Medical coverage for closing wounds of various etiologies “OTRAN”

recommendations on application for medical institutions and educational films have been prepared.

At the moment, Medical coverage for the closure of wounds of various etiologies. OTRAN is at the stage of registration in the Russian Federation.

Small-scale production was set up in the amount of up to 50 thousand pieces. per month.

Patents were obtained for polyurethane compositions for coating OTRAN, for the production technology of a number of nanoparticles used for the Project’s products.

Contracts with 2 distributors of medical products.

Идут переговоры с гос. структурами РЖД, МЧС, ВС России и другими ведомствами о закупках «ОтРАН».

Work is underway to further improve the coating and packaging "OTRAN".

Worked out a plan to build mass production. Selected technological equipment.

PKF ORBIT LLC
(Ryazan)

1) Application

2) Patents

4) Sales

3) Production

5) Development

The products have been successfully tested in medical institutions.

of treatment, see Appendix.

the sacrum sore

Abdominal wall burn closure

Heel sore closure

The photos were taken in the resuscitation department of the Research Institute of Emergency Care. N.V. Sklifosofskogo

significant drawbacks:
trauma,
low hydroscopicity
decay in a wound, etc.
Modern dressings and coatings do not have these disadvantages, but not one of the coatings on the market is not “ideal” or universal, because they either have a clear specialization in the type of wounds, or have some kind of deficiency, for example, inconvenience in use (lack of adhesion to wound - the need to use additional fixing bandages

There are a number of requirements for the “perfect dressing” formulated by T. Turner in 1990. : *
To create and control the wound environment moisture optimum for healing;
Provide and control the optimal gas composition of the wound environment;
Maintain an optimal concentration of hydrogen ions (pH) in the wound;
To provide heat insulation of the wound from the external environment;
Be impervious to microorganisms on both sides;
Be non-toxic, do not contain substances or fragments that can interfere with healing;
Be atraumatic without causing pain or damage to the newly formed tissue or epithelium when changing the dressing.

* - such requirements became the basis for the start of work to create a coating

(specialized coatings) in a number of important parameters, as well as the traditional analogue (bandage) in the cost of treatment (see the next. Slide)

* - The results of the research laboratory NAKFF (National Agency for Clinical Pharmacology and Pharmacy)

Comparison of dressings

costs for the salaries of medical personnel.
At the same time, the reduction in the cost of maintaining patients in the hospital, by reducing the treatment time by 1.5–2 times, exceeds all other cost items.

+ 10342руб.

total
saving:

Standard treatment bandage and gauze

Project Products

Comparison of the cost of treatment with traditional coating (bandage)

polymer mixture (Sarov)

Mixing basic chemicals that form the basis of the polyurethane foam composition

Production and addition of nanosized particles on the example of nano-boehmite

One of the main active substances providing a given level of the final characteristics of the product

Mix filling station
(Ryazan)

Filling is carried out in specially designed bags of aluminized polyethylene:

Fill 2 component mixture with nanobaemic in the “reactor package”.

1)

Packaging area
(Ryazan)

Preparation of the product OTRAN for transportation on
warehouse or delivery to the consumer:

moisture control

Preparation of additives in raw materials for component A

Removing excess moisture

Input control

Raw material

Stage 1

Stage 2

Stage 3

Stage 4

Heating, dissolving sediment

Stage 5

Mixing components, obtaining component A

Control

Bottling
Final packaging

Stage 6

Stage 7

Stage 8

Consumer

Схема ключевых технологических этапов производства

commonly used:
    in ultra-fine filters;
    as an antacid ("Almagel")
    as a coating agent, filler, etc.

Nanocrystalline boehmite is currently one of the most sought-after and promising bases for the manufacture of heavy-duty ceramics, leucosapphires, chip substrates, super-bright LEDs, fire retardants, etc.

The choice of nanocrystalline boehmite as an additive is due to the known bioactivity of this substance as a sorbent with full resistance to the ingredients of the polyurethane foam coating.

