Bioactive hydrogel wound coating

FIELD: medicine.

SUBSTANCE: what is described is a bioactive wound coating of a hydrogel nanocomposite, which contains antimicrobial and antioxidant ingredients: silver-modified montmorillonite and fullerenol used to optimise the clinical course of the wound process, to prevent and suppress a wound infection. The wound coating can be used to treat gun-shot injuries, severe mechanical injuries, infected and uninfected wounds, including septic and persistent, granulating wounds following deep thermal, chemical and radioactive burns, in the combined therapy of trophic ulcers and bed sores at hospital, in the outpatient setting and in the field. The wound coating is elastic, not fragmented in dressing that facilitates wound care. A high sorption ability of the wound coating matrix, including of coarse-molecular ingredients of the wound effluent, provides the fast elimination of the wound bed. Using the hydrogel, i.e. possessing high degree of hydration, the wound coating meets the modern wound management in the humid medium.

EFFECT: optimum conditions for the early activation of the repair processes.

5 dwg, 2 tbl, 4 ex


The invention relates to medicine, namely to surgery, is intended for the local treatment of wounds in the inflammatory phase of wound healing process. Bioactive wound coating based hydrogel nanocomposite contains a complex of bioactive drugs to optimize the course of wound healing, prevention of the development and suppression of wound infection. The wound covering may be used for the treatment of gunshot wounds, wounds in severe mechanical trauma, uninfected and infected wounds, including purulent and nonhealing, granulating wounds after deep thermal, chemical and radiation burns in treatment of trophic ulcers in inpatient, outpatient and field conditions.

Well-known domestic coverage on the basis of sodium alginate, which is a natural hydrogel of origin: Coletex-gel-DNA containing Derinat (sodium desoxyribonucleate) and Coletex-gel-DNA-L" - Derinat and lidocaine. It is recommended to apply the coating for the prevention and treatment of radiation reactions and injuries of the mucous membranes (oral cavity and oropharyngeal, bladder, rectum, vagina, etc.) during and/or after the radiation therapy, and for treatment of nonhealing wounds and trophic ulcers, household burns [RF patent 2483755, LLC "Coleta�with", 2006]. However, weak wound healing activity and the absence of antimicrobial action significantly reduces the possibility of wide application of these hydrogels in medical practice.

Known dressings comprising a polymeric film coated with the surface layer of the polymer hydrogel. Film is made of a biocompatible optically transparent polymer with through holes of diameter D=0.01 to 3.0 mm and a density of N=(103=109)1/cm2and as the polymer of the hydrogel caused hydrogel based on chitosan. Dressings prevents penetration to the wound microorganisms, provides bacteriostatic action in the wound, allows you to visually monitor the processes occurring in the wound, and is conveniently attached to the wound surface [RF patent 2270646, LLC "Folium", 2006].

Common shortcomings of the presented coatings are relatively low sorption capacity, significant reduction in the strength of the matrix during the swelling, the lack of absorptive capacity in relation to macromolecular components of wound exudate and microbial flora.

The closest to the claimed invention are synthetic hydrogel coatings brand "APOLLO-PACK-AM", "APOLLO-PAK-AI", created on the basis of a copolymer of acrylamide and acrylic acid with addition of antiseptics mi�of amitina or yodovidona and the local anesthetic amylocaine. The hydrogels also have low sorption capacity of 2-3 g/G. Coatings contain antimicrobial and analgesic drugs, but do not contain antioxidant agents that significantly reduces their effectiveness in marked inflammation [TU 9393-002-42965160-2009, "th "APOLLO", 2009;]. Essential structural disadvantage of these gels is that a significant portion of the gel, when opening the package remains on the inner surface (50%), and is not transferred to the wound with the mesh carrier. These wound dressings have a low pH at 5.5 to 6.0, in the context of local tissue acidosis also reduces their effectiveness.

Thus, the need to develop ways of immobilization of bio-active components in the matrix-media-based hydrogels of different chemical nature, which provides prolonged release of the latest in wound bed, while maintaining their high sorption capacity and mechanical strength, remains.

Technical challenge and a positive result of the present invention to provide a bioactive hydrogel wound dressings containing pathogenetically substantiated the complex of therapeutic drugs, local application which will optimise�VAT the course of wound healing, to reduce healing time, prevent the development of complications.

This problem is solved by creating based hydrogel nanocomposite wound dressings containing bioactive components: antimicrobial - modified silver-montmorillonite (Ag-MMT) and antioxidant - fullerenol.

