Wound healing drug and surgical manasarova napkin

 

(57) Abstract:

The invention relates to medicine, namely to surgical wipes, used in the treatment of wounds and burns in all phases of wound healing. A gauze pad impregnated with a composition of the following composition, wt.%: gentamicin sulfate of 0.5 - 0.7 (in terms of active substance), natural biostimulant - extract collagen 43 - 58 glycerin 4.5 to 5.3 and purified water 52 - 36. Napkin with improved therapeutic properties, increased wettability provides prolonged therapeutic effect within 2 - 3 days. 2 S. and 2 C.p. F. table 4.

The invention relates to medicine, namely to the surgical wipes, multifunctional, used to treat wounds and burns in all phases of wound healing by application to wounds.

Known antimicrobial dressings Neotulle company Fisons (Germany) and Sofratulle company A. Roussel (Germany), which is a sterile napkins woven mesh substrate, impregnated with ointment neomycin or framycetin (synonym neomycin) based on petrolatum or white paraffin wax in combination with lanolin (Martindal the Etra Pharmacopoeia, London, 1978, v. 27, p.1159). However, these wipes contain the antibiotic neomycin, cosistently gram-negative microorganisms.

The lack of antimicrobial dressings Neotulle and Sofratulle is that they do not contain biologically active component, accelerating the reparative processes in the wound.

Known three-layer gauze napkin gaplus-containing woven on a net basis, impregnated with biologically active ingredient - hyaluronic acid, stimulates regenerative processes in the wound (THE 9358-004-12466809-96). However, the disadvantage of this armband is the lack of therapeutic effect, as the cloth does not contain antimicrobial substances. In addition, the cloth cannot be used on wounds with a large surface, as it is limited by size.

Known gauze, impregnated with sanguinarine, antimicrobial substances of vegetable origin and with a wide spectrum of antimicrobial activity. However, the cloth does not contain biostimulants regenerative processes in the wound (TU CHU 0.009.295.108, SP horos", Russia-Sweden).

The closest analogue is an antimicrobial dressing for the treatment of purulent wounds, representing a sterile cloth on knitted-mesh substrate open-cellular structure, impregnated with 0.1% gentamitsinovoy ointment (Tezy the suture materials". M: the Academy of medical Sciences, Institute of surgery. A. C. Wisniewski, 1989, S. 106-107, article Kagan E. H., Sinitsyna N. And., Dobysh C. C. and others, "Effectiveness of treatment of purulent wounds with antibacterial ointment bandages on the mesh substrate").

Gentamicin sulfate aminoglycoside antibiotic of the second generation, broad-spectrum antibacterial action, active when mixed infection and against Pseudomonas aeruginosa, resistance to it develops slowly.

However, this form of bandage with antibiotic as gentamicin sulfate, does not meet the requirements of surgical practice, because there is no bio-stimulating component and hydrophobic materials reduces the rate of wetting the bandage wound exudate, which reduces the draining properties of the bandage.

The objective of the invention is to obtain surgical wound dressings with antimicrobial activity and bio-stimulating tissue regeneration action to prevent complications and speed up the healing process clean wounds, treatment of burn wounds and festering infected wounds, improving therapeutic properties of the bandage and its wettability, maintaining the wound in a moist condition, the closure of one cloth RAS Belokany the result is achieved by that napkin is used woven mesh fabric - medical gauze, impregnated with a solution containing natural biostimulant reparative processes - collagen extract (patent N 2065745 from 27.06.1996. Bull. N 24) and antibacterial component, gentamicin sulfate, and glycerin as a plasticizer and a means of increasing the wettability of the napkin.

The solution for impregnation of napkins has the following composition, wt.%: gentamicin sulfate (in terms of active substance) of 0.5-0.7; glycerin distilled (GOST 6824-78, dynamite, higher or first grade) 4,5-5,3; extract collagen (TU 10.18.11.05-95) 43 to 58; purified water (FS 42-2619-89) 52-36.

The solution for impregnation was prepared as follows.

1. Gentamicin sulfate is dissolved in purified water at room temperature and under stirring paddle mixer for 15-20 min, then add the glycerin and stirred at the same speed for 5-10 minutes.

2. Then the solution is heated to 40-45oAnd load it with the collagen extract (EX), stirred for 20-30 min until complete dissolution.

The method of obtaining wipes is as follows.

1. The impregnated gauze. Gauze roll moves through about the impregnation, and through squeeze rolls to remove excess solution.

