title: A prospective, randomized, controlled trial of the efficacy and safety of fibrin pad as an adjunct to control soft tissue bleeding during abdominal, retroperitoneal, pelvic, and thoracic surgery.
abstract: BACKGROUND
  This study evaluated the hemostatic effectiveness and safety of Fibrin Pad (Omrix Biopharmaceuticals Ltd.) vs absorbable hemostat in patients undergoing nonemergent surgery. Fibrin Pad is a topical absorbable hemostat designed to be effective in a variety of soft tissues and across multiple bleeding intensities.
  
  
  METHODS
  Patients 18 years and older, requiring abdominal, retroperitoneal, pelvic, or thoracic (noncardiac) surgery and with an appropriate soft-tissue target bleeding site (TBS), were randomized to receive Fibrin Pad or absorbable hemostat (NCT00658723). Patients were stratified by bleeding severity at the TBS. Assessments included percentage of patients achieving hemostasis at 4 minutes after randomization with no rebleeding requiring treatment during the subsequent 6 minutes (primary endpoint), proportion of patients achieving hemostasis at 10 minutes, and incidence of treatment failure.
  
  
  RESULTS
  On the primary endpoint, 98.3% of patients with Fibrin Pad and 53.3% with absorbable hemostat achieved hemostasis at 4 minutes (p < 0.0001). The treatment differential was magnified (efficacy was maintained with Fibrin Pad but decreased with absorbable hemostat) with increasing bleeding intensity: in patients with mild bleeding, 100.0% vs 80.0% achieved hemostasis with Fibrin Pad and absorbable hemostat (p = 0.03), respectively; rates were 96.6% vs 26.7%, respectively (p < 0.0001) with moderate bleeding. Percentages of patients who achieved hemostasis at 10 minutes were: Fibrin Pad, 98.3% and absorbable hemostat, 73.3% (p < 0.0001). Incidences of adverse events were comparable between groups.
  
  
  CONCLUSIONS
  Fibrin Pad is superior to absorbable hemostat (SURGICEL Original Absorbable Hemostat [Ethicon]) in soft-tissue bleeding control and is safe and effective as an adjunct for rapidly and reliably achieving hemostasis for soft-tissue bleeding during surgery.
authors: The Methodist Hospital and Weill Medical College of Cornell University, Houston, TX 77030, USA. CPFischer@tmhs.org
authors: Craig P
authors: CP
authors: Fischer
authors: Grant
authors: G
authors: Bochicchio
authors: Jessica
authors: J
authors: Shen
authors: Bababhai
authors: B
authors: Patel
authors: Jonathan
authors: J
authors: Batiller
authors: James C
authors: JC
authors: Hart
mesh_terms: D000005:Abdomen / Q000601:surgery*; D016063:Blood Loss, Surgical / Q000517:prevention & control*; D002483:Cellulose, Oxidized / Q000627:therapeutic use*; D005260:Female; D005337:Fibrin / Q000627:therapeutic use*; D006488:Hemostasis, Surgical / Q000379:methods*; D006490:Hemostatics / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010388:Pelvis / Q000601:surgery*; D011446:Prospective Studies; D012187:Retroperitoneal Space / Q000601:surgery*; D013903:Thoracic Surgery; D016896:Treatment Outcome; D014481:United States
chemical_list: D002483:Cellulose, Oxidized; D006490:Hemostatics; C013695:Surgicel; D005337:Fibrin
keywords: AE; ITT; TBS; adverse event; intention to treat; target bleeding site