The task and the technical (social) result is achieved due to the fact that the bioactive hydrogel wound coating contains a copolymer of acrylic acid and acrylamide, wherein the composition of the copolymer filler included-modifier-modified silver montmorillonite, which allows to obtain hydrogel nanocomposite with intercalated structure having antimicrobial activity, immobilization in a copolymer at the stage of synthesis of fullerenol coating gives the antioxidant action.

Bioactive hydrogel wound covering is characterized in that to obtain a homogeneous structure of the polymer matrix wound dressings and optimal, dosage and prolonged, use of antimicrobial action of finely dispersed fraction of the modified silver montmorillonite particles with a diameter less than 0.25 mm.

Bioactive hydrogel wound coating is characterized by the fact that the concentration of bioactive components in the matrix �leaves, wt.%:

a modified silver-montmorillonite2,0-5,0
fullerenol1.0 to 2.0

It wound coating has a high degree of hydration meets the modern requirements of wound management and provides optimal conditions for earlier activation of reparative processes, minimizing the inflammatory phase plot of damage. This allows for earlier recovery of vital functions of the damaged organ.

Hydrogel wound matrix coatings synthesized by reacting the neutralized acrylic acid (AA) and acrylamide (AA) with N,N'-methylene-bis-acrylamide (MBA) as a crosslinking agent in the presence of redox systems "ammonium persulfate - tetramethylethylenediamine (TMED)". Pre-purified acrylic acid was dissolved in water at a concentration of 30 wt.%. The neutralization was performed by sodium bicarbonate solution (NaHCO3) under the control of the pH-metry. Pre-calculated amount of a solution of NaHCO3was gradually added to establish the pH of the mixture in the range of 7.0 to 7.5. The neutralization reaction is accompanied by release of large amounts of carbon dioxide,�that after its completion the mixture was allowed to stand for 5-10 minutes. Then to the mixture was added the calculated amount of AA, MBA, TMED and water. The mixture was thoroughly stirred until complete dissolution of all components followed by re-control of pH. Thereafter, the mixture was cooled to a temperature of 5-10°C to prevent spontaneous polymerization. After cooling, the mixture is added the calculated amount of ammonium persulfate, was mixed thoroughly and poured in chemically pure form.

Introduction bioactive fillers, an aqueous solution of fullerenol and a modified silver-montmorillonite was carried out at the stage of synthesis of the hydrogel polymer, achieving a uniform disclosure of layered structures and the distribution of montmorillonite in the polymer using an ultrasonic disperser. Thus, the obtained bioactive wound dressings, representing nanocomposites with intercalated structure due to the introduction of chains of acrylamide polymer in magpakita space of montmorillonite particles.

Development and practical application of hydrogel wound dressings are particularly relevant in the light of modern principles of the wound in a moist environment. A high degree of water content of hydrogels helps soften the necrotic formations due to the rehydration of the tissues, which facilitates their mechanical removal. The creation of a moist wound �Reda provides for optimal wound healing conditions and, as a result, accelerates the processes of granulation and epithelization. Hydrogel polymers are plastic and well modeled on the wounds with difficult terrain, have no adhesion even after prolonged exposure to the wound surface and are easily removed without the risk of trauma. Significant sorption capacity of hydrogels provides elimination of the wound of necrotic tissue, microbial cells, excess wound discharge.

It is known that fullerenol along with other water-soluble clusters of fullerene C60(C60/PVP and C60/Tween 80) has demonstrated antioxidant properties at concentrations of 0.01%. The use of an aqueous solution of fullerenol in wound process will contribute to the stabilization of their own antioxidant defense system, inhibit the development of free radical lipid peroxidation, cellular and capillary membranes, preventing damage to cells and tissues, limiting the spread of the inflammatory changes and secondary necrosis of the tissues, and by enhancing the phagocytic activity of macrophages contribute to the enhancement of nonspecific immunity. Parenteral administration of fullerenol not exhibit acute toxicity, does not affect the morphological and functional condition of internal organs, metabolism and don't you�device pathological reactions of the blood.

It is known that silver has a broad spectrum of antibacterial action, also influences the growth of yeast, fungi. Certificate of identification of resistant microorganisms have a silver sporadic, which is especially important on the background of increased resistance to other traditional antiseptic. The most promising for immobilization on wound dressings are nanoscale particles of silver (AgNPs - ArgentumNanoParticles) providing a metered-dose and prolonged antimicrobial effect. Limited the interlayer space of montmorillonite, being specific "nanoreactors", can be used for the cultivation and delivery of nanoscale particles of silver.