2. Drying Marley. Impregnated cloth gauze moves through a system of guide rollers drying at a temperature not exceeding 90oC.

3. Cutting gauze. The impregnated and dried fabric gauze moves through the mechanism of cutting and folding and cut into strips, which are then formed into a three-layer tape and wound on bobbins.

4. Cutting and packaging of the wipes. Bobbin after analysis on the uniformity of the impregnation and the content of gentamicin sulfate arrive at the packaging machine, where the gauze when moving on the conveyor is cut into individual wipes, which are then fed into the space between the upper and lower strips of paper with a plastic coating mechanism longitudinal welding, where the paper is welded along the side seams, and then it goes to the mechanism of transverse welding and cutting on the finished packaging wipes depending on size. Ready wipes individually wrapped sterile-rays at a dose of 19000 Gr. Gauze surgical three-layer cloth containing gentamicin from 11 to 16 mg - low, from 22 to 32 mg - average and from 29 to 42 mg - large, sterile and stable for two years when stored the ability of the proposed surgical wound wipes is a combination of woven mesh fabric with hydrophilic composition of the antibiotic gentamicin sulfate and biostimulant regenerative processes in the wound - extract collagen, which had not previously been used in surgical practice. This combination of gauze with a water-soluble composition provides water vapor permeability and drainage properties of the bandage, and prolonged antibacterial and biostimulating effect. In addition, the wipe can be used on extensive wounds due to its deployment.

In table. 2 the estimation of the properties of the surgical wound wipes depending on the percentages of the components of the impregnating solution.

In table. 3 given the rate of release of gentamicin sulphate from napkins.

Medico-biological studies of surgical wound tissues were carried out on outbred rats. Napkins were placed on a standard partial and full thickness wounds with generalized infectious process (see tab. 4). Monitor the clinical picture of the development of the hearth and purification of the festering wounds showed that wound healing was accelerated by 15-20% in all phases of wound healing, i.e., occurred on 4-5 days earlier than when using antimicrobial ointment dressings with 0.1% ointment gentamitsinovoy.

Microbiological and histological study showed that the application of granulation tissue and the appearance of epithelialization. The magnitude of the contraction of the wound/day is 7,37% of initial value wounds; to the 7th day is the reduction of microbial contamination of the wound below the "critical". Under antimicrobial ointment and a bandage from 0.1% ointment gentamitsinovoy cleansing occurred at a later date. At the same time under it was observed neutrophilic leukocytes in a state of severe degradation. Raney process is characterized by a more prolonged course and appearance of squamous cells only to the 11th day.

Conducted Toxicological testing surgical wound wipes and clinical trial in 200 patients of different age and sex with various purulent-inflammatory diseases of the skin and soft tissues and postoperative wounds.

Clinical observation on the basis of the State center dressing, suture and polymeric materials and the burn center at the Institute of surgery. A. C. Wisniewski RAMS showed that when using surgical wound wipes with gentamicin sulfate, and collagen extract treatment of purulent wounds more effectively, which provides a positive clinical dynamics in earlier periods.

The development of granulozitopenia known methods, namely, the use of gauze impregnated with gentamicin sulfate, and collagen extract, with different percentages of components within prescribed limits, for the treatment of wounds was significantly higher than the expected effect, as evidenced by the results of a clinical study.

Example 1. For the manufacture of surgical wound wipes take the gauze and medical solution for impregnation with the percentage of components in the lower interval.

Canvas Marley moves through the impregnating roller when fully immersed in a container with a solution, where the concentration of gentamicin sulfate 0.5%, glycerol 4,5%, EX 43% and purified water 52%. Excess solution presses the platen. Then the gauze passes mechanism of drying at a temperature not exceeding 90oSince, then is the mechanism of cutting and folding, after which comes the three-band width of 10 cm After analysis on the uniformity of the impregnation and the content of gentamicin sulfate, in which the cloth should not be less than 85% of the quantities specified in the technical specifications for this standard size, fabric gauze on the conveyor moving between two layers of paper laminated with polyethylene, cut into wolnym the seams and transverse to the weld with the simultaneous cutting into individual napkins. Wipes individually wrapped sterile-rays at a dose of 19000 Gr. Ready surgical wound wipes individually wrapped for single use meet the requirements of technical specifications, developed by NPO "Lita-Color", at the time of manufacture and after 2 years of storage.

