title: Efficacy and safety of TachoSil® versus standard treatment of air leakage after pulmonary lobectomy.
abstract: OBJECTIVE
  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.
authors.affiliation: Vienna University Hospital, Vienna, Austria.
authors.forename: Gabriel Mihai
authors.initials: GM
authors.lastname: Marta
authors.forename: Francesco
authors.initials: F
authors.lastname: Facciolo
authors.forename: Lars
authors.initials: L
authors.lastname: Ladegaard
authors.forename: Hendrik
authors.initials: H
authors.lastname: Dienemann
authors.forename: Attila
authors.initials: A
authors.lastname: Csekeo
authors.forename: Federico
authors.initials: F
authors.lastname: Rea
authors.forename: Sebastian
authors.initials: S
authors.lastname: Dango
authors.forename: Lorenzo
authors.initials: L
authors.lastname: Spaggiari
authors.forename: Vilhelm
authors.initials: V
authors.lastname: Tetens
authors.forename: Walter
authors.initials: W
authors.lastname: Klepetko
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000388:Air; D015505:Chest Tubes; D004322:Drainage; D004338:Drug Combinations; D005260:Female; D005340:Fibrinogen / Q000627:therapeutic use*; D006801:Humans; D007902:Length of Stay / Q000706:statistics & numerical data; D008175:Lung Neoplasms / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D011013:Pneumonectomy / Q000009:adverse effects* / Q000379:methods; D011030:Pneumothorax / Q000517:prevention & control; D011182:Postoperative Care / Q000379:methods; D011183:Postoperative Complications; D011446:Prospective Studies; D015503:Surgical Sponges; D017792:Surgical Stapling; D013536:Suture Techniques; D013917:Thrombin / Q000627:therapeutic use*; D013997:Time Factors; D014014:Tissue Adhesives / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D004338:Drug Combinations; C518955:TachoSil; D014014:Tissue Adhesives; D005340:Fibrinogen; D013917:Thrombin