Trial of a novel synthetic sealant in preventing air leaks after lung resection

Background. Postoperative air leaks are a major cause of morbidity after lu ng resections. This study was designed to evaluate the efficacy and safety of a new synthetic, bioresorbable surgical sealant in preventing air leaks after pulmonary resection. Methods. In a multicenter trial, 172 patients undergoing thoracotomy were r andomized intraoperatively in a 2:1 ratio to receive surgical sealant appli ed to sites at risk for air leak after standard methods of lung closure (tr eatment group) or to have standard lung closure only (control group). The p rimary outcome variable was the percentage of patients free of air leakage throughout hospitalization. Secondary outcome variables were the control of air leaks intraoperatively and the time to postoperative air leak cessatio n. Time to chest tube removal, time to hospital discharge, and safety outco mes were also evaluated. Results. Air leaks were identified before randomization in 89 of 117 patien ts in the treatment group and in 39 of 55 patients in the control group. Ap plication of the sealant resulted in control of air leaks in 92% of treated patients (p less than or equal to 0.001). A significantly higher percentag e of treated patients than control patients remained free of air leaks duri ng hospitalization (39% versus 11%, p less than or equal to 0.001). The mea n times to last observable air leak were 30.9 hours in the treatment group and 52.3 hours in the control group (p = 0.006). In the treatment group, tr ends were observed for reduced time to chest tube removal and earlier disch arge. No significant difference was identified in postoperative morbidity a nd mortality between the two groups. Conclusions. Air leaks after lung resection occur in most patients. The app lication of this novel surgical sealant appears to be effective and safe in preventing postoperative air leaks. (Ann Thorac Surg 2001;71:1623-9) (C) 2 001 by The Society of Thoracic Surgeons.