title: Efficacy of a haemostatic matrix for the management of bleeding in patients undergoing liver resection: results from 237 cases.
abstract: BACKGROUND
  The haemostatic matrix (FloSeal) is a topical agent that provides effective haemostasis in a range of surgical applications. We evaluated this sealant for intraoperative haemostatic effectiveness in an observational series of patients undergoing surgery for the resection of primary and metastatic liver tumours.
  
  
  METHODS
  A haemostatic matrix was applied directly to areas of bleeding. The severity of bleeding before and after application was graded on a 5-point scale (0 = no bleeding, 1 = oozing, 2 = moderate blood flow, 3 = heavy blood flow, 4 = spurting blood). The time to complete haemostasis was also recorded.
  
  
  RESULTS
  105 women (age 61 +/- 9 years) and 132 men (age 61 +/- 12 years) were included in this study. One hundred and seventeen patients (49.36%) had pre-operative coagulopathy resulting from co-existent cirrhosis (67 Child-Pugh Class A; 50 Child-Pugh Class B). Prior to administration of a haemostatic matrix, 93 bleeding sites (24.8%) had a bleeding severity score of 2, 269 bleeding sites (71.7%) had a score of 3 and 13 bleeding sites (3.5%) had a score of 4. Following administration of the haemostatic matrix, bleeding stopped completely (score of 0) at 367 (97.9%) of the 375 sites and was reduced to a score of 1 at the remaining 8 sites (2.1%), of which only 2 were in patients with coagulopathy. The mean time to achieve haemostasis in the overall population was 2.9 +/- 1 min; this was significantly increased in patients with coagulopathy versus noncoagulopathic patients (4 +/- 1 vs. 2 +/- 1 min, p < 0.001).
  
  
  CONCLUSIONS
  In this prospective, uncontrolled study of 237 consecutive patients undergoing major hepatic surgery to remove primary or metastatic tumours, application of a haemostatic matrix provided rapid and effective intraoperative control of mild to severe bleeding from the liver edge, even in patients with prolonged bleeding times resulting from cirrhosis. This preliminary evidence warrants a randomised, controlled clinical trial with a larger sample size.
authors.affiliation: The G. Pascale National Cancer Institute, Naples, Italy. izzo@connect.it
authors.forename: Francesco
authors.initials: F
authors.lastname: Izzo
authors.forename: Raimondo
authors.initials: R
authors.lastname: Di Giacomo
authors.forename: Paolo
authors.initials: P
authors.lastname: Falco
authors.forename: Mauro
authors.initials: M
authors.lastname: Piccirillo
authors.forename: Rossana
authors.initials: R
authors.lastname: Iodice
authors.forename: Antonio Pio
authors.initials: AP
authors.lastname: Orlando
authors.forename: Pasquale
authors.initials: P
authors.lastname: Aprea
authors.forename: Francesco
authors.initials: F
authors.lastname: Cremona
authors.forename: Massimiliano
authors.initials: M
authors.lastname: Di Marzo
authors.forename: Domenico Nicola
authors.initials: DN
authors.lastname: Idà
authors.forename: Angelo A
authors.initials: AA
authors.lastname: Mastro
authors.forename: Steven A
authors.initials: SA
authors.lastname: Curley
mesh_terms: D016063:Blood Loss, Surgical / Q000517:prevention & control*; D005260:Female; D005782:Gels; D006487:Hemostasis / Q000187:drug effects*; D006498:Hepatectomy / Q000379:methods*; D006801:Humans; D007558:Italy; D008113:Liver Neoplasms / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D019106:Postoperative Hemorrhage / Q000517:prevention & control*; D011446:Prospective Studies; D013917:Thrombin / Q000008:administration & dosage*; D013997:Time Factors
chemical_list: D005782:Gels; D013917:Thrombin