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Эндоскопия/Колопроктология
Efficacy evaluation of the medicinal substance haemoblock hemostatic effect in the course of open
A. V. Plotkin
E.Z. Pokrovskiy
G.V. Voronova
K.A. Menglet
Experience sharing

The effective intraoperative arrest of hemorrhage and mitigation of risk of infectious complications in the postoperative period is a challenging issue, and in this regard the new topical hemostatic agent haemoblock with a bactericidal function is of considerable interest. The medical substance Haemoblock is a topical hemostatic agent registered in the Russian Federation as a medical product. Its formula includes partial silver salt of
polyacrylic acid, containing silver nanoparticles, which determines a marked bactericidal and bacteriostatic effect of haemoblock. The substance is applied topically in cases of
parenchymal and capillary hemorrhage. Sterile cotton wool or gauze tampons are soaked with the substance and applied to the bleeding, preliminarily dried up surface of the
wound. In case of vast wound surfaces the substance is used in a form of spray. The hemostatic effect is achieved within 12 minutes. Since haemoblock forms a clot with plasma proteins (mainly, albumin) the hemostatic effect is achieved. Recent studies conducted in the laboratory of the Moscow Regional Scientific-and-Research Blood Institute showed that the mode of haemoblock action does not depend on concentration of blood clotting proteins in plasma, but on albumin content mainly. At the first stage of the medical substance action, a polyacrylic matrix structure is formed which contains albumin molecules in the cells of polyacrylic matrix. This is a primary structure and its life cycle is not too long, since polyacrylate anion does not create strong connections with protein molecules and is sustained only due to weak bonds. But this structure is a primary organizer of a sustainable film. At the next stage silver ions are reduced by albumin
molecules, thus forming a steady complex: polyacrylate anions form a strong bond with positively charged protein molecules. Such structure is packed in several micro-layers, creating a strong polymethacrylate film on the wound surface. Provided that the reduced metal like silver in complex with proteins is a potent bactericidal factor that ensures absence of wound infection when using haemoblock. At a later stage the haemoblock protein surface structure is replaced by fibrin. Whereas the polyacrylate matrix is plasmolyzed within 24 hours. The objective of this trial is to evaluate the hemostatic effect of the medicinal substance haemoblock in the course of open and laparoscopic surgeries.
Material and methods.

A multi-center trial was conducted in order to evaluate the efficacy of local hemostasis when using the Haemoblock medicinal substance. The study covered 89 patients who underwent treatment in four medical treatment facilities of the Russian Federation:
1. Hospital Surgery Clinic of the Regional Budgetary Institution of Health "City Clinical Hospital No. 4" of the city of Ivanovo.
2. The Surgical center of NGHCI Central Clinical Hospital No1 of Russian Railways, Moscow
3. The Endoscopy Department of the State Budgetary Institution of Health "Chelyabinsk regional clinical hospital No. 3"
4. The Endoscopy Department of the Central District Hospital, the City of Kineshma, the Ivanovo region.
Patients were subdivided into 3 groups. Each group was characterized by the way of Haemoblock delivery to the wound surface.
1. 31 patients underwent the surgical treatment in regard to destructive cholecystitis. The operations were conducted by a videolaparoscopic method. Haemoblock was applied to the bleeding surface by a well-wetted gauze pad delivered to the wound surface through the 5 mm tube.
2. 35 patients with acute surgical pathology of abdominal organs, major vessels and skeleton bones underwent the abdominal surgery (open surgery) of different types.
Haemoblock was applied to the open bleeding surface by a well-wetted gauze pad.
3. 23 patients with various surgical and cancer pathologies were operated by the laparoscopic method. Haemoblock was delivered to the bleeding surface in a
laparoscopic way by targeted irrigation via a catheter introduced through ezophagogastroduodenoscope.
Trial progress.
1. The Hospital Surgery Clinic of the Regional Budgetary Institution of Health "City Clinical Hospital No. 4", Ivanovo, the group led by Evgeniy Z. Pokrovskiy, D.M., A.P., Head of the Chair of the Hospital Surgery of the State Budget Educational Institution of Higher Professional Education "Ivanovo State Medical Institution of the Ministry of Health of
Russia", Ivanovo, Russia An open, prospective study involved 39 patients. The
medicinal substance was used in cases of diffusive (capillary) bleedings from the liver tissue in patients who underwent surgical treatment of acute surgical pathology.