Antacids (with boehmite additives)

The mechanism of antimicrobial properties, sorption properties

Antimicrobial properties

Physical and mechanical propertiesсвойства

Pore formation

Nanocrystalline boehmite improves the antimicrobial properties of the coating and improves the required physical and mechanical properties *

* Improving the antimicrobial properties of the coating by adding any drugs, antiseptics, etc. to component A or B impossible, since when the chemical composition of the coating components changes, the polymerization reaction does not occur completely, the reaction temperature shifts, pore formation deteriorates, etc.

of the coating "OTRAN"

Study of antimicrobial properties

The sharp edges of the needle particles and plates of the rhombic form of nanocrystals have a direct damaging effect on the bacterial membrane. The possibility of such a direct mechanical effect of nanoscale crystals on E. coli bacteria was first shown by the University of Pittsburgh scientists in 2004

Nanocrystalline boehmite in the composition of the polyurethane foam coating enhances its antimicrobial properties

Mechanism of antimicrobial action

The inner surface of the micropores OTRAN is abundantly covered with needle-shaped nanocrystalline boehmite, whose fractal clusters have the properties of a biologically active sorbent.

highest sorption capacity for biological objects.

Sorption

coating with nanocrystalline boehmite
  coating without nanocrystalline boehmite
  medical bandage of two-layer polyurethane “Syspur-derm”
Purpose of the test
Qualitative comparison of antimicrobial properties of coating samples
Test conditions
Test conditions - polyurethane foam coatings on the surface of the nutrient medium contaminated with bacterial pathogens of wound infection
Studies were conducted under sterile conditions of class 2 microbiological protection box.
Test results

Conclusion
Coating with nano-boehmite has the best antimicrobial properties

+ - слабый рост, ++ - подавленный рост, +++ - умеренный рост, ++++ - интенсивный рост

Antimicrobial properties (1)

the test
Qualitative and quantitative determination of the antimicrobial action of a coating with nanocrystalline boehmite
Test conditions
The antimicrobial effect of coating with nanocrystalline boehmite is investigated by determining the number of microflora per 1 cm according to the methods of Е.А. Fedorova and co-authors.
19-hour cultures of standard museum strains Stephylococcus aureus 6538 and Pseudomonas aeruginosa ATCC 25923, recommended by the standards of the international CLSI standard for the study of antimicrobial properties, were used as test cultures.
Conclusion:
After 24 hours, the microbial flora under the coating with nanocrystalline boehmite was not detected

Antimicrobial properties (2)

improves the demanded physical and mechanical properties.

Purpose: conducting physical and mechanical testing of coatings with nanocrystalline boehmite
Samples: 5 samples of coating, approximately 250 * 250 * 60 mm in size (three coatings without boehmite and two coatings with boehmite)
Test methods: work was carried out to determine the following physicomechanical indicators — compressive stress at 40% strain, relative elongation and breaking stress under tension, tear strength, apparent density, relative residual strain.
Used equipment: machine for compressing and stretching materials, die-cutting press, cutting machine / band saw, scales (0.001 and 0.0001), caliper, micrometer, thickness gauge.

Sample to determine the strength of tear

The study of physical and mechanical properties

Physical and mechanical properties

antimicrobial effect, but also contributes to a more uniform pore formation * in the bulk of the material.

Microscopic data on coatings with nanocrystalline boehmite (C) and without adding (A and B) (approximation factor 200)

А

Б

В

Pore formation

* - for this characteristic, “nanoscale” of boehmite is not as significant as for previous

in 2018 was more than 350 million packs or about $ 150 million in distributor prices.
The market volume was estimated based on data from Pharmexpert, as well as data from Veropharm.
The division of consumption of dressing materials by sales channels is given in physical terms. The calculation was made on the basis of data from various sources, including data on the procurement of dressing materials by hospitals, as well as taking into account international comparisons.
The Russian market of dressings is characterized by the predominance of traditional means over modern ones, which determines the high potential for distribution and sales growth of OTRAN in Russia.

(2018)
total 181 million packs

88%

9%

Medical institutions

Pharmacies

(2%) Military hospitals

(<1%) other

83%

17%

Medical institutions

Pharmacies

54%

Medical institutions

Pharmacies

44%

Consumption of bandages and gauze by consumer categories

Consumption of adhesive plasters by consumer category

(>1%) other

(>1%) Military hospitals

(2018)
total 101 million packs

(2018)
total 13 million packs

Consumption of modern dressing equipment
by consumer category

(>1%) other

(~1%) Military hospitals

* - the data on the world and Russian market will be specified as part of a detailed marketing research

foam coating "SAREL", 2002 was carried out in 3 leading research institutions of the country:
Institute of Surgery them. A.V. Vishnevsky
Institute of Emergency Medical Care. N.V. Sklifosovsky
Moscow Medical Academy. THEM. Sechenov.

