information from the original articles of the doctor of medical sciences, professor Seleznev K. G., doctor of medical sciences, professor Fistal E. Ya., Fistal N. N., Speransky I. I, published in the methodological manual for physicians “Treatment and prevention of pathological scarring of wounds "
The problem of general and local treatment of burns, prevention and treatment of hypertrophic and keloid scars in burned, despite the presence of many medications, currently remains topical. This is due to the fact that, according to various authors, hypertrophic and keloid scars are found in 1.5 – 4.5% of the general population, and after the burns, depending on gender, nationality, etiology of the burn and treatment methods, these numbers range from 5, 8 to 17.3% [1, 2]. They lead to cosmetic defects, deformities of the limbs or individual parts of the body with impaired limb function, various aesthetic and social problems, a high percentage of disability of individuals surviving burns.
There are also certain difficulties in choosing the method of conservative treatment of burn wounds, especially with the development of inflammatory and allergic complications, the appearance of a tendency to form a pathological scar. Scarring is a normal reaction of an organism to trauma, without which no living organism can do. The scar occurs as a result of the body's response to the loss or destruction of skin structures through the formation of connective tissue. Scar tissue is not identical to the tissue that it replaces, and has lower functional qualities [11]. This substitution is always imperfect and leads, depending on the type of substitution, to various scars: atrophic, normotrophic, hypertrophic or keloid.
The cause of the formation of pathological scars are:
a) mechanical factors – improper and prolonged healing of wounds, especially in functionally active zones;
b) localization of wounds – the area of the hands, shoulders, popliteal fossa, sternum;
c) racial and individual factors – black skinned, red-haired;
d) metabolic disorders – diabetes, atherosclerosis, hypoproteinemia, hypovitaminosis;
e) factors of physical impact – x-ray and ultraviolet radiation;
f) infection and improper treatment of wounds;
g) the size of the scarring area and its permanent trauma in functionally active zones.
During wound healing the patient passes through the stages of coagulation, inflammation, matrix synthesis, angiogenesis, fibroplasia, epithelization, contraction, and scar modeling [8,9]. Scar formation also goes through several stages [10,12]:
• the first stage – inflammation and epithelization of the wound on the 7-10th day after receiving the wound. At this time, granulation tissue is weakly expressed, but the scar itself does not appear
• the second stage is the formation of a young scar, which lasts 20-30 days after the injury. Collagen and elastin fibers begin to form in granulation tissue. The increased blood supply to the scar remains; it acquires a deep pink color.
• the third stage is the formation of a “mature” scar which lasts from 1 to 3 months after the injury, the vessels completely disappear, collagen fibers line up along the lines of maximum tension. The scar becomes light and dense;
• the fourth stage - the final transformation of the scar, which lasts 4-12 months.
The time of scar formation is from 6 to 12 months, and according to some authors up to 18 months from the moment of wound epithelization.
The most commonly used medications and methods for the prevention and treatment of scars are silicone, compression clothing, various types of physiotherapy (ultrasound, laser, x-ray therapy, chemical and cryodermabrasion, etc.) and various medications for local conservative medical treatment. For local conservative treatment and prevention of scars of various etiologies, Melifon, Sandler Balm No. 3, Kelofibrase, Eleciua, Kelo-cote, MedGel and other medicines are used, but in the CIS and in Ukraine, “Contractubex” (gel and cream) and its analogue "Mederma" are most commonly used.
Despite the presence of a large number of medications and methods for the prevention and treatment of pathological scars, the frequency of their appearance and disability of burned individuals for this reason does not decrease. This is due to various factors such as an increase in the number of burned individuals, late referral of patients for medical care and prolonged non-pathogenetic self-medication, the inability to purchase highly effective drugs due to their high cost and impoverishment of the general population.
The pharmaceutical market of Ukraine annually receives up to 30 different medications for the treatment of burns directly or for all types of wounds, including burns. Recently, more and more attention has been paid to herbal medicines, which have therapeutic and prophylactic properties, contribute to the faster cleansing of wounds and preparing them for autodermoplasty, slow the development of pathological scars, etc. This has led us to study the local effects of “Contractubex” and “Dermofibraze” cream for scars of burn genesis at different periods of their formation.
