RU2228203C2 - Wound-healing material - Google Patents

Abstract

FIELD: wound-healing materials. SUBSTANCE: invention in particular relates to wound coverings and can be used in local healing of wounds such as skin injuries without abundant bleeding including thermal injuries (burns, frostbites), trophic ulcers with different etiology as well as microcirculations of soft tissues caused by disorders of local homeostasis, e.g. bedsores. Material is based on fluoroplastic-type hydrophobic porous polymer material supported by nonwoven materials. EFFECT: prevented contamination and secondary infection when treating partially healed seam-closed wounds and enabled protection against mechanical damages. 7 cl, 5 ex

Description

The invention relates to medicine, namely to wound coverings, and can be used in the local treatment of wounds, such as skin lesions without profuse bleeding, including thermal (burns, frostbite), trophic ulcers of various etiologies, and also caused by a violation of local homeostasis, microcirculation of soft tissues, such as pressure sores.

Currently, there are many new biologically active dressings, such as draining sorbents, gel dressings, synthetic non-woven materials, etc. Their action is aimed at the wound process, depending on its phase and flow characteristics. All of them are differentially successfully used to treat wounds. However, it should be noted that even with an active sorption mechanism, the listed materials are ineffective in the treatment of necrotic wounds caused by impaired blood microcirculation.

The closest dressing in its mechanism of action is a perforated film based on polyvinyl alcohol. It does not delay the evaporation of moisture and does not prevent drying of the wound surface (Pakhomov SP “Surgery of burns in children” Nizhny Novgorod Research Institute of Traumatology and Orthopedics. Magazine “Path to success”. M: 1997, p.119-121).

The disadvantage of using a perforated film based on polyvinyl alcohol is the appearance of a secondary infection due to the presence of large pores that do not impede the access of microflora to the wound surface.

The aim of the present invention is to eliminate the occurrence of a secondary infection, reduce the healing time of wounds, as well as reduce the labor costs of medical personnel, the consumption of medicines and dressings.

This goal is achieved by using a hydrophobic composite material as a wound cover, which is a porous polymer film material made of F-42L fluoroplast on a substrate of non-woven materials (for example, polypropylene, lavsan) with a pore size of 0.15 to 0.6 micrometers and a total porosity up to 85% (TU 6-55-221-1182-91 with amendment 1-2, STP 221-41-91 with amendment 1).

The two-layer material with a hydrophobic coating of fluoroplastic is practically not wetted. The material has high structural strength - not less than 5.5-6.3% in the direction along the material and 6.3-6.5% in the direction across the material, which practically does not change even in the wet state. The material has a flat, smooth surface; visually, two-layer structure is not observed.

The material acts as an artificial epidermis, easy to use in hospital, outpatient and home conditions. It is applied to the affected area of the skin and fixed around the perimeter in any known manner, for example using gluol, glue BF-6, BF-2, patch, bandage, etc. The material may additionally have an adhesive layer for improved adherence to the wound surface. On top of the material without removing it from the wound, biologically active agents in the form of solutions can be applied, which help to clean the outer surface of the coating from dried exudate.

This artificial epidermis does not cause allergic reactions, has a very high vapor permeability value of 11.6 mg / cm ² · hour, and is easily and painlessly removed from the wound by treating it with distilled water or physiological saline.

The proposed material can serve as the first layer adjacent to the wound, a multilayer sorption napkin or pillow, which in turn can be moistened with a drug or contain an immobilized antibiotic and / or anesthetic. The combination of this material with an absorbing layer makes it possible not only to distribute exudate over the area, but also to divert it from the wound, keeping it in the depth of the suction material. This modification of the dressing is permeable to air and moisture.

To study the effectiveness of this material in the treatment of skin lesions, three groups of patients were presented. The first group included patients with trophic ulcers - 7 people, the second group included patients with pressure sores in diameter from 3 to 5 cm, - 5 people, the third group included patients with burns I and II degree - 5 people.

