HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS		QUICK SEARCH:   [advanced] Author: Keyword(s): Year:  Vol:  Page:

This Article Full Text Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to Personal Folders Download to citation manager Author home page(s): Paul De Leyn Jan Wolter A. Oosterhuis Thomas Schmid Cliff K.C. Choong Walter Weder Youri Sokolow Permission Requests Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by De Leyn, P. Articles by Sokolow, Y. Search for Related Content PubMed PubMed Citation Articles by De Leyn, P. Articles by Sokolow, Y. Related Collections Lung - cancer Lung - other Pleura

J Thorac Cardiovasc Surg 2011;141:881-887
© 2011 The American Association for Thoracic Surgery

General Thoracic Surgery

Prospective European multicenter randomized trial of PleuraSeal for control of air leaks after elective pulmonary resection

^a University Hospitals Leuven, Leuven, Belgium
^b Otto Wagner Hospital, Vienna, Austria
^c VU-Medisch Centrum, Amsterdam, The Netherlands
^d Universitätsklinik–Landeskrankenhaus Innsbruck, Innsbruck, Austria
^e Papworth Hospital NHS Foundation Trust, Cambridge, United Kingdom
^f Universitaets Spital Zurich, Zurich, Switzerland
^g Hôpital Erasme, Brussels, Belgium

Received for publication May 1, 2010; revisions received July 17, 2010; accepted for publication September 24, 2010.

^_* Address for reprints: Paul De Leyn, MD, PhD, University Hospitals Leuven, Herestraat 49, 3000 Leuven, Belgium. (Email: Paul.deleyn{at}uz.kuleuven.ac.be).

Objectives: We sought to evaluate the efficacy and safety of a synthetic bioresorbable pleural sealant (PleuraSeal; Covidien, Bedford, Mass) to treat air leaks after pulmonary resection.

Methods: Patients with air leaks after lung resection were randomized to treatment with pleural sealant on air leak sites after standard methods of lung closure or standard lung closure only. The primary outcome variable was the percentage of patients remaining air leak free until discharge. The secondary outcome variables were the proportion of patients with successful intraoperative air leak sealing, time to last air leak, and durations of chest tube drainage and hospitalization.

Results: The sealant group comprised 62 subjects, and the control group comprised 59 subjects. Most patients (98.3%) underwent open lobectomy for bronchogenic carcinoma. The overall success rates for intraoperative air leak sealing were as follows: sealant group, 71.0%; control group, 23.7% (P < .001). For grade 2 and 3 air leaks (n = 77), the intraoperative sealing rates were as follows: sealant group, 71.7%; control group, 9.1% (P < .001). More patients with grade 2 and 3 air leaks had their leaks remain sealed in the sealant group (43.5% vs 15.2%, P = .013). The median time from skin closure to last observable air leak was 6 hours (sealant group) versus 42 hours (control group, P = .718). No treatment-related complications were reported. No differences in drainage or hospitalization were observed.

Conclusions: In this multicenter study the pleural sealant was safe and effective treatment for intraoperative air leaks after lung resection. Significantly fewer patients with surgically relevant intraoperative air leaks had postoperative air leaks when the pleural sealant was applied.

This article has been cited by other articles:

				P. L. Filosso, E. Ruffini, A. Sandri, P. O. Lausi, R. Giobbe, and A. Oliaro Efficacy and safety of human fibrinogen-thrombin patch (TachoSil(R)) in the treatment of postoperative air leakage in patients submitted to redo surgery for lung malignancies: a randomized trial Interact CardioVasc Thorac Surg, May 1, 2013; 16(5): 661 - 666. [Abstract] [Full Text] [PDF]

				G. Rocco Remote-Controlled, Wireless Chest Drainage System: An Experimental Clinical Setting Ann. Thorac. Surg., January 1, 2013; 95(1): 319 - 322. [Abstract] [Full Text] [PDF]

				M. J. Schuchert, G. Abbas, J. P. Landreneau, J. D. Luketich, and R. J. Landreneau Use of energy-based coagulative fusion technology and lung sealants during anatomic lung resection J. Thorac. Cardiovasc. Surg., September 1, 2012; 144(3): S48 - S51. [Abstract] [Full Text] [PDF]

				G. Cardillo, F. Carleo, L. Carbone, A. R. De Massimi, A. Lococo, P. F. Santini, A. Janni, and A. Gonfiotti Adverse effects of fibrin sealants in thoracic surgery: the safety of a new fibrin sealant: multicentre, randomized, controlled, clinical trial Eur J Cardiothorac Surg, March 1, 2012; 41(3): 657 - 662. [Abstract] [Full Text] [PDF]

				A. Gonfiotti, P. F. Santini, M. Jaus, A. Janni, A. Lococo, A. R. De Massimi, A. D'Agostino, F. Carleo, M. Di Martino, V. Larocca, et al. Safety and Effectiveness of a New Fibrin Pleural Air Leak Sealant: A Multicenter, Controlled, Prospective, Parallel-Group, Randomized Clinical Trial Ann. Thorac. Surg., October 1, 2011; 92(4): 1217 - 1225. [Abstract] [Full Text] [PDF]

				A. Hashimoto, M. Kuwabara, Y. Hirasaki, H. Tsujimoto, T. Torii, T. Nakamura, and A. Hagiwara Reduction of air leaks in a canine model of pulmonary resection with a new staple-line buttress J. Thorac. Cardiovasc. Surg., August 1, 2011; 142(2): 366 - 371. [Abstract] [Full Text] [PDF]