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

@entity1 @entity86 @entity548 @entity954
OBJECTIVES: This prospective randomized study was designed to assess the safety and efficacy of a haemostatic matrix in @entity954 control and prevention of @entity86 after major lung surgery. METHODS: One hundred and twenty @entity1 undergoing major lung resection and presenting with intraoperative persistent active @entity548 have been prospectively enrolled and randomly assigned to receive [Floseal   group (FG)] or not (control group) the application of Floseal   to the @entity548 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 @entity1 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.
