Evaluation of the efficacy of a haemostatic matrix for control of intraoperative and postoperative bleeding in major lung surgery. a prospective randomized study

OBJECTIVES: 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 diffe