Randomized controlled trial of a synthetic sealant for preventing alveolarair leaks after lobectomy

Background. The intraoperative application of synthetic surgical lung seala nt (SLS) to surfaces leaking air or at risk of air leaks has been advocated to reduce alveolar air leaks (AAL) after lobectomy. Methods. This study was designed to investigate the effectiveness of SLS in reducing AAL in patients considered intraoperatively to have moderate to s evere AAL, after all conventional measures to reduce such leaks had been us ed. Over 17 months, 124 patients undergoing standard lobectomy were randomi zed to standard closure of parenchymal surgical sites, with or without SLS. Results. In treated patients, the mean numbers of intraoperative AAL after application of SLS were significantly smaller than in untreated patients (3 8.5 mL versus 59.9 mL, p = 0.0401). Postoperatively, the mean time to last observable AAL was shorter in the treated group (33.7 hours versus 63.2 hou rs, r = 0.0134) and the mean percentage of patients free of AAL at days 3 a nd 4 was smaller (87% versus 58.5%, p = 0.002). However, the occurrence of incomplete lung expansion after drain removal, and the length of the postop erative hospital stay due to prolonged AAL, were not different. In the trea tment group, 4 patients developed localized empyema and incomplete lung exp ansion without bronchopleural fistula 7, 12, 15, and 20 days, respectively, after operation. In these 4 patients, inserted chest tubes drained infecte d sealant. Conclusions. Surgical lung sealant may be a useful adjunct to conventional techniques for reducing moderate and severe AAL after lobectomy, but its us e seems to increase the risk of postoperative empyema. (Ann Thorac Surg 200 1;71:1618-22) (C) 2001 by The Society of Thoracic Surgeons.