RU2692566C1 - Method of vacuum drainage of sternotomy wounds - Google Patents

Abstract

FIELD: medicine.SUBSTANCE: invention refers to medicine, particularly to thoracic surgery, and can be used in treating poststernotomous mediastinitis (PSM). Method of vacuum drainage of sternotomy wounds involves wound dressing of elastic porous material, wound coating and adjoining area with insulating film, communication of bandage with drain line through collecting container with vacuumizing device. Drain line end is placed in the bandage volume and perforated, wherein the insulating film is tightly fixed outside the contact with the wound surface on the perimeter of the insulating film. Vacuum is maintained in alternating mode either at -50 mm Hg, or at -150 to -200 mm Hg, wherein duration of one level of evacuation is 2–5 minutes, after which level of vacuum is changed to second level, and is also maintained for 2–5 minutes, then all are repeated, and evacuation is performed continuously for 12 hours daily and after 12-hour pause is resumed, in addition, evacuation with one dressing is carried out for 3–5 days, after which the dressing is replaced with a new one, and then all are repeated. Total length of treatment is 25–30 days.EFFECT: technical result, manifested when solving the proposed technical problem, is expressed in accelerating regenerative processes in the wound surface area.1 cl, 34 dwg

Description

The invention relates to medicine, in particular to thoracic surgery, and can be used in the treatment of poststernotomic mediastinitis (PSM).

There is a method of vacuum therapy of wounds, including the placement of a wound dressing in a wound containing polyurethane foam with open pores, airtight closing of the wound area with a coating material, with the possibility of connecting a vacuum source and the impact on the wound and the skin surrounding it with a vacuum (see WO No. 1993/009727, 1993).

Conventional foam dressings are compressed with varying strengths depending on the applied vacuum. Because of this, there may be a narrowing of the channels necessary for removal of wound exudate and a decrease in the effectiveness of removal of exudate. In addition, foam sticking to the bottom of the wound can occur. The newly formed tissue can grow into the foam. This problem is a well-known complication of vacuum wound therapy (FDA complaint data base - a database of complaints from the US Food and Drug Administration). To solve this problem, additional layers in contact with the wound, for example a film, are often introduced between the foam and the wound bottom (see, for example, WO 2001/85248, 2001). However, these additional layers of contact with the wound impair the passage of exudate. In addition, the adhering foam must be removed when the dressing is replaced, which requires great effort, for example, by washing with Ringer's solution. A tissue that has grown into a foam can, when the dressing is replaced, lead to injury to the tissue and, consequently, to impaired wound healing.

In addition, when using conventional wound dressings, foam particles can enter the wound. They can lead to irritation of the wound and to its slow healing. This problem will further intensify if the wound dressing is cut to the size of the wound before use, since then, in particular, unbound foam particles are formed at the edges of the incision.

There is also known a method of vacuum drainage of sternotomic wounds, including placement of a bandage made of elastic porous material in a wound, covering the wound and the adjacent area with an insulating film, posting a dressing, a drainage line, through a collection container with a vacuum means (see RU No. 2545787, IPC A61L 15 / 26, A61L 15/42, A61F 13/02, A61M 1/00, 2015).

The disadvantage of this solution is a rather long duration of the reparative regeneration process.

The objective of the invention: increasing the speed of reparative regeneration.

The technical result, which is manifested in solving the stated technical problem, is expressed in the acceleration of regenerative processes in the area of the wound surface.

To solve the stated technical problem, the method of vacuum drainage of sternotomic wounds, including placing a wound of elastic porous material in the wound, covering the wound and the area adjacent to it with an insulating film, posting a dressing, a drainage line, through a collection container with a vacuum means, in that the end is drainage the lines are placed in the dressing volume and are perforated; in this case, the insulating film is hermetically fixed out of contact with the wound surface, on the perimeter of the insulating film, e, the vacuum is maintained in an alternating mode, or at the level of -50 mm Hg. Art. or at the level of -150 to -200 mm Hg. at that, the duration of one vacuum level is 2-5 minutes, after which the vacuum level is changed to the second one, called, and it is also maintained for 2-5 minutes, then everything is repeated, and vacuuming is carried out continuously for 12 hours daily, and after a 12-hour break, resume, in addition, the evacuation using a single dressing is carried out for 3-5 days, after which the bandage is replaced with a new one and then everything is repeated, and the total duration of the treatment process is 25-30 days.

