A Prospective, Randomized, Phase III Study to Evaluate the Efficacy and Safety of Fibrin Sealant Grifols as an Adjunct to Hemostasis as Compared to Cellulose Sheets in Hepatic Surgery Resections

Bjelović, Miloš; Ayguasanosa, Jaume; Kim, Robin D.; Stojanović, Miroslav; Vereczkei, András; Nikolić, Srdjan; Winslow, Emily R.; Emre, Sükrü; Xiao, Gary; Navarro-Puerto, Jordi; Courtney, Kecia; Barrera, Gladis

doi:10.1007/s11605-018-3852-4

Cited by 16 publications

(16 citation statements)

References 28 publications

(38 reference statements)

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“…The main aim of these studies is not very clinically relevant, for example, Bjelović, et al [20] measure the time needed for hemostasis, which depends on every assessor. There are barely any differences between sealing agents according to the results, however, does that mean a decreased blood loss or a decrease in the number of blood transfusions?…”

Section: Discussionmentioning

confidence: 99%

Is the Use of Sealing and Hemostatic Agents Justified in Hepatic Resections? Review and Meta-analysis

Boscà¹,

Navío²,

Navasquillo-Tamarit³

et al. 2021

J Gastrointest Hepat Surg

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The use of biological hemostatic and sealing agents over the edge of the liver resection has been increasing exponentially for over 30 years but without solid literature review.The aim of this study was to produce a meta-analysis including only prospective and randomized studies to know real effect using hemostatic sealants on the resection edge after elective hepatic resection, especially regarding biliary fistula and hematoma.A literature search of the Medline and EMBASE was carried out to find prospective and randomized trials related to the use of hemostatic sealant in the surface of the liver resection compared with not using products after the usual revision of hemostasis.Six studies were included involving a total of 1002 patients in this meta-analysis. After analysing the results, the risk of developing hematoma/abscess or biliary leak was not related to the use of sealants. Odds Ratio [OR]: 1.19; 95% confidence interval [CI]: 0.79 -1.81; p=0,40 and OR: 1.02; 95% CI: 0.65-1.61; p=0.92 respectively. The use of sealants over the edge of the liver resection does not currently provide any benefit and its cost is not really justified.

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Section: Discussionmentioning

confidence: 99%

Is the Use of Sealing and Hemostatic Agents Justified in Hepatic Resections? Review and Meta-analysis

Boscà¹,

Navío²,

Navasquillo-Tamarit³

et al. 2021

J Gastrointest Hepat Surg

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“…Similarly disappointing results have been seen with a combination of bovine collagen and thrombin mixed then sprayed over the surgical bed [22]. Physical agents generally fare no better, as fibrin sealant has been shown to be roughly equivalent in terms of clinical outcomes when compared to either collagen powder or cellulose sheets in hepatic resections [23,24].…”

Section: Preventing and Maintaining Hemostasis In Hepatic Surgerymentioning

confidence: 99%

Use of Biosurgicals in Hepatobiliary Surgery

Clanton¹,

Seal²

2019

Contemporary Applications of Biologic Hemostatic Agents Across Surgical Specialties - Volume 2 [Working Title]

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Through innovative technologies and refinement of surgical technique over the last several decades, hepatopancreatobiliary (HPB) surgeries have become increasingly common for both malignant and benign disease. HBP surgeries often present unique challenges even for the experienced surgeon, whether due to liver cirrhosis causing portal hypertension and impairment of natural clotting abilities or a large pancreatic mass invading into nearby mesenteric vessels. Major intraoperative blood loss is still a concern and is known to be a major factor influencing morbidity and mortality. Biosurgicals are increasingly used as adjuncts to reduce blood loss during these complex procedures, but also to even reduce rates of biliary and pancreatic leaks and fistulas postoperatively. While initially biosurgical agents offered some hope to make the difference in completing a safe and effective operation, more recent and rigorous studies have failed to demonstrate reproducible benefits. This chapter reviews the use of hemostatic agents in the setting of hepatobiliary and pancreatic surgery, including for the maintenance of hemostasis and the prevention of biliary and pancreatic leaks. We also discuss what factors should be considered when choosing the correct agents for different clinical scenarios during HPB surgery.

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“…Surgical bleeding is a common complication in almost all forms of surgeries, and prompt bleeding control and appropriate hemostasis are vital for successful operation and to prevent complications, such as hematomas or excessive bleeding that can endanger the patient’s life 1 , 2 , 3 . Surgical bleeding can cause higher infection rates and ventilator use and prolong hospitalization and operative time 4 , 5 , 6 causing considerable clinical and financial burdens 4 , 7 , 8 .…”

Section: Introductionmentioning

confidence: 99%

“…It provides improved hemostasis and wound repair and enables sealing of wounded surfaces and tissues 1 , 10 , 11 , 12 , 13 . Such sealants possess several beneficial properties, namely quick activation, natural clotting process simulation, favorable safety profile, and reabsorbability 3 , 5 , 14 . Fibrin sealants have demonstrated better results than the conventional techniques for reducing intraoperative blood loss 5 , 13 , 15 , 16 , 17 .…”

Section: Introductionmentioning

confidence: 99%

Safety and efficacy of sFilm-FS, a novel biodegradable fibrin sealant, in Göttingen minipigs

Ramot

Steiner²,

Lavie³

et al. 2021

J Toxicol Pathol

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Bleeding during surgical procedures is a common complication. Therefore, hemostatic agents have been developed to control bleeding, and fibrin sealants have several benefits. sFilm-FS is a novel fibrin sealant that comprises a biodegradable copolymeric film embedded with human fibrinogen and thrombin. Herein, the safety and efficacy of sFilm-FS were compared using a liver and spleen puncture model of Göttingen minipigs with those of the standard hemostatic techniques (control animals) and EVARREST ® , a reference fibrin sealant. Hemostasis and reduced blood loss were more effectively achieved with sFilm-FS than with the standard techniques in the control animals and comparable to those achieved with EVARREST ® . No treatmentrelated adverse effects were observed in any of the groups. Histopathological evaluation indicated that sFilm-FS was slightly and moderately reactive at the liver puncture site and spleen, respectively, compared with the standard techniques in the control animals. These changes are expected degradation reactions of the copolymeric film and are not considered as adverse events. No treatment-related abnormalities were noted in the other evaluated organs. Additionally, no evidence of local or systemic thromboses was noted. These results support the use of sFilm-FS for hemostasis in humans.

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A Prospective, Randomized, Phase III Study to Evaluate the Efficacy and Safety of Fibrin Sealant Grifols as an Adjunct to Hemostasis as Compared to Cellulose Sheets in Hepatic Surgery Resections

Cited by 16 publications

References 28 publications

Is the Use of Sealing and Hemostatic Agents Justified in Hepatic Resections? Review and Meta-analysis

Is the Use of Sealing and Hemostatic Agents Justified in Hepatic Resections? Review and Meta-analysis

Use of Biosurgicals in Hepatobiliary Surgery

Safety and efficacy of sFilm-FS, a novel biodegradable fibrin sealant, in Göttingen minipigs

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