The purpose and objectives of the study
The purpose of this study was a comparative clinical evaluation of the effectiveness of the use of “CONTRACTUBEX” and “DERMOFIBRAZE” cream for the prevention and treatment of pathological scars in patients undergoing inpatient and outpatient treatment in the Donetsk burn center of the State Institution named after them. VK. Gusak "of the AMS of Ukraine, determination of tolerability of these medications, identification of adverse reactions when using them.
The main objectives of the study were: 1. On the basis of clinical and laboratory studies to draw conclusions about the effectiveness of "Сontractubex" and cream "Dermofibraze" in the treatment of pathological scars at different periods of formation. 2. To develop patterns for the use of these medications, depending on the phase of the wound process and scarring of tissues.
Materials and research methods
For medical tests, 60 packs of “Dermofibraze” cream preparation manufactured by Georg Biosystems LLC, Ukraine, are presented, which is a tube with a uniform flesh-colored mass with a slight specific odor that easily spreads over the skin surface.
The protocols and instructions for the clinical trial of the drug “Dermofibraze” cream, individual registration forms, the Protocol of the State Sanitary and Epidemiological Expertise No. 05.05.02 - 04/902/2 of 11/22/2010 were also submitted.
Two medications were selected to be compaired for the treatment and prevention of scars: “Dermofibraze” cream and “Contractubex” gel used quite often in Ukraine and CIS countries because they differ in some components, namely:
active substance of “Contractubex” gel: per 100.0 g – onion extract 10 g, heparin 5000 IU, allantoin 1 g. Auxiliary substances of “Contractubex” gel: sorbic acid, methyl 4-hydroxybenzoate, perfume, DROM 2700, xanthan, polyethylene glycol 200, purified water. Gel “Contractubex” has a fibrinolytic, anti-inflammatory and anti-edematous effect due to the presence of onion extract, antithrombic, softening, moisturizing (due to the presence of heparin) and keratolytic effect (due to the presence of allantoin). The combination of these components enhances and complements each other, stimulates cell regeneration without hyperplasia, inhibits the proliferation of connective tissue cells and colloidal fibroblasts, and also promotes the regeneration of healthy skin cells, relieves skin itching, moisturizes scar tissue, and restores pigment exchange. The serum base of the “Contractubex” gel leaves a thin protective film on the surface of the scar, stretch marks (stretch marks), which protects the sensitive scar tissue from damage.
Active substances of “Dermofibrase” cream per 100.0 g: 25% thick extract of Allium Porrum - 6.5 g, 25% thick extract of Allium Cepa – 3.5 g, urea – 8.0 g, allantoin – 1.0 g, D-panthenol – 2.5 g, menthol – 0.2 g, camphor – 0.5 g, bodyaga extract – 0.5 g, polymethylsiloxane (silicone) – 7.0 g. Excipients – flavored liquid oil, higher alcohols, emulgin, propylene glycol, bronopol, methylparaben, propylparaben, butyloxyanisole, water.
Urea – with application onto the surface, healing and cleansing of wounds from necrotic tissues is accelerated, acts as an enhancer, that is, an amplifier for penetrating other active substances into the skin, has a water-binding effect, dissolves anticoagulants, reduces irritation and promotes skin regeneration [7].
Allantoin is a plant extract from wheat seedlings, chestnuts and comfrey. This is a crystalline compound found back in 1800 in a mixture of amnionic and allantoic fluids, hence its name allantoin, given by chemists Liebig and Weller. Upon contact with the skin, it has a keratolytic effect, softens the stratum corneum, promotes the rejection of dead cells, has an antioxidant effect, promotes cell regeneration, inhibits the growth of bacteria, helps the skin to be moisturized and supple. The effect of allantoin is due to the stimulation of leukocytosis (local effect), which makes the skin soft and silky. Therefore, it is an essential component in skin care, reducing the impact of adverse factors on the skin: solar radiation, wind, burns, mechanical injuries.
