title: Efficacy and safety of topical application of human fibrinogen/thrombin-coated collagen patch (TachoComb) for treatment of air leakage after standard lobectomy.
abstract: OBJECTIVE
  Persisting air leakage after pulmonary resection remains a significant problem. The aim of the study was to evaluate the incidence of air leakage after standard lobectomy and test the efficacy and safety of TachoComb (TC).
  
  
  METHODS
  A total of 189 patients undergoing lobectomy were enrolled in a multi-centre, open, randomised, and prospective study to test the efficacy and safety of TachoComb (TC) for air leakage treatment. Air leakage was assessed by water submersion test, and scored as grades 0 if no, 1 if countable, 2 if a stream of and 3 if coalescent bubbles have been observed. Any sites with grade 3 air leakage received further stapling or limited suturing until grade 0, 1 or 2 was obtained. Treatment of air leakage was done with TC or suturing according to randomisation. Air leakage was assessed by further submersion tests. Postoperative air leakage was assessed using the Pleur-Evac system.
  
  
  RESULTS
  Overall incidence of air leakage 48+/-6 h after surgery was 34% for TC and 37% for standard treatment (P=0.76). The reduction of intra-operative air leak intensity in the subgroup with grades 1-2 was significantly higher for the TC group (P=0.015). Postoperative air leakage intensity in the subgroup with air leakage grades 1-2 was lower for TC than standard treatment (P=0.047). The mean duration of postoperative air leakage in the subgroup with grades 1-2 was shorter for the TC group than for standard treatment, i.e. 1.9+/-1.4 vs. 2.7+/-2.2 days (P=0.015).
  
  
  CONCLUSIONS
  TC could be proven as well-tolerated and safe. In the subgroup of patients with established air leakage, TC showed superior potential in reduction of intra-operative air leakage as well as in reduction of intensity and duration of postoperative air leakage.
authors.affiliation: Thoracic Surgery Clinic, Korányi National Institute for Pulmonology, Budapest, Hungary.
authors.forename: György
authors.initials: G
authors.lastname: Lang
authors.forename: Attila
authors.initials: A
authors.lastname: Csekeö
authors.forename: Georgios
authors.initials: G
authors.lastname: Stamatis
authors.forename: Ludwig
authors.initials: L
authors.lastname: Lampl
authors.forename: Leif
authors.initials: L
authors.lastname: Hagman
authors.forename: Gabriel Mihai
authors.initials: GM
authors.lastname: Marta
authors.forename: Michael Rolf
authors.initials: MR
authors.lastname: Mueller
authors.forename: Walter
authors.initials: W
authors.lastname: Klepetko
mesh_terms: D000368:Aged; D007611:Aprotinin / Q000627:therapeutic use*; D020099:Coated Materials, Biocompatible / Q000627:therapeutic use; D004338:Drug Combinations; D005260:Female; D005340:Fibrinogen / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011013:Pneumonectomy / Q000009:adverse effects*; D011030:Pneumothorax / Q000209:etiology / Q000628:therapy*; D011184:Postoperative Period; D011446:Prospective Studies; D012720:Severity of Illness Index; D013917:Thrombin / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D020099:Coated Materials, Biocompatible; D004338:Drug Combinations; C093991:tachocomb; D005340:Fibrinogen; D007611:Aprotinin; D013917:Thrombin