Efficacy and safety of TachoSil® versus standard treatment of air leakage after pulmonary lobectomy

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Objectives: Alveolar air leakage remains a serious problem in lung surgery, being associated with increased postoperative morbidity, prolonged hospital stay and greater health-care costs. The aim of this study was to evaluate the sealing efficacy and safety of the surgical patch, TachoSil®, in lung surgery. Methods: Patients undergoing elective pulmonary lobectomy who had grade 1 or 2 air leakage (evaluated by the water submersion test) after primary stapling and limited suturing were randomised at 12 European centres to open-label treatment with TachoSil® or standard surgical treatment (resuturing, stapling or no further treatment at the surgeons' discretion). Randomisation was performed during surgery using a centralised interactive voice response system. Duration of postoperative air leakage (primary end point), reduction of intra-operative air leakage intensity (secondary end point) and adverse events (AEs), including postoperative complications, were assessed. Results: A total of 486 patients were screened and 299 received trial treatment (intent-to-treat (ITT) population: TachoSil®, n=148; standard treatment, n=151). TachoSil® resulted in a reduction in the duration of postoperative air leakage (p=0.030). Patients in the TachoSil® group also experienced a greater reduction in intra-operative air leakage intensity (p=0.042). Median time until chest drain removal was 4 days with TachoSil® and 5 days in the standard group (p=0.054). There was no difference between groups in hospital length of stay. AEs were generally similar in both groups, including postoperative complications. Conclusions: TachoSil® was superior to standard surgical treatment in reducing both postoperative air leakage duration and intra-operative air leakage intensity in patients undergoing elective pulmonary lobectomy. © 2010 European Association for Cardio-Thoracic Surgery.

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Marta, G. M., Facciolo, F., Ladegaard, L., Dienemann, H., Csekeo, A., Rea, F., … Klepetko, W. (2010). Efficacy and safety of TachoSil® versus standard treatment of air leakage after pulmonary lobectomy. European Journal of Cardio-Thoracic Surgery, 38(6), 683–689. https://doi.org/10.1016/j.ejcts.2010.03.061

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