Preclinical trials, namely the effect of local application of reticulated bioactive wound dressings, established by experiment on animals (male rats of Wistar line).

Examples of pre-clinical trials

Example 1. Biocompatibility of wound coatings was studied on the model of skin-planar conditionally aseptic wounds in 20 rats. In the postoperative period, clinical signs of inflammatory and degenerative changes in the wound is not marked. According to histomorphological studies on day 7 installed classic uncomplicated picture of the regenerative process, allowing �to conclude biocompatibility and bioinertness wound coverings.

Example 2. To determine the ability of wound dressings to inhibit the growth of bacterial flora on the border of contact with wound surface indicators installed their bacteriostatic action, as well as minimum inhibitory concentration (MIC) of Ag-MMT in their composition.

The MIC values of Ag-MMT in the matrix composition, the wound dressings on the basis DCSH acting on the reference and hospital strains of microorganisms, set at 0.1 wt.% and 0.2 wt.%. respectively.

The test results are shown in table 1 and Fig.1 - P. aeruginosa, Fig.2 - E. coli, Fig.3 - MRSA (concentration of Ag-MMT in the polymer mass.%: 1-1%, 2-2%, 3-3%, 4-5%, 5-10%).

Table 1
Evaluation of bacteriostatic action wound coverings on areas of stunted growth of microorganisms, mm
The Ag-MMT, wt.%
Strains of microorganisms
ReferenceE. coli3,2±1,3a 10.4±3,3230,7±2,0434,3±2,87 36,8±3,11
S. aureus02,4±0,568,6±2,7315,7±2,6427,6±3,15
P. aeruginosa2,2±0,658,3±1,1627,5±3,2231±2,6532,8±2,81
HospitalK. pneumoniae3,6±1,0612,6±1,5518,46±2,320,33±3,4824,1±3,01
P. aeruginosa02,4+1,087,4+1,6515,45±2,5321,3±2,75

Example 3. The evaluation of the ability of RA�developed coating to inhibit the growth of wound microflora found a significant reduction in the level of bacterial contamination of infected wounds, and the possibility of relatively long it is maintained below the critical level (103SOME) due to the prolonged antimicrobial action. Effective suppression of wound infection, which is the leading pathogenetic link of the complicated course of wound process, should help to reduce the duration of wound healing (Fig.4 - bioactive hydrogel wound cover, Fig.5 - aseptic gauze bandage).

Immobilization of Ag-MMT as an antimicrobial component of bioactive wound dressings based hydrogel nanocomposite in a minimum concentration of 2 wt.% allows to obtain a significant bacteriostatic effect in vitro and maintain the level of bacterial contamination of the wound below 103(CFU) for 5-7 days in vivo.

Example 4. According to planimetric studies presented in table 2, it was found that topical application of bioactive hydrogel wound dressings prevents complications during the healing process, allows to reduce the time of wound healing in the treatment of granulating wounds after deep burns and infected skin-planar RAS 15-20%.

Table 2
Indicators planimetric studies �of azulene RAS, %
The experimental group
The observation period
Granulating wounds after deep burnsInfected skin of planar-wound
5 day20,8±1,14,2±0,227,4±0,8*5,5±0,1*29,4±1,4*5,8±0,4*43,4±0,2*8,7±0,3*
10 days42,3±2,14,2±0,163,2±1,3*6,3±0,3*58,2±0,4*5,8±0,6*89,5±2,1* 8,9±0,5*
15 days68,1±1,34,5±0,398,7±0,6*6,6±0,6*95,3±0,3*6,3±0,3*--
20 days99,3±0,34,9±0,2------
The healing periodof 20.0±0,415,8±0,7*16,0±0,413,4±0,3*
Note to table 2:
1 - reduction of the wound area as a percentage of the initial size of the wound;
2 - healing rate (%/day).
* Differences from control are significant at p<0,05.

Bioactive hydrogel wound coating containing at its core with�of OLIMAR acrylic acid and acrylamide, characterized in that at the stage of synthesis in the composition of the copolymer included two components: a modified silver-montmorillonite in the form of finely dispersed fractions with particle diameters of less than 0.25 mm at a concentration of 2.0-5.0 wt.%, allowing you to receive as a polymeric matrix coating the hydrogel nanocomposite intercalated with homogeneous structure, giving the coating is metered and prolonged antimicrobial action; and fullerenol in a concentration of 1.0-2.0 wt.%, gives the coating an antioxidant effect.


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