title: Evaluation of the efficacy of a haemostatic matrix for control of intraoperative and postoperative bleeding in major lung surgery: a prospective randomized study.
abstract: OBJECTIVE
  This prospective randomized study was designed to assess the safety and efficacy of a haemostatic matrix in intraoperative bleeding control and prevention of postoperative bleeding after major lung surgery.
  
  
  METHODS
  One hundred and twenty patients undergoing major lung resection and presenting with intraoperative persistent active bleeding have been prospectively enrolled and randomly assigned to receive [Floseal® group (FG)] or not (control group) the application of Floseal® to the bleeding site and to the site of the hilar dissection. To evaluate the efficacy of the product, several intraoperative and postoperative data were compared between the two groups.
  
  
  RESULTS
  No adverse event related to the haemostatic matrix application occurred. The intraoperative haemostasis rate at 3 (primary end-point), 6 and 10 min was significantly higher and the mean time to haemostasis was significantly shorter in the FG. The quantity of chest drain fluids did not show significant differences at 24, 48 and 72 h between the two groups. Postoperative haemoglobin-level variation was significantly lower in patients of the FG (-0.7 ± 0.66 vs -2.3 ± 5.87 g/dl; P = 0.04). Similarly, haematocrit variation was lower in the haemostatic group (-2.6 ± 2.19 vs -4.2 ± 3.71; P = 0.006). The chest drain duration resulted significantly shorter in the FG (10.3 ± 5.05 vs 13.3 ± 6.28 days; P = 0.005). In-hospital stay was shorter in the FG (6.4 ± 2.9 vs 8.1 ± 5.42 days; P = 0.044).
  
  
  CONCLUSIONS
  In conclusion, the application of Floseal® in major lung resections proved safe and effective in increasing the intraoperative successful haemostasis rate and in reducing postoperative variation in haemoglobin and haematocrit levels. The sealant use was also related with a significantly shorter chest drain duration and hospitalization.
authors.affiliation: Department of Thoracic Surgery, Sant'Andrea Hospital, Sapienza University, Rome, Italy adandrilli@hotmail.com.
authors.forename: Antonio
authors.initials: A
authors.lastname: D'Andrilli
authors.affiliation: Department of Thoracic Surgery, Sant'Andrea Hospital, Sapienza University, Rome, Italy University of Pisa, Pisa, Italy.
authors.forename: Ilenia
authors.initials: I
authors.lastname: Cavaliere
authors.affiliation: Department of Thoracic Surgery, Sant'Andrea Hospital, Sapienza University, Rome, Italy.
authors.forename: Giulio
authors.initials: G
authors.lastname: Maurizi
authors.affiliation: Department of Thoracic Surgery, Sant'Andrea Hospital, Sapienza University, Rome, Italy.
authors.forename: Claudio
authors.initials: C
authors.lastname: Andreetti
authors.affiliation: Department of Thoracic Surgery, Sant'Andrea Hospital, Sapienza University, Rome, Italy.
authors.forename: Anna Maria
authors.initials: AM
authors.lastname: Ciccone
authors.affiliation: Department of Thoracic Surgery, Sant'Andrea Hospital, Sapienza University, Rome, Italy.
authors.forename: Mohsen
authors.initials: M
authors.lastname: Ibrahim
authors.affiliation: Department of Statistics, Sapienza University, Rome, Italy.
authors.forename: Rossella
authors.initials: R
authors.lastname: Baldini
authors.affiliation: Department of Thoracic Surgery, Policlinico Umberto I, Sapienza University, Rome, Italy Lorillard Spencer Cenci Foundation, Rome, Italy.
authors.forename: Federico
authors.initials: F
authors.lastname: Venuta
authors.affiliation: Department of Thoracic Surgery, Sant'Andrea Hospital, Sapienza University, Rome, Italy Lorillard Spencer Cenci Foundation, Rome, Italy.
authors.forename: Erino A
authors.initials: EA
authors.lastname: Rendina
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D006490:Hemostatics / Q000627:therapeutic use*; D006801:Humans; D008168:Lung / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D011013:Pneumonectomy / Q000009:adverse effects* / Q000706:statistics & numerical data; D019106:Postoperative Hemorrhage / Q000628:therapy*; D011446:Prospective Studies
chemical_list: D006490:Hemostatics
keywords: Complications; Lobectomy; Major lung surgery