Comparative analysis of the signs of the claimed solution with the signs of the prototype and analogs indicates the compliance of the stated solution to the criterion of "novelty."

The combination of features of the claims of the invention provides an accelerated formation of the regenerate, while the features of the distinctive part of the claims solve the following functional tasks.

The sign "... the end of the drainage line, placed in the volume of the dressing and perform perforated ..." ensures that the exudate enters the drainage line.

The sign "... the insulating film is tightly fixed out of contact with the wound surface, on the perimeter of the insulating film ..." excludes irritation of the wound surface and air leaks from the environment, and not from the wound.

The sign "... the vacuum is maintained in a variable mode ..." contributes to minimizing hyperemia and edema in all groups of patients with various pathologies at the first stage of healing.

Signs indicating that the vacuum is maintained “either, at the level of -50 mm Hg. Art. or at the level of -150 to -200 mm Hg. at the same time, the duration of one vacuum level is 2-5 minutes, after which the vacuum level is changed to the second one, and it is also maintained for 2-5 minutes, then everyone repeats "they set the most effective operating characteristics of the vacuum process.

The signs "... vacuuming is carried out continuously for 12 hours daily, and after a 12 hour break, they resume ..." exclude the influence of circadian circadian rhythms.

The signs "... evacuation using one dressing is carried out for 3-5 days, after which the dressing is replaced with a new one and then everything is repeated ..." set the duration of use of the dressing.

The sign "... the total duration of the treatment process is 25-30 days ..." sets the total duration of the treatment process.

The claimed method is illustrated by microphotographs of the biopsy specimen (stained with hematoxylin and eosin, magnification x200, except for Fig.9 where magnification x400). Figure 1-figure 5 shows the biopsy specimens of postoperative wounds, obtained at the time of surgical manipulation (a patient with normal body weight and without diabetes); figure 6-figure 9 shows the surface leukocyte-necrotic layer; leukocyte infiltration in a wound on a preparation from the biopsy of the wound surface area of patients with type 2 diabetes mellitus, after treatment: FIG. 6 - by open reference; Fig.7 - with the use of variable vacuum drainage; Fig.8 and 9 - with the use of permanent vacuum drainage; 10 and 11 show the vascular layer of granulations, leukocyte infiltration beyond the vessel in a wound on a preparation from a biopsy of the wound-surface area of a patient suffering from type 2 diabetes after treatment with alternating vacuum drainage: figure 10 shows hyperemic vessels; 11 shows tissue infiltration; Fig. 12-Fig. 14 show blood vessels on a preparation from a biopsy of a patient's wound surface area without overweight and diabetes mellitus on day 4 after the diagnosis of PSM and surgical debridement of a post-sterno wound after treatment: Fig. 12 - by the open type method; Fig.13 - alternating vacuum drainage method; Fig.14 - by the method of continuous vacuum drainage; 15–21 show blood vessels on a preparation from the biopsy of the patient’s wound surface area, after treatment: FIG. 15 - by open reference; Fig.16-20 - with the use of variable vacuum drainage; Fig.21 - with the use of permanent vacuum drainage; on fig.22-24 blood vessels are shown on the preparation from the biopsy of the wound surface area of a patient with chronic renal failure, after treatment: fig.22 - by open reference method; Fig - using alternating vacuum drainage; Fig.24 - with the use of permanent vacuum drainage; Figs 25-30 show preparations from the biopsy of the wound-surface area of patients with chronic renal failure, 25 days after the diagnosis of PSM from the group: Fig. 25 is an open management method; Fig-28 - variable vacuum drainage; Fig.29-30 - permanent vacuum drainage; on Fig-33 shows the formation of connective tissue scar in patients with obesity on the 45th day of treatment with the use of: Fig - alternate vacuum drainage; Fig and 33 - permanent vacuum drainage; in fig. 34 schematically shows a list of elements ensuring the implementation of the method (side view).

