title: A prospective randomized controlled study to assess the effectiveness of CoSeal® to seal air leaks in lung surgery.
abstract: OBJECTIVE
  Prolonged alveolar air leak is the most common complication after pulmonary surgery. We conducted an investigator-led randomized trial to evaluate the effectiveness of CoSeal® surgical sealant (Cohesion Technologies Inc.; manufactured and distributed by Baxter Healthcare) for the closure of alveolar air leak after anatomical pulmonary resection.
  
  
  METHODS
  Patients undergoing primary open lobectomy, bilobectomy, or sublobar resection with a demonstrable air leak on intra-operative testing were randomized to either standard care or standard care plus application of CoSeal® surgical sealant to areas of air leak. A second application of CoSeal® was used in the treatment group if air leak persisted. Patients were allocated at the point of entry to the trial by unbiased allocation with minimization to ensure balance between the two arms with respect to age, sex, surgeon, number of segments resected, preoperative forced expiratory volume in 1s (FEV₁), and grade of air leak. Kaplan-Meier analysis of air-leak duration and a log rank test were performed on an intention-to-treat basis, with observations censored at death, transfer to the intensive care unit, or discharge.
  
  
  RESULTS
  Of the 200 patients, who entered the trial over a 24-month period, 121 with demonstrable intra-operative air leak were randomly allocated to the two groups. Data were missing for one patient in the CoSeal® group. In 57%, the air leak was stopped at the first application; a quarter continued to leak after the second. At 24h, there was no difference in air leak and fewer patients in the control group were leaking at 48 h postoperatively. By log rank test, the difference was not significant (p=0.09).
  
  
  CONCLUSIONS
  Patients treated with CoSeal® in this study had, as a group, a longer duration of air leak and hence we cannot recommend its routine use.
authors.affiliation: Department of Thoracic Surgery, Guy’s Hospital, London, UK. Carol.Tan@stgeorges.nhs.uk
authors.forename: Carol
authors.initials: C
authors.lastname: Tan
authors.forename: Martin
authors.initials: M
authors.lastname: Utley
authors.forename: Christos
authors.initials: C
authors.lastname: Paschalides
authors.forename: John
authors.initials: J
authors.lastname: Pilling
authors.forename: John Daniel
authors.initials: JD
authors.lastname: Robb
authors.forename: Karen Macmillan
authors.initials: KM
authors.lastname: Harrison-Phipps
authors.forename: Loïc
authors.initials: L
authors.lastname: Lang-Lazdunski
authors.forename: Tom
authors.initials: T
authors.lastname: Treasure
mesh_terms: D000368:Aged; D004322:Drainage; D005260:Female; D006801:Humans; D007430:Intraoperative Care / Q000379:methods; D007902:Length of Stay / Q000706:statistics & numerical data; D008297:Male; D008875:Middle Aged; D011013:Pneumonectomy / Q000009:adverse effects* / Q000379:methods; D011030:Pneumothorax / Q000209:etiology* / Q000628:therapy*; D011092:Polyethylene Glycols / Q000009:adverse effects / Q000627:therapeutic use*; D011184:Postoperative Period; D011446:Prospective Studies; D014014:Tissue Adhesives / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: C513322:CoSeal; D014014:Tissue Adhesives; D011092:Polyethylene Glycols