Example 1. Patient K., 47 years old, as a result of a household injury, received a burn of the inner thigh area of about 25 square meters. see I-II degrees of severity. After the initial surgical treatment, an artificial epidermis of porous polymer material based on F-42L fluoroplast on a substrate of nonwoven polypropylene material with a pore size of 0.45 micrometers was applied to the burn surface. The material protruded 2-3 cm beyond the wound edges, and BF-6 glue was applied to the edges of the coating. Control examination and dressings were performed on an outpatient basis once every 3 days. Against the background of the treatment, rapid epithelization of the burn surface without scar formation was noted. It was noted that dressings, some of which the patient himself performed by wetting the material with a weak solution of potassium permanganate, were not accompanied by pain.

EXAMPLE 2. Patient R. 56 years old had a trophic ulcer of the right leg, which was closed by the claimed material with a pore size of 0.6 micrometers and fixed adhesive plaster. As a result, rapid epithelization of the damaged surface without scar formation was noted. The film easily departed and its change was not accompanied by damage to the neoepithelium. Despite the high degree of patient sensitization to other wound dressings and ointments, reactions to this film were not noted.

EXAMPLE 3. A patient - a man of 65 years old, suffered from diabetes mellitus, diabetic angio-and polyneuropathy. As a result, against the background of chronic venous insufficiency, an extensive mixed (venous and diabetic) trophic ulcer with a size of 2.0 × 3.5 cm and a depth of 1 cm formed on the lower leg. Dressing with conventional wound coverings caused a pronounced pain syndrome. A coating of the claimed material was applied. An easy modeling of the ulcer defect profile was noted. Repeated dressings were not accompanied by pain, and their patient could perform independently. Restoration of the skin was noted.

EXAMPLE 4. A 65-year-old patient, as a result of loss of mobility, had pressure sores of up to 10 cm in size. An adhesive plaster coating was fixed in these areas. At the same time, it was possible to reduce the recovery time of blood microcirculation in damaged areas of soft tissues, and to stimulate cell activity.

EXAMPLE 5. A 30-year-old patient was admitted with a 3.8 cm wound from which blood oozed. A multilayer dressing was applied to the patient. The first layer contains the claimed material with pore sizes of 0.25 micrometers, the second layer contains sorbent material, the surface layer contains the claimed material with pore sizes of 0.6 micrometers. The bandage was fixed with a bandage. Control examination and dressings were performed on an outpatient basis once every 2 days. Against the background of the treatment, rapid epithelization of the wound surface without scar formation was noted. It was noted that dressings, some of which the patient himself can perform by wetting the material with a weak saline solution, were not accompanied by pain.

The gas permeability of this material supports the possibility of gas exchange of oxygen and carbon dioxide, as well as humidity circulation. With insufficient gas exchange, the pH in the wound changes and determines the concentration of oxygen, which stimulates the epithelization of the wound. Permeability also maintains a balanced level of moisture in the wound environment.

This material does not cause any mechanical or chemical irritation. The coating is used as a first aid to prevent contamination and as a shield against secondary infection, in the treatment of healing by primary intention, closed by a suture of wounds and from mechanical damage.

Claims (7)

1. Wound healing material, including a hydrophobic porous polymeric material of ftoroplast F-42L on a substrate of nonwoven materials. 2. The wound healing material according to claim 1, in which the pore size is from 0.15 to 0.6 microns. 3. Wound healing material according to paragraphs. 1 and 2, which further comprises an adhesive layer located on the abutment side of the wound surface. 4. Wound healing material according to claims 1 to 3, which further comprises an sorbent layer. 5. Wound healing material according to claims 1, 2 and 4, in which the material according to claim 1 is the first layer adjacent to the skin. 6. The wound healing material according to claim 4, in which the sorbent layer contains an anesthetic or antimicrobial drug. 7. The wound healing material according to claim 4, in which the sorbent layer contains a proteolytic enzyme.