title: Fibrin Sealant Patch (TachoSil) vs Oxidized Regenerated Cellulose Patch (Surgicel Original) for the Secondary Treatment of Local Bleeding in Patients Undergoing Hepatic Resection: A Randomized Controlled Trial.
abstract: BACKGROUND
  Local hemostatic agents are important for the control of bleeding during liver resection when standard surgical techniques are insufficient.
  
  
  METHODS
  This was a multicenter, randomized, open-label study to compare fibrin sealant patch (FSP; TachoSil; Takeda Pharma A/S) with oxidized regenerated cellulose gauze (ORCG; Surgicel Original; Ethicon) for the secondary treatment of local bleeding after hepatic resection in adult and pediatric patients. Primary end point was the proportion of adult patients with intraoperative hemostasis at the target bleeding site within 3 minutes of application of treatment.
  
  
  RESULTS
  Of 321 adult patients screened, 224 patients had minor to moderate bleeding from the hepatic resection area after primary hemostatic treatment and were intraoperatively randomized to FSP (n = 114) or ORCG (n = 110). Hemostasis within 3 minutes was achieved in 92 patients in the FSP group (80.7%) and 55 patients in the ORCG group (50.0%) (odds ratio = 4.87; 95% CI, 2.55-9.29; p < 0.001). The proportion of patients with hemostasis at 5 minutes was also higher in the FSP group (94.7% vs 76.4%; odds ratio = 6.24; 95% CI, 2.39-16.30; p < 0.001), and time to hemostasis was shorter (p < 0.001). At 10 minutes, hemostasis was achieved in all patients in the FSP group and 12 patients in the ORCG group (10.9%) had visible bleeding and required hemostatic rescue therapy. In pediatric patients, hemostasis at 3 minutes was achieved in 17 of 20 (85.0%) patients with FSP and 4 of 9 (44.4%) patients with ORCG. Both treatments were well tolerated in adults and children.
  
  
  CONCLUSIONS
  The FSP (TachoSil) was safe and superior to ORCG (Surgicel Original) for achieving hemostasis in patients undergoing hepatic resection. ClinicalTrials.gov ID NCT01192022.
authors.affiliation: Keck Medical Center of University of Southern California, Los Angeles, CA. Electronic address: yuri.genyk@health.usc.edu.
authors.forename: Yuri
authors.initials: Y
authors.lastname: Genyk
authors.affiliation: Columbia University Medical Center, New York, NY.
authors.forename: Tomoaki
authors.initials: T
authors.lastname: Kato
authors.affiliation: Lahey Clinic Medical Center, Burlington, MA.
authors.forename: James J
authors.initials: JJ
authors.lastname: Pomposelli
authors.affiliation: Hepatobiliary Surgery and Liver Transplantation, Vanderbilt University, Nashville, TN.
authors.forename: J Kelly
authors.initials: JK
authors.lastname: Wright
authors.affiliation: Keck Medical Center of University of Southern California, Los Angeles, CA.
authors.forename: Linda S
authors.initials: LS
authors.lastname: Sher
authors.affiliation: Takeda Development Centre Europe, London, UK.
authors.forename: Vilhelm
authors.initials: V
authors.lastname: Tetens
authors.affiliation: Division of General Surgery, Washington University in St Louis, MO.
authors.forename: William C
authors.initials: WC
authors.lastname: Chapman
mesh_terms: D000328:Adult; D000368:Aged; D002483:Cellulose, Oxidized / Q000627:therapeutic use*; D004338:Drug Combinations; D005260:Female; D005340:Fibrinogen / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006488:Hemostasis, Surgical / Q000379:methods*; D006490:Hemostatics / Q000627:therapeutic use*; D006498:Hepatectomy; D006801:Humans; D008297:Male; D008875:Middle Aged; D019106:Postoperative Hemorrhage / Q000628:therapy*; D011446:Prospective Studies; D013917:Thrombin / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D002483:Cellulose, Oxidized; D004338:Drug Combinations; D006490:Hemostatics; C518955:TachoSil; C013695:Surgicel; D005340:Fibrinogen; D013917:Thrombin