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

Objectives:Alveolarair leakageremains a serious problemin lung surgery, beingassociatedwith 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 W , inlungsurgery.Methods:Patientsundergoingelectivepulmonarylobectomywhohad grade1 or 2air leakage(evaluatedbythewatersubmersion test) after primary stapling and limited suturing were randomised at 12 European centres to open-label treatment with TachoSil W or standard surgicaltreatment(resuturing, staplingor nofurthertreatmentat thesurgeons’discretion).Randomisationwas performedduringsurgeryusinga centralisedinteractive voice response system. Durationof postoperative air leakage (primary end point), reductionof 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 W , n = 148; standard treatment, n = 151). TachoSil W resulted in a reduction in the duration of postoperative air leakage (p = 0.030). Patients in the TachoSil W 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 W 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 W 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.