The basic group of immediate causes comprised the acute calculous destructive cholecystitis (79.5%) and focal lesions of liver (intrahepatic abscesses - 7.7%; metastatic
lesions - 12.8%). Surgical treatment of the acute destructive cholecystitis was performed urgently, in all cases videolaparoscopical cholecystectomy was used. In the course of surgery in this group of patients the diffusive bleeding from the gallbladder bed was the most frequent case. The antibacterial effect of haemoblock is an important aspect of its usage, critical in cases of destructive cholecystitis. As it is known, additional and excessive coagulation of a gallbladder bed during surgery often does not provide an adequate hemostatic effect. An additional area of coagulation necrosis is formed, whereas this area itself can be a source of hyperthermia and a substrate for purulent processes in the postoperative period. Mass lesions of liver diagnosed during examination or intraoperatively sometimes require atypical resections of the liver which are also accompanied by diffuse bleeding. In our cases of extensive purulent processes the surgery was performed using LigaSure device, whereas the biopsy materials were taken traditionally. It should be noted that in the studies conducted, even LigaSure did not always provide stable hemostasis on the liver surface. First of all, it is determined by the following device feature: closure of two jaws of clips and exclusion of the surface fragments with small vessels from the zone of action of the device. The more detailed characteristic of the underlying disease is presented in Table 1. Most patients were diagnosed with coexisting cardiovascular Pathology: hypertension (80.5%) and coronary heart disease (75.4%). Among females high incidence of chronic gynecological diseases of inflammatory origin and myomatous lesions of the uterus (84.8%) was registered, as
for males the high incidence of benign prostatic hyperplasia was observed (46.9%). In general the comorbidity structure reflects the level and nature of morbidity of population in the service area where a high percentage of diabetes, chronic diseases of lower limb veins (varicose veins, chronic venous insufficiency), and chronic respiratory diseases (chronic obstructive pulmonary disease, chronic bronchitis, bronchial asthma) is observed. There were 1.7 times as many females as males. The bulk of the patients were people of active working age. The most part of the observations concerns the patients of
elderly and senile age - 33.6%. The application methodology of the medicinal substance
was the following: during the open surgery a dry gauze pad was imposed on the wound for a short moment, immediately followed by an average sized gauze pad soaked
in 25-50 ml of Haemoblock. The exposition lasted for 2-3 min. In all cases the stable hemostasis was achieved (fig. 1 and 2).
Fig.1
Figure 2
Table 1
Clinical examples
Surgical report, patient B. Operation as of January 17, 2014 Resection of liver segment VI. Plugging the subhepatic space with a tampon. Surgical Procedure The abdomen was opened in layers in the right hypochondrium by Fedorov's incision. There is no effusion. In the sixth liver segment a destructive process in the form of detritus is detected (possibly tumor), no other seedings in the liver are observed. Taking into account the
localization and the character of affection, the resection of liver segment VI was performed using LigaSure. A gauze plug with Haemoblock was used. The laparotomy incision was closed in layers, followed by iodine and gauze dressing application.
Tissue specimen: a fragment of liver tissue with detritus for histopathological examination. Post-surgical diagnosis: Abscess (tumor destruction?) of liver segment VI.
Surgical report, patient M. Operation dd. March 31, 2014 Enucleation of a giant
cyst in the left hepatic lobe. Drainage and tamponing of abdominal cavity.
Surgical Procedure The skin and subcutaneous tissue were intersected by an incision in the right upper quadrant (with excision of an old post-operative scar) with transition to
the left upper quadrant. Hemostasis. Abdomen opening. Abdominal exploration. Due to an adhesive process in the subhepatic space and in the area of surgical approach the
full abdominal exploration is impossible. No signs of severe pathology are observed. Right and left hepatic lobes, gallbladder and extrahepatic bile ducts are located. Blunt
dissection helped to move away from the choledoch, hepaticus, right and left hepatic ducts. A liver cyst is located in the left hepatic lobe, on the border with the right lobe and
a fragment of normal liver tissue, over the diaphragmatic surface leftwards. The cyst size is about 12 to 14 cm. Taking into consideration its large size and previous oncotomy, a
radical cystectomy and the fibrous capsule removal are required. Enucleation of the cystic lesion was performed using the LigaSure device, though its spontaneous opening
with pyorrhea with sweetish odor could not be avoided. The cyst was removed within healthy tissues. Loose interrupted stitches are put in the gallbladder bed involving the
gastrocolic omentum and a tampon with Haemoblock. The haemostatic swab is applied over the liver, drainage is placed into the subhepatic area. Sanitation. Control of
hemostasis. The incision is closed in layers around drainage and tampons, followed by iodine and gauze dressing application. Tissue specimen: a cyst of the hepatic left lobe sized about 12 to 14 cm in diameter, the wall is about 2 to 3 mm. The cavity contains several subcavities, sent for histopathological examination. Post-surgical diagnosis: Infected multilocular cyst of the hepatic left lobe. During the videolaparoscopic operation the technique was slightly different. Irrigation of the gallbladder bed was performed with 5% chlorhexidine, the fluid was aspirated, and then through a pre-attached 5 mm tube a gauze pad soaked in Haemoblock (20-25 ml) was introduced to the gallbladder bed by a clamp and held it there for about 2 - 3 minutes. In all cases a stable hemostasis was achieved. It may be noted that as a result of Haemoblock application no recurrent bleeding occurred. At the same time, one can note a certain reduction in complications such as infiltration of the gallbladder area, subhepatic abscess and coagulative hyperthermia.
