title: Efficacy and safety of fibrin sealant patch in the treatment of air leakage in thoracic surgery.
abstract: OBJECTIVE
  Air leakage represents a major problem in lung surgery. Absorbable fibrin sealant patch (AFSP), a collagen sponge coated with human fibrinogen and thrombin, can be used as an adjunct to primary stapling or suturing. This study compared the efficacy of AFSP with manual suturing after primary stapling.
  
  
  METHODS
  This was a prospective, multicenter, randomized study. Patients undergoing lobectomy, bilobectomy, anatomical segmentectomy for lung cancer or wedge resection for pulmonary metastasis with air leakage grade 1 or 2 according to Macchiarini scale after stapler suture were randomized to receive AFSP or standard surgical treatment (ST). The primary endpoint was the reduction of intraoperative air leakage intensity. Duration of postoperative air leakage and number of days until removal of last chest drain were secondary endpoints. Safety was recorded for all patients.
  
  
  RESULTS
  A total of 346 patients were enrolled in 14 centres, 179 of whom received AFSP and 167 ST. Intraoperative air leak intensity was reduced in 90.5% of AFSP patients and 82% of ST patients (P=0.03). A significant reduction in postoperative air leakage duration was observed in the AFSP group (P=0.0437). The median number of days until removal of last drainage was 6 (3-37) in the AFSP group and 7 (2-27) in the ST (P=0.38). Occurrence of adverse events was comparable in both groups.
  
  
  CONCLUSIONS
  AFSP was more efficacious than standard ST as an adjunct to primary stapling in reducing intraoperative air leakage intensity and duration of postoperative air leakage in patients undergoing pulmonary surgery. AFSP was well tolerated.
authors.affiliation: Division of Thoracic Surgery Vito Fazzi Hospital, Lecce, Italy - gaetano.dirienzo@libero.it.
authors.forename: C
authors.initials: C
authors.lastname: Lopez
authors.forename: F
authors.initials: F
authors.lastname: Facciolo
authors.forename: C
authors.initials: C
authors.lastname: Lequaglie
authors.forename: E A
authors.initials: EA
authors.lastname: Rendina
authors.forename: S
authors.initials: S
authors.lastname: Saita
authors.forename: D
authors.initials: D
authors.lastname: Dell'Amore
authors.forename: F
authors.initials: F
authors.lastname: Sollitto
authors.forename: G
authors.initials: G
authors.lastname: Urciuoli
authors.forename: M
authors.initials: M
authors.lastname: Loizzi
authors.forename: M L
authors.initials: ML
authors.lastname: Cisternino
authors.forename: P
authors.initials: P
authors.lastname: Granone
authors.forename: A
authors.initials: A
authors.lastname: Angelelli
authors.forename: G
authors.initials: G
authors.lastname: Cardillo
authors.forename: F
authors.initials: F
authors.lastname: Mucilli
authors.forename: G
authors.initials: G
authors.lastname: Di Rienzo
mesh_terms: D000368:Aged; D000388:Air; D057868:Anastomotic Leak / Q000628:therapy*; D005260:Female; D015718:Fibrin Tissue Adhesive / Q000009:adverse effects; D006801:Humans; D008175:Lung Neoplasms / Q000601:surgery*; D008297:Male; D011013:Pneumonectomy / Q000379:methods*; D011446:Prospective Studies; D019616:Thoracic Surgical Procedures
chemical_list: D015718:Fibrin Tissue Adhesive