The main proven properties of the product:
Excellent water and bio-insulation properties;
Excellent sorption properties;
No adhesion to wet surfaces with good adhesion to dry surfaces;
Non-toxicity, self-sterilization when mixing components;
Absolute repetition of the relief of the wound surface;
Improved capillary blood flow in the affected area.

When studying the scope of application of the coating, it was found that “OTRAN”:
optimizes the course of the wound process in patients with:
trophic ulcers
long-term non-healing, burn, gunshot wounds
and also actively affects the wound process in patients with diabetes mellitus complicated by diabetic foot syndrome

The use of the product of the project allows to reduce the time of treatment of patients by 2-3 times
There are no direct contraindications to the use of the coating, with the exception of rare cases of abundant suppuration, anaerobic and sinus infection

Test results

The influence of OTRAN on the healing process of burn wounds;
  The effect of OTRAN on the healing of nonhealing wounds, trophic ulcers, and other injuries of the skin.

2

3

4

5

6

7

и пола:

The distribution of patients by burn area:

The high efficacy of the project product has been proven in treating patients with superficial burns, which heal under it, with burns of grade II - for 3 days, with burns of grade II - 7 days earlier than in control groups.

The results of experimental clinical studies

Source: Source: Thesis Kuranov A.A. "Development and experimental clinical rationale for the use of
polyurethane foam dressings in surgery

The effect of dressings on the healing process of burn wounds

Sample description

Test results:

number of microflora per 1 cm 2
From the data presented in the table, the effect of restraining the colonization of microbes on the surface of burn wounds is clearly revealed with a decrease by 2-3 times the amount of infection per unit area of wounds.
Dynamics of changes in the number of microflora per 1 cm2 of the surface of burn wounds under the coating

Also, studies have shown that the body's immune system, burned, treated with a coating, does not undergo any pathological changes, the occurrence of which could be associated with the effect of the coating on homeostasis.
On the contrary, during the treatment with the help of the coating, the phenomenon of stimulation of neutrophilic phagocytosis was noted in patients, which should be regarded as a positive phenomenon that helps patients to better cope with the microbial flora remaining on the burn wounds under the coating.

Source: Thesis Kuranov A.A. "Development and experimental and clinical rationale for the use of polyurethane foam dressings in surgery

The results of experimental clinical studies

wounds;
Bedsores
Benefits
Well absorbs exudate;
Well evacuates exudate from the wound;
disadvantages
Not able to occupy wounds of arbitrary shape;
The wound lasts no more than 4 days;
Intended for treatment:
Burns;
Postoperative wounds;
Bedsores;
Benefits
Well absorbs exudate;
Well evacuates exudate from the wound;
disadvantages
Not able to occupy wounds of arbitrary shape;

Lyofoam dressing

Biatain foam dressing

low to medium wound exudate;
Ulcers;
Bedsores;
Diabetic foot;
Superficial burns;
Benefits
Well absorbs exudate
Protects against moisture penetration
disadvantages
Not able to occupy wounds of arbitrary shape.
Not suitable for wounds with copious exudate
Intended for treatment:
Granulating wounds;
Burns;
Ulcers;
Benefits
Impervious to exudate and HIV;
It provokes the rehydration of necrotic tissue;
disadvantages
Not able to occupy wounds of arbitrary shape;

Hydrocolloid dressing
Cutinova

Hydrocolloid dressing
Granuflex

small to abundant;
Burns;
Bedsores;
Ulcers and diabetic foot;
Benefits
Well absorbs exudate;
Protects against moisture penetration;
Maintains optimum moisture;
disadvantages
Not able to occupy wounds of arbitrary shape;
Does not prevent from repeated mechanical damage;
Intended for treatment:
Ran with low exudate content;
Dry wounds;
Burns;
Benefits
It provokes the death of necrotic tissue;
Maintains optimum moisture;
Able to occupy wounds of arbitrary shape;
disadvantages
Does not prevent from repeated mechanical damage;
Not suitable for wounds with medium and abundant exudate content;

Hydrofiber dressing
Allevyn

Hydrogel dressing
Hydrosorb

moisture penetration;
Maintains optimum moisture;
disadvantages
Not able to occupy wounds of arbitrary shape;
Does not prevent from repeated mechanical damage;
Intended for treatment:
Run with any exudate content;
Burns;
Benefits
Absorbs and holds any amount of wound exudate;
disadvantages
Does not prevent from repeated mechanical damage;
Not able to occupy wounds of arbitrary shape;

Absorbent dressing
Mepitel

Absorbent dressing
Mesorb

Main competitive products