title: Prospective European multicenter randomized trial of PleuraSeal for control of air leaks after elective pulmonary resection.
abstract: OBJECTIVE
  We sought to evaluate the efficacy and safety of a synthetic bioresorbable pleural sealant (PleuraSeal; Covidien, Bedford, Mass) to treat air leaks after pulmonary resection.
  
  
  METHODS
  Patients with air leaks after lung resection were randomized to treatment with pleural sealant on air leak sites after standard methods of lung closure or standard lung closure only. The primary outcome variable was the percentage of patients remaining air leak free until discharge. The secondary outcome variables were the proportion of patients with successful intraoperative air leak sealing, time to last air leak, and durations of chest tube drainage and hospitalization.
  
  
  RESULTS
  The sealant group comprised 62 subjects, and the control group comprised 59 subjects. Most patients (98.3%) underwent open lobectomy for bronchogenic carcinoma. The overall success rates for intraoperative air leak sealing were as follows: sealant group, 71.0%; control group, 23.7% (P < .001). For grade 2 and 3 air leaks (n = 77), the intraoperative sealing rates were as follows: sealant group, 71.7%; control group, 9.1% (P < .001). More patients with grade 2 and 3 air leaks had their leaks remain sealed in the sealant group (43.5% vs 15.2%, P = .013). The median time from skin closure to last observable air leak was 6 hours (sealant group) versus 42 hours (control group, P = .718). No treatment-related complications were reported. No differences in drainage or hospitalization were observed.
  
  
  CONCLUSIONS
  In this multicenter study the pleural sealant was safe and effective treatment for intraoperative air leaks after lung resection. Significantly fewer patients with surgically relevant intraoperative air leaks had postoperative air leaks when the pleural sealant was applied.
authors.affiliation: University Hospitals Leuven, Leuven, Belgium. Paul.deleyn@uz.kuleuven.ac.be
authors.forename: Paul
authors.initials: P
authors.lastname: De Leyn
authors.forename: Michael-Rolf
authors.initials: MR
authors.lastname: Muller
authors.forename: Jan Wolter A
authors.initials: JW
authors.lastname: Oosterhuis
authors.forename: Thomas
authors.initials: T
authors.lastname: Schmid
authors.forename: Cliff K C
authors.initials: CK
authors.lastname: Choong
authors.forename: Walter
authors.initials: W
authors.lastname: Weder
authors.forename: Youri
authors.initials: Y
authors.lastname: Sokolow
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001672:Biocompatible Materials; D015505:Chest Tubes; D005060:Europe; D005260:Female; D006801:Humans; D007442:Intubation, Intratracheal / Q000295:instrumentation; D053208:Kaplan-Meier Estimate; D007902:Length of Stay; D008175:Lung Neoplasms / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D011013:Pneumonectomy / Q000009:adverse effects*; D011030:Pneumothorax / Q000209:etiology / Q000628:therapy*; D011446:Prospective Studies; D016037:Single-Blind Method; D013908:Thoracotomy / Q000009:adverse effects*; D013997:Time Factors; D014014:Tissue Adhesives / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D058106:Wound Closure Techniques / Q000009:adverse effects
chemical_list: D001672:Biocompatible Materials; D014014:Tissue Adhesives