The drawings show 1 - wound environs (i.e., as a rule, intact skin), 2 - air-tight covering material, 3 - wound dressing (polyurethane foam with open pores), 4 - vacuum fitting (port), 5 - drainage line ( connection line with vacuum source), 6 - team tank (collection of exudate), 7 - vacuum installation, 8 - bottom of the wound.

Thus, the system of elements comprises an airtight coating material 2, means 4-5 for the functional connection of the wound area with the outside of the coating material installation 7, and also the wound dressing 3 (foam with open pores). The covering material 2 is secured in the vicinity of the wound 1 containing intact skin. The size of the covering material 2 is calculated so that the covering material can be fixed outside the wound area in the vicinity of the wound 1. The covering material 2 can be present in various sizes and shapes, for example, be round, oval or rectangular. It may also have an irregular shape corresponding to the shape of the wound. The covering material 2 is usually fixed in the vicinity of the wound 1 and is air-insulated. This can be done, for example, by making the covering material 2 with a sticky edge. Also, the adhesive may be applied either on the edge of the covering material 2 and / or on intact skin in the vicinity of the wound 1. This has the advantage that it is easier to fit the covering material to the shape and size of the wound. In the embodiment shown, the vacuum fitting 4 is installed on the outer side of the airtight coating material 2 opposite to the wound. In order to functionally connect the wound area to the outside of the covering material by the vacuum unit 7, in the area of the vacuum fitting 4 in the covering material 2 there must be a through hole (in the drawings shown), at the same time, the vicinity of the hole is sealed to the side of the fitting 4 facing it.

In addition, the end of the drainage line 5, located in the volume of the wound dressing 3 is made in a perforated manner. Team tank 6 (collection of exudate) 6 is located between the fitting 4 and the installation of the vacuum 7.

The claimed method of vacuum drainage of sternotomic wounds includes placement in a wound, in contact with its bottom 8, wound dressing 3 of elastic porous material (polyurethane foam with open pores), placing in the volume of dressing end of the drainage line 5, made by the perforated method, and subsequent placement on the wound and the adjacent area of the airtight coating material 2 of the air insulating film, which is sealed in the vicinity of the wound 1, on intact skin. Next, report the wound dressing 3, with a drainage line 5 through a vacuum fitting 4, and then through the collection tank 6 (collection of exudate) with the installation of a vacuum 7.

The insulating film is hermetically fixed out of contact with the wound surface, on the perimeter of the insulating film.

The vacuum is maintained in a variable mode, or, at the level of -50 mm Hg. Art. or at the level of -150 to -200 mm Hg. at that, the duration of maintaining one level of vacuuming is 2-5 minutes, after which the vacuum level is changed to the second one, called, and it is also maintained for 2-5 minutes, then everything is repeated, and vacuuming is carried out continuously for 12 hours daily, and after a 12 hour break, resume. Vacuuming using one wound dressing 3 is carried out for 3-5 days, after which the dressing is replaced with a new one and then everything is repeated. Wound sanitation during bandaging was performed using the following solutions: “Chlorhexidine 0.05%”, hydrogen peroxide 3%, “Betadine-iodine 10%”. Usually, the dressing is changed without significant pain, however, in the event of severe pain, the patient was given a local injection of Novocain 0.25% solution into the wound area, before removing the contents. An alternative was the introduction of warm saline into the wound before the contents were removed. The total duration of the treatment process is 25-30 days. This is the time before wound cleansing and active growth of granulations, which makes it possible to impose secondary stitches.

Vacuum dressing is applied simultaneously with the dilution of the wound when an infectious complication is detected.

In all patients, after removal of the sutures from the post-motone wound, at the beginning, her surgical rehabilitation was performed under sterile conditions. Next, the wound is filled with a wound dressing 3 (polyurethane sponge), corresponding to it in shape and size, with a suction catheter perforated along this length pre-installed in its volume (preferably in the axial part), in which form the end of the drainage line 5 is made. the surrounding skin and wound dressing 3 was superimposed with an airtight covering material 2, without direct contact with the wound surface.

The claimed method has been tested, during which the task of assessing clinical and morphological parameters and induction of regenerative processes in the postoperative wound in cardiac surgical patients using the open method of treatment, the effects of variable and constant vacuum was solved.

