound itself. On day 39, the wound had shrunk to 2 square centimeters. Starting on day 39 and continuing for 5 days, a dressing with Oflomelid® ointment was applied, and the skin around the wound was treated with zinc paste for a 3-cm perimeter, sparing the wound itself. On day 44, the wound had healed.

Claims (1)

A method for the conservative treatment of trophic ulcers of venous and diabetic etiology, including the step-by-step application of dressings with the application of local preparations of the following dosage forms: ointment, powder and paste, characterized in that at the first stage, a dressing with an ointment preparation for external use is applied to the wound area, containing: Chloramphenicol 7.5 mg + Dioxomethyltetrahydropyrimidine 40 mg, duration three days; at the second stage, a dressing with an ointment preparation for external use is applied to the wound area, containing: Ofloxacin 10 mg + Dioxomethyltetrahydropyrimidine 40 mg + Lidocaine hydrochloride 30 mg, duration 5 days; At the 3rd stage, a dressing with powder for external use containing: Bacitracin zinc 0.004583 g + Neomycin sulfate 0.008209 g is applied to the wound area for 5 days, while at the second and third stages, a paste for external use containing Zinc oxide 25 g is applied to the area around the wound; after which the second and third stages alternate until the wound heals.