Patient S. , 82 years. Diagnosis: long-term healing trophic ulcers. After careful washing of the wounds imposed surgical wound cloth with gentamicin sulfate, and collagen extract. Bandages soaked and well attached to the wound surface. The course of the wound process was evaluated according to the dynamic quantitative microbiological and cytological analysis methods.

According to the microbiological analysis revealed that the cleansing of wounds and reduction of microflora from 10310 microbial cells/cm2was observed on the 7th day. Three days after application wipes noted a decrease in the percentage of destruction of cells of granulation tissue, and by the 8th day the number of young fibroblasts increased by 35%, macrophages 45%, Poliplast 25%. Was observed more pronounced edge epithelialization. The use of other drugs with the La production of the surgical wound wipes use medical gauze and the solution for impregnation with the following percentage of ingredients: gentamicin sulfate 0,6; glycerin 5; EX 50 and purified water 44,4. Preparation tissues were carried out as in example 1. Ready wipes meet the requirements of technical specifications, developed by NPO "Lita-Color" as at the time of manufacture and after 2 years of storage.

Patient A., 43 years. Diagnosis: thermal burn chest II-III degree, 8% of the body surface. After removal of necrotic tissue treatment of burn wounds was performed using a surgical wound wipes. A control plot was covered with antibacterial ointment and a bandage with 0.1% ointment gentamitsinovoy. It was found that the wipes provide a sufficiently stable antimicrobial effect.

To 6-day microbial colonization of wounds decreased from 105up to 102microbial cells/cm2. By the 5th day of treatment the number of young fibroblasts increased by 38%, macrophage - 47% and Poliplast by 26%. The positive effect of napkins on the epithelization process. Cleansing wounds noted on 8 days, whereas the use of antimicrobial ointment dressings with 0.1% ointment gentamitsinovoy cleansing occurred on the 11th day, and the cells regenerative tissue appeared on the 13th day. In addition, when using antimicrobial ointment dressing change is an under the napkins were reduced by 4-5 days compared to control antimicrobial ointment and a bandage.

Example 3. For the manufacture of surgical wound wipes use medical gauze and the solution for impregnation with the following percentage of ingredients: gentamicin sulfate 0,7; glycerin 5,3; EX 58; purified water 36,0. Preparation wipes were carried out as in example 1. Ready wipes meet the requirements of technical specifications, developed by NPO "Lita-Color", at the time of manufacture and after 2 years of storage.

Patient P., 25 years. The diagnosis of purulent wound right leg as the result of a gunshot. After removal of necrotic tissue treatment of the wound was performed cloths pre-moistened with saline. During clinical observation, it was noted that on the 2nd day decreased the intensity of the inflammatory phenomena, on the 3rd day intensified the development of granulation tissue. By the 4th day clearly noticeable creeping epithelium at the wound edges, to the 5th day of treatment the number of young fibroblasts increased by 45%, macrophage - 40% and Poliplast - 30%. For the 8th day of wound healing was completed primary intention with the formation of a sufficiently elastic scar.

We offer surgical wound napkin in comparison with the known has the following primestone occur even under conditions not fully treated wounds, and provides positive clinical dynamics in earlier periods.

Instant wettability and optimal adhesion to the wound surface, regardless of the location of the wounds.

Wound healing occurs without the formation of rough keloid scars, during the initial tension forms a smooth, elastic enough scar.

The vapor permeability and retention effect wipes sufficiently provides aeration of the wound and the outflow of wound. The period of wound healing is reduced in General by 5-6 days.

The cloth provides a metered flow of the antibiotic to the wound and prolonged effect within 2-3 days, which reduces the number of dressings to 2-3 on the course of treatment. Can be used for the treatment of wounds of large areas while maintaining an equal number of wipes and dressings. Guarantees the stability and sterility.

1. Healing preparation containing an antibacterial agent and a biostimulant, glycerin and purified water, characterized in that it is made in the form of a hydrophilic composition containing as an antibacterial agent gentamicin sulfate, as biostimulant - collagen ECE matter)

Extract collagen - 43 - 58

Glycerin - 4,5 - 5,3

Purified water - 36 - 52

2. Surgical wound healing napkin made on a woven net basis, impregnated with a drug, wherein the drug is a composition comprising components in the following percentages, by weight.%:

Gentamicin sulfate of 0.5 - 0.7 (in terms of active substance)

Extract collagen - 43 - 58

Glycerin - 4,5 - 5,3

Purified water - 36 - 52

3. Napkin under item 2, characterized in that as the fabric base is used gauze.

4. Napkin under item 3, characterized in that it is impregnated drug and dried.

 

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