Efficacy and safety of human fibrinogen-thrombin patch (TachoSil®) in the treatment of postoperative air leakage in patients submitted to redo surgery for lung malignancies: a randomized trial.

OBJECTIVES: Previous studies of the human fibrinogen-thrombin patch TachoSil® for air leak management in thoracic surgery have excluded patients undergoing redo surgery, a group at high risk of persistent air leaks. This is the first study to assess TachoSil® in patients undergoing redo surgery.
METHODS: Patients who had undergone pulmonary resection for primary lung cancer or lung metastasis and were scheduled for completion lobectomy plus lymphadenectomy due to tumour recurrence were eligible. After complete lobectomy, patients with intraoperative Macchiarini grade 3 air leaks (or >30% of the tidal volume at plethysmographic assessment) were randomized to receive either TachoSil® or further lung parenchymal stapling/suturing procedures according to standard surgical practice.
RESULTS: A total of 24 patients were randomized to TachoSil® (n = 13) or standard treatment (n = 11). Mean duration of surgery was significantly shorter in the TachoSil® group than in the standard group (3.6 vs 4.0 h; P = 0.023). The mean duration of air leaks was also significantly reduced in the TachoSil® group (4.7 vs 10.0 days; P < 0.001), and the removal of both the first and the second chest tubes occurred earlier (mean 3.8 vs 5.5 days; P = 0.005; and 6.1 vs 10.8 days; P < 0.001, respectively). TachoSil® was also effective in reducing persistent (≥ 9 days) air leaks (1 vs 7 patients; P = 0.008). There were no significant differences between groups in other postoperative complications. Mean length of hospital stay was significantly shorter in TachoSil®-treated patients (6.9 vs 9.5 days; P < 0.001).
CONCLUSIONS: TachoSil® was superior to standard stapling and suturing aerostatic techniques in reducing postoperative air leaks in patients undergoing redo thoracic surgery.

RCT Entities:   Population Interventions Outcomes