Antonio D'Andrilli1, Ilenia Cavaliere2, Giulio Maurizi3, Claudio Andreetti3, Anna Maria Ciccone3, Mohsen Ibrahim3, Rossella Baldini4, Federico Venuta5, Erino A Rendina6. 1. Department of Thoracic Surgery, Sant'Andrea Hospital, Sapienza University, Rome, Italy adandrilli@hotmail.com. 2. Department of Thoracic Surgery, Sant'Andrea Hospital, Sapienza University, Rome, Italy University of Pisa, Pisa, Italy. 3. Department of Thoracic Surgery, Sant'Andrea Hospital, Sapienza University, Rome, Italy. 4. Department of Statistics, Sapienza University, Rome, Italy. 5. Department of Thoracic Surgery, Policlinico Umberto I, Sapienza University, Rome, Italy Lorillard Spencer Cenci Foundation, Rome, Italy. 6. Department of Thoracic Surgery, Sant'Andrea Hospital, Sapienza University, Rome, Italy Lorillard Spencer Cenci Foundation, Rome, Italy.
Abstract
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 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.
RCT Entities:
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 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.