OBJECTIVE: The use of tissue glues has been advocated to reduce post-thoracotomy alveolar air leaks, but outcomes have been inconclusive. The aim of this study was to determine the effectiveness of BioGlue (CryoLife Europa Ltd, Hampshire, United Kingdom) in eliminating post-thoracotomy alveolar air leaks. METHODS: A prospective, randomized, single-blind, controlled trial was conducted in which patients were stratified according to the severity of post-thoracotomy air leak that could not be controlled by conventional surgical techniques. They were allocated to a control arm (surgical treatment only) or an interventional arm (surgical treatment and BioGlue). Duration of air leak, intercostal drainage, and hospital stay comprised primary study end points. RESULTS:From December 2002 to January 2005, 52 patients were randomized, 29 (56%) of whom were men. The mean age was 59 +/- 15 years, and other characteristics were comparable in both groups. Indications for surgery were malignancy in 46 patients (88%), carcinoid tumor in 2 patients (4%), and infective disease in 4 patients (8%). Patients in the BioGlue arm had shorter median duration of air leaks, 1 (0-2) versus 4 (2-6) days (P < .001); intercostal chest drainage, 4 (3-4) versus 5 (4-6) days (P = .012); and hospital stay, 6 (5-7