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Ann Thorac Surg 2001;71:1623-1629
© 2001 The Society of Thoracic Surgeons


Original article: general thoracic

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

John C Wain, MDa,*, Larry R Kaiser, MDb, David W Johnstone, MDc, Stephen C Yang, MDd, Cameron D Wright, MDa, Joseph S Friedberg, MDb, Richard H Feins, MDc, Richard F Heitmiller, MDd, Douglas J Mathisen, MDa, Murray R Selwyn, PhDe

a Division of General Thoracic Surgery, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA
b Department of General Thoracic Surgery, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, USA
c Department of Cardiothoracic Surgery, Strong Memorial Hospital, University of Rochester Medical Center, Rochester, New York, USA
d Division of Thoracic Surgery, The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
e Statistics Unlimited, Savannah, Georgia, USA

* Address reprint requests to Dr Wain, Department of Thoracic Surgery, Massachusetts General Hospital, Blake 1570, 55 Fruit St, Massachusetts General Hospital, Boston MA 02114 (Email: Jwain{at}partners.org).

Presented at the Thirty-sixth Annual Meeting of The Society of Thoracic Surgeons, Fort Lauderdale, FL, Jan 31–Feb 2, 2000.

Background. Postoperative air leaks are a major cause of morbidity after lung 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 randomized intraoperatively in a 2:1 ratio to receive surgical sealant applied to sites at risk for air leak after standard methods of lung closure (treatment group) or to have standard lung closure only (control group). The primary 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 cessation. Time to chest tube removal, time to hospital discharge, and safety outcomes were also evaluated.

Results. Air leaks were identified before randomization in 89 of 117 patients in the treatment group and in 39 of 55 patients in the control group. Application of the sealant resulted in control of air leaks in 92% of treated patients (p ≤ 0.001). A significantly higher percentage of treated patients than control patients remained free of air leaks during hospitalization (39% versus 11%, p ≤ 0.001). The mean 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, trends were observed for reduced time to chest tube removal and earlier discharge. No significant difference was identified in postoperative morbidity and mortality between the two groups.

Conclusions. Air leaks after lung resection occur in most patients. The application of this novel surgical sealant appears to be effective and safe in preventing postoperative air leaks.




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