Lung sealant and and morbidity after pleural decortication: a prospective randomized, blinded study

Objectives: Prolonged postoperative air leaks (AL) are a major cause of morbidity. Aim of this work was evaluating use of a Lung Sealant System (Pleuraseal (TM), Covidien, Mansfield, MA, U. S. A.) in pleural decortications for empyema thoracis. Methods: From January 2008 to December 2008, 46 consecutive patients received pleural decortications for empyema thoracis. Post-procedural and malignancy-related empyemas were excluded. After hydro-pneumatic test and surgical correction of AL (until satisfaction), patients were assigned (23 per group) to Control or Sealant group. Control group underwent no additional interventions. In Sealant group, lung sealant was applied over AL areas. Following variables were measured daily: patients with AL; time to chest drainage (CD) removal; CD drainage volume at removal, postoperative length of hospital stay, postoperative C-reactive protein (CRP), and leukocyte counts. Personnel recording parameters were blinded to intervention. Two-tailed t-tests (normally distributed data) or Mann-Whitney U-test (not-normally distributed data) were used for evaluating significance of differences between group means or medians. Significance of any proportional differences in attributes were evaluated using Fisher's Exact Test. Statistical analysis was carried out using R-software (version 2.8.1). Results: Groups were similar regarding demographic and baseline characteristics. No patients were withdrawn from study; no adverse effects were recorded. There were no significative differences on CRP and leukocyte levels between two groups. Compared with the Control group, in Sealant group significantly fewer patients had AL (30 versus 78%, p = 0.012), and drains were inserted for a shorter time (medians, 3 versus 5 days, p = 0.05). Postoperative hospitalization time was shorter in Sealant group than in control group, but difference was not significant (0.7 days, p = 0.121). Conclusions: Pleuraseal T Lung Sealant System significantly reduces AL following pleural decortications for empyema and, despite of not-increased infectious indexes, is suitable for routinely use, even in procedures with contaminated pleura.