2. The Surgical Center of NGHCI Central Clinical Hospital No1 of Russian Railways, Moscow, a group led by M.V. Lysenko, Doctor of Medical Sciences, Professor, Honoured Doctor of the Russian Federation. Haemoblock was used in 27 patients aged from 30 to 76
years. 16 people among them suffered from cancer pathology (advanced cancer), 11 patients had the acute surgical pathology of abdominal organs, major vessels and
skeleton bones. As a result of clinical trials, in 23 cases a stable hemostatic effect was achieved, in 2 cases recurrent bleeding occurred: one of the patients required the repeated surgical intervention, whereas in another case a repeated application of Haemoblock with an exposure of 5 minutes was used. Haemoblock was ineffective twice: one patient had septic shock against the background of chronic cholangitis, with low and unstable blood pressure, the bleeding continued from abdominal adhesions, it was
arrested by application of Tachocomb plates and gauze tampons. And another patient had the bleeding from ureter continued despite the introduction of 10 ml of Haemoblock
(with the 5 min. exposure) to the ureter, as the ureter was connected with aortic aneurysm. Consequently nephrectomy and patch graft aortoplasty were performed [1].
3. The Endoscopy Department of the State Budgetary Institution of Health "Chelyabinsk regional clinical hospital No 3" , O.Y. Sitnikova, E.A. Tryasenogova, V.Y. Podshivalov
In modern endoscopic practice the techniques of endoscopic arrest and prevention of gastrointestinal bleedings are broadly demonstrated. They include electro coagulation, argon plasma coagulation, injection therapy, ligation, and clipping. All of them are indicated in the presence of local, specific source of bleeding (erosion, ulcers, arteriovenous fistula, etc.). The disadvantages of these methods include the high
cost of equipment and the difficulties in localizing the source of bleeding in less accessible areas. In the everyday endoscopic practice there are cases with sufficiently large area of lesions in the form of capillary, diffuse bleeding (Forrest IB bleeding), consequently the above-mentioned techniques of endoscopic hemostasis
cannot be applied (hemorrhagic gastropathy, chemical burn of the esophagus, chemical burn of stomach etc.) or when the source of bleeding is covered by a blood clot (Forrest IIB bleeding). The easiest and the most accessible endoscopic manipulation method in regard to such areas of bleeding is irrigation with hemostatic agents. Due to the
interaction of hemostatic agent with blood the blood clot is formed and tightly fixed to the wall of the organ. This method is effective in cases of continuous capillary bleeding and arrested bleeding. Currently in clinical practice there is a new hemostatic agent of topical application - Haemoblock - which has a non- specific mechanism of action. It interacts with blood proteins (mainly albumin) and forms a polymer complex that arrests
bleeding. The possibility of using this hemostatic agent in endoscopy in cases of Forrest IB and IIB bleedings was evaluated.
To this end, the irrigation of hemostatic agent through a catheter to the area of bleeding was applied to in 11 patients using a gastroduodenoscopic method. A bleeding site or
blood clots were irrigated with 20 ml of Haemoblock. All patients were males aged 44 to 77 years. Characteristics of sources and types of bleeding, effect of Haemoblock are presented in Table 2.
Table 2
With IIB type of bleeding we used the hemostatic agent if fresh, friable blood clots were present only. During theirirrigation the color change and size reduction of the clot due
to its compression were observed. As data in the Table 2 show in all the cases of
Haemoblock application no recurrent bleeding occurred.
Conclusions:
1. The technique of endoscopic application of Haemoblock is easy to perform and does not require any specific equipment.
2. The presence of bleeding of I B or II B type is one of the indications for irrigational endoscopic therapy with Haemoblock [2].
4. The Endoscopy Department of the Central District Hospital, the City of Kineshma, the Ivanovo region, a group led by G.V. Voronova, Deputy Chief Doctor for Clinical Care of the Regional Budgetary Institution of Health Kineshemskaya Central District Hospital , a doctor-endoscopist. The evaluation of Haemoblock effect in endoscopy and its comparison with hemostatic agent Caprofer were performed. Targeted irrigation was performed via a catheter inserted through ezophagogastroduodenoscope. 30 ml of
Haemoblock solution was used for irrigation of bleeding sites. Endoscopic hemostasis was performed in 24 patients with diffuse capillary bleeding and the presence of a blood
clot on the bleeding source. The study included male patients aged 44 to 77 years.
The characteristics of sources and types of bleeding, results of Haemoblock application are presented in Table 3.
Table 3
In cases of irrigation with Haemoblock reduction of blood clots size and change in their color were observed, while in case of Caprofer usage the size of clots increased. As it can
be seen in Table 3, in all cases of Haemoblock usage no recurrent bleeding occurred.
It is shown that in all patients of the 1st group (31 people) hemostasis occurred within 1 - 3 minutes. Secondary hemorrhage and suppuration were not fixed. In 31 patients of the 2nd group hemostasis occurred for1-3 minutes. Secondary hemorrhage and suppuration have not been recorded. In 2 patients of the 2nd group recurrentbleeding required repeated application of the hemostatic agent, in 2 patients of the 2nd group the hemostatic agent was ineffective.
In the third group in all 23 patients, reliable hemostasis with exposure up to 2 minutes was observed. In all cases no suppuration occurred.
Conclusions

Haemoblock is an effective topical hemostatic agent regardless of the method of application to the wound surface and anamnesis. This hemostatic agent produced effect in 95% of open surgery cases and in 100% cases of laparoscopic surgery.