Examination and treatment of patients was carried out on the basis of 4 centers that provide cardiac surgery to the population of the Russian Federation: Center for Cardiac and Vascular Surgery of the FEFU Medical Center, Vladivostok; Department of Cardiac Surgery PKKB №1 Vladivostok; Federal Center for Cardiovascular Surgery of the Ministry of Health of the Russian Federation, Khabarovsk; NTSSSH them. Bakulev MZRF.

Group 1 (13 people) were patients using variable vacuum drainage in the postoperative treatment, group 2 (14 people) using permanent vacuum drainage in the postoperative treatment, group 3 (30 people) using the open reference method in the postoperative treatment. The study was conducted in accordance with the requirements of the Ministry of Healthcare of the Russian Federation No. 82 dated April 29, 1994 and according to the nomenclature of clinical laboratory research of the Ministry of Health of the Russian Federation (order No. 64 of February 21, 2000) taking into account the provisions of the Helsinki Declaration (2013). Based on prospective, controlled comparative studies, monitoring of morphological changes in the conditions of regeneration of an infected sternotomy wound was conducted in accordance with the principles of evidence-based medicine. Clinical and classical morphological research methods were used in monitoring reparative processes in patients with postoperative sternomediastinitis (PSM), followed by statistical analysis of the data obtained. The study was conducted with the permission of the Ethics Committee of FSBEI HE TSMU and FSAUA HE FEFU.

To solve questions about the possible mechanisms of reparative regeneration under the conditions of an open method of treatment, using constant and variable vacuum using morphological methods of research, we obtained an objective assessment of regeneration in damaged tissues. For a comparative assessment, tissue sampling for research was performed on the day of PSM detection and every 4 days after detection and initiation of PSM treatment, during the surgical rehabilitation of post-motone wounds, according to indications, no more than 1 mm ³ in tissue volume.

From biopsy specimens taken during surgical procedures, further sections were made to study the original tissue by classical morphological methods with further staining with hematoxylin and eosin. The preparations were characterized by a high content of adipose tissue and blood vessels with layers of loose fibrous connective tissue (see Fig. 1-5).

Biopsy samples were taken from the wound surface area taken from patients with type 2 diabetes mellitus after treatment: an open wound management method (see Fig. 6), using permanent vacuum drainage (see Fig. 8 and 9), and using alternating vacuum drainage (see FIG. 7).

A distinctive feature of the initial stage of healing (see FIGS. 10 and 11) using the variable vacuum method is the connection of the wound edges with a granulation tissue, rather than a scar. The inflammatory reaction replacing edema melts dead tissues and cleans the wound, and as it completes, granulations begin to develop, gradually filling the defect that has arisen.

Analysis of microscopic preparations showed that the smallest hyperemia and edema in all groups of patients with various pathologies at the first stage of healing is observed during treatment with variable vacuum therapy (see Figs 12-14).

Granulation tissue has a different appearance depending on the stage of its development. Normal tissue initially has the appearance of a soft-grained fabric, covered with an unclear, gray-greenish bloom, juicy, rich in thin-walled vessels, which makes it bleed easily. In later periods, the granulation becomes paler, denser, the grain disappears, turning into a whitish dense scar.

Granulation tissue consists of six layers that gradually merge into each other: the superficial leukocyte-necrotic layer; superficial layer of vascular loops; a layer of vertical vessels; ripening layer; a layer of horizontally arranged fibroblasts; fibrous layer.

In observations of patients with an open method of treatment, it was found that granulation tissue appears on the borders between the edges of the wound on the 4th day. It consists of many granules, which are closely pressed to each other. They include: amphorae substances, looped vascular capillaries, histiocytes, fibroblasts, polyblasts, lymphocytes, multinuclear vagus cells, argyrophilic fibers and segmented leukocytes, collagen fibers. In the group of patients using alternating vacuum drainage, the earlier appearance of granulations was revealed: after two days, pink-red nodules can be seen on the areas free from blood clots and necrotic tissue, the size of the millet grain. On the third day, the number of granules increases significantly and already on the 4th-5th day, the surface of the wound is covered with young granulation tissue. Healthy strong granulations of pinkish-red color do not bleed, have a uniform granular appearance, a very dense texture, emit a small amount of purulent turbid exudate. It contains a large number of dead cellular elements of the local tissue, purulent bodies, admixtures of erythrocytes, segmented leukocytes, one or another microflora with products of their own vital activity. The cells of the reticuloendothelial system, white blood cells, migrate to this exudate, and vascular capillaries and fibroblasts grow into it. The preparations identify granulation tissue, represented by a large number of small full-blooded blood vessels (capillaries, arterioles), between which there are numerous proliferating cellular elements represented by histiocytes, lymphocytes, plasma cells, epithelioid cells and fibroblasts. In all cases, more active angiogenesis is noted when using variable vacuum drainage (see Figs 15-21).

When exposed to the wound surface of alternating vacuum drainage, earlier maturation of granulation tissue, reduction in the number of blood vessels, filling of the wound surface with maturing connective tissue and earlier epithelization of the wound surface are noted (see Fig.16-20).

During the second period of reparation, young granulation tissue located between the edges of the wound, quickly matures, accompanied by the active formation of collagen. This leads to a decrease in the number of vessels and cellular elements, on the one hand, and an increase in the number of collagen and elastic fibers, on the other (see Fig. 22-24).

The third stage of reparation is characterized by active growth of connective tissue with the formation of a strong scar. During this period, the number of fibrous structures in the rumen increases significantly, and their bundles acquire a certain orientation in accordance with the dominant direction of the load. Accordingly, the number of cellular elements and vessels is significantly reduced (see Fig. 25-30).

The restructuring of the scar tissue with an increase in the longitudinal orientation of the fibers is accompanied by a decrease in the number of cellular elements and the preservation of individual small vessels. The greatest number of fibers with the correct orientation in the scar tissue was found in groups using vacuum drainage (see Fig. 31-33).

Thus, histological methods of research allowed to establish that variable vacuum drainage improves the course of the wound process by: reducing local edema; increased local tissue perfusion; reducing the level of microbial contamination of the wound; targeted deformation of the wound bed and a decrease in the volume of the wound cavity; a decrease in the degree of wound exudation; maintaining the optimum moisture content of the wound environment necessary for normal wound healing.

Analysis of the results of clinical and morphological observations showed that in groups of patients with type 2 diabetes mellitus with an open method of administration and with the use of permanent vacuum drainage (as compared with variable vacuum drainage): the edema and infiltration of the tissue surrounding the wound take longer; the maturation of granulation tissue, accompanied by the growth of capillaries and arterioles in the granulations, is much slower, as is further desolation of the vessels with a decrease in the cellular elements of the connective tissue and migrants from the bloodstream.

The use of vacuum drainage in an alternating mode induces regenerative processes in the area of the wound surface to a greater extent, in comparison with the constant vacuum drainage groups and the open method of management, and allows you to achieve an increase in the number of fibers in the scar tissue and their correct orientation in accordance with the dominant load direction in early terms.

The advantage of the influence of vacuum drainage on the wound process, in comparison with the open method of management, is a more pronounced growth stimulation and improvement in the quality of granulation tissue. Due to the fact that the vacuum dressing, by directional deformation of the tissue, reduces the size of the wound surface to the size of the wound, additional mobilization of local tissues before the secondary closure of the wound may not be necessary. The imposition of vacuum drainage on the wound allows you to remove excess wound exudate, stimulates angiogenesis.

Examples of the method.

1. Patient B., 64 years old, was hospitalized at the Department of Cardiac Surgery, Thoracic and Vascular Surgery of the FEFU Medical Center from 03/17/2016 to 04/28/2016 with a diagnosis of Postoperative Sternomediastinitis. The failure of the seams of the sternum.

From the anamnesis: 10.03.2016, the patient underwent coronary artery bypass surgery (ICS-2, AKSH-1) for coronary heart disease. The postoperative period was complicated by the development of sternomediastinitis and instability of the sternum.

Due to the presence of an acute purulent process, a two-stage treatment approach was chosen. The first stage on 03/17/2016, the patient underwent an operation - surgical debridement of a post-steroidal wound with necrectomy and removal of the wire sutures of the sternum. From the same day (03/17/2016) - vacuum therapy in alternating mode was started (includes cyclic switching between two optimal pressure limits, with a certain interval - every 2-5 minutes) with negative pressure levels of -50 mm Hg. Art. (min) and -150 mm Hg. Art. (max). For every 3-4 days, the wound was rehabilitated and the vacuum dressing was changed.

After the relief of acute inflammation and the production of stable (3-fold) negative bacterial cultures on April 20, 2016, secondary sutures were applied to the wound. The postoperative period was uneventful. The wound healed by secondary intention. The patient was discharged in satisfactory condition.

2. Patient P., 61, was hospitalized at the Department of Cardiac, Thoracic and Vascular Surgery of the FEFU Medical Center from 11/21/2016 until 01/20/2017 with a diagnosis of Postoperative Sternomediastinitis. The failure of the seams of the sternum.

From the anamnesis: 11/05/2016, the patient underwent coronary artery bypass surgery (MCS-1, CABG-2) for coronary heart disease. The postoperative period was complicated by the development of sternomediastinitis and instability of the sternum.

Due to the presence of an acute purulent process, a two-stage treatment approach was chosen. The first stage on November 21, 2016, the patient underwent an operation — surgical debridement of a post-steroidal wound with necrectomy and removal of the wire sutures of the sternum. From the same day (11/21/2016) - vacuum therapy in alternating mode was started (includes cyclic switching between two optimal pressure limits, with a certain interval - every 2-5 minutes) with negative pressure levels of -50 mm Hg. Art. (min) and -175 mm Hg. Art. (max). For every 3-4 days, the wound was rehabilitated and the vacuum dressing was changed.

After stopping acute inflammation and obtaining stable (3-fold) negative bacterial cultures on January 10, 2017, secondary sutures were applied to the wound. The postoperative period was uneventful. The wound healed by secondary intention. The patient was discharged in satisfactory condition.

3. Patient Ch., 65 years old, was hospitalized at the Department of Cardiac Surgery, Thoracic and Vascular Surgery of the FEFU Medical Center from 06/05/2018 to 08/24/2018, diagnosed with Postoperative Sternomediastinitis. The failure of the seams of the sternum.

From the anamnesis: 05/30/18, aortic valve replacement was performed with mechanical prosthesis Medinege No. 17 from regarding severe aortic stenosis. The postoperative period was complicated by the development of sternomediastinitis and instability of the sternum.

Due to the presence of an acute purulent process, a two-stage treatment approach was chosen. The first stage on 05.06.2018, the patient underwent an operation — surgical debridement of a post-steroidal wound with necrectomy and removal of the wire sutures of the sternum. From the same day (06/05/2018) - vacuum therapy in alternating mode was started (includes cyclic switching between two optimal pressure limits, with a certain interval - every 2-5 minutes) with negative pressure levels of -50 mm Hg. Art. (min) and -200 mmHg. Art. (max). For every 3-4 days, the wound was rehabilitated and the vacuum dressing was changed.

After the relief of acute inflammation and the production of stable (3-fold) negative bacterial cultures on 10.08.2018, secondary sutures were applied to the wound. The postoperative period was uneventful. The wound healed by secondary intention. The patient was discharged in satisfactory condition.

Claims (1)

The method of vacuum drainage of sternotomic wounds, including placing a wound of elastic porous material in the wound, covering the wound and the adjacent area with an insulating film, communicating the dressing with a drainage line through a collection container with a vacuum means, characterized in that the end of the drainage line is placed in the dressing volume and is performed perforated, with the insulating film tightly fixed out of contact with the wound surface on the perimeter of the insulating film, in addition, the vacuum is maintained in a variable p press either at a level of -50 mm Hg or at a level of from -150 to -200 mm Hg, while the duration of one level of vacuum is 2-5 minutes, after which the level of vacuum is changed to the second one, and it is also maintained for 2-5 minutes, then everything is repeated, and evacuation is carried out continuously for 12 hours daily and after a 12-hour break, it is resumed, in addition, evacuation using a single dressing is carried out for 3-5 days, after which the dressing is replaced with a new one and then everything is repeated, with the total duration of the process of healing Nia is 25-30 days.

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