D-panthenol (dexpanthenol) – Dexpanthenol, a derivative of pantothenic acid, a water-soluble B-vitamin (provitamin B5), is an integral part of coenzyme A, which is necessary for carbohydrate, fat and protein metabolism, which plays a large role in acetylation and oxidation. It supports the normal function of the epithelium, stimulates skin regeneration, normalizes cellular metabolism, increases the strength of collagen fibers, activates the proliferation of fibroblasts, and reduces skin itching. When applied topically, dexpanthenol is rapidly absorbed and pantothenic acid is converted, which has a regenerative and weak anti-inflammatory, dermatoprotective effect. The optimal molecular weight, hydrophilicity and low polarity make it possible for D-panthenol to penetrate into all skin layers [3,4]. Dexpanthenol also has a moisturizing effect, increasing the hydration of the stratum corneum of the epidermis and reducing transepidermal fluid loss, which helps to soften the skin, reducing its cracking and increasing elasticity, which is impaired by pathological scarring [5]
Menthol has a locally irritating, some local antimicrobial and anti-inflammatory effect, helps to reduce pain and local itching. Local action is accompanied by a narrowing of blood vessels, a feeling of cold, which turns into a light burning and tingling sensation, improves trophic tissue.
Camphora is a terpenoid, a ketone of the terpene series, obtained from essential oils of camphor laurel, basil, wormwood, rosemary, and also semi-synthetically from fir oil. When applied topically, it causes narrowing of the peripheral blood vessels of the skin, inhibits platelet aggregation, like menthol, selectively irritates cold receptors and thus reduces itching [6].
Extractum Spongilla lacustris is obtained from a freshwater vegetable sponge, which in nature acts as a water filter. Locally, it has anti-inflammatory, irritating and anti-infective action. Since ancient times, it is used against hematomas and to quickly eliminate bruises. The active substances of the giardia quickly and deeply penetrate the tissues, strengthen and increase the tone of the veins and capillaries, normalize the metabolism in the connective tissue, eliminate edema and have analgesic properties.
Polymethylsiloxane (silicone) forms a non-oil protective layer that repels water and contains irritating ingredients in the water, but at the same time allows the skin to breathe. They contain from 3 to 9 silicon molecules, contributing to the healing of wounds.
The direct results of treatment of 63 patients who suffered superficial burns of various localization and area of the lesion, who completed inpatient or outpatient treatment in the department of thermal lesions of the Institute of Emergency and Reconstructive Surgery named after. VK. Gusak of the Academy of Medical Sciences of Ukraine also had signs of the onset of hypertrophic scar development.
Patients were divided into two groups. The first group – 23 patients who suffered epidermal burns, was treated with applying “Dermofibraze” cream 2-3 times a day to the areas of hypertrophy of healing wounds. 4 of them, the cream was applied to small residual wounds among the hypertrophic sites of scarring of epidermal burns. The preparation was applied to the burned surface daily after the toilet with a damp cloth moistened with furatsilin or 2% boric acid, a uniform layer of 1-2-3 mm, two layers of dry sterile gauze cloth on top and fixing with a gauze bandage. The course of treatment ranged from 20 to 30 days of application and from 3 to 10 days in the form of dressings for residual wounds.
The second group (comparison group) – 40 individuals who also suffered epidermal burns in the next 3-6 months after the start of scarring and received topical treatment with the medication “Contractubex” (Merz Pharmaceuticals GmbH, Franrfurt) by rubbing it into hypertrophic areas or already formed scars in terms similar to patients of the first group.
The age of patients ranged from 8 to 60 years. The etiological factor of thermal damage was flame – in 18 patients, hot liquids – in 45 victims.
The groups were created arbitrarily, as the victims were discharged from the hospital or when they were consulted by a combustiologist of the burn center. The clinical characteristics of the observed groups in age and quality terms were completely comparable, which made it possible to conduct a comparative analysis in the future.
When taking into account the effectiveness of treatment, the patient's sensations, changes in color, humidity, size and elasticity (density) of hypertrophy areas and tender hypertrophic scars, skin mobility in relation to the underlying tissues, the presence of itching and sensitivity in these places were taken into account. The absence or reduction of itching in the area of hypertrophization, an increase in mobility in relation to the underlying tissues, and the disappearance of a feeling of constriction and paresthesia were considered effective.
The effectiveness of the treatment was evaluated on the basis of subjective (visual assessment of the state of hypertrophy sites and formed scars, pain and itching in the area of scars and surrounding tissues, uniformity and pigmentation of the studied areas) and objective (scar size, sensitivity – pain and tactile, density and mobility) criteria according to the universal evaluation scale of scars [1].
Before and after treatment, on 7-8 days and after the end of treatment, all patients underwent general and biochemical analyzes of blood and urine, temperature, pulse, and pressure.
Results and discussion
For patients of the first group (n-10), who began treatment of hypertrophic areas of healed burn wounds immediately after the first signs of the development of a pathological scar appeared, after 2 weeks there was a decrease in the protrusion of the scar above the skin level. The scar became softer, mobile, and with continued treatment up to 5-6 weeks, signs of ongoing pathological scarring were not observed. There was also a decrease in the area of the scar by 15-20% compared with the moment of treatment initiation. Those patients who started using the “Dermofibraze” Cream with a formed pathological scar after 3-6 months (immature red hypertrophic scar) from the moment of obvious signs of hypertrophy of the healed areas (n-9), similar changes appeared only after 40-50 days of rubbing cream 2 times a day. In this case, the flattening of the scar was less pronounced, the mobility of the hypertrophied area with respect to the underlying tissues appeared.
In patients of the first group (n-4), who started treatment with the formed pathological scar (2-5 years after the formed scar), flattening and mobility of the scar were weak, but they noted the disappearance or reduction of dryness and skin itching in the area of pathological scarring, the skin took a paler color, became wet compared with the start of treatment.
Patients of the second group (n-40) are characterized by the appearance of a feeling of dryness in places of hypertrophization or an already formed scar, and in 17 patients, an increase in skin itching was noted. 5 people stopped using "Contractubex" due to itching and dryness of the scar, which were not eliminated by taking sedatives and antihistamines and the use of moisturizing creams.
In those patients who continued the treatment course recommended by the instructions (2-3 months), with early use, a decrease in the protruding areas of hypertrophy and a decrease in the area of the scar by 7-10% was noted, the appearance of mobility of these areas in relation to the underlying tissues, itchy skin was maintained, which was evaluated according to the level system, 2-3 points. Similar results were obtained in patients with unripened or formed pathological scars.
When prescribing "Dermofibraze", it is necessary to take into account its safety and effectiveness, the absence of side effects, the possibility of prolonged use and applying it to large areas of scarred skin lesions without systemic exposure, ease of use and affordable price. One should not expect a momentary effect from the local use of the medication, since its effect manifests itself after 2–3 weeks and is supported (fixed) with early and long-term use in patients with the onset of the formation of pathological scarring of the skin after various injuries.
Conclusions and recommendations
1. As shown by clinical and laboratory observations, the preparation “Dermofibraze” cream can be used to prevent the development of pathological scars at the sites of epithelization of superficial burns.
2. “Dermofibraze” cream is satisfactorily tolerated by patients, we did not observe side effects in the victims of the study group. It does not cause painful and uncomfortable sensations when using it, but rather has an analgesic effect.
3. “Dermofibraze” cream has a convenient packaging, which allows you to dose the consumption of the drug and fully use the contents of the tube.
4. We consider it advisable to use “Dermofibraze” cream in the early prevention and treatment of pathological hypertrophy of healed superficial burns.
5. We consider it appropriate to continue the study of the use of “Dermofibraze” cream in combustiology to address questions about their effectiveness in the areas of transplantation of dermal flaps, long-term results in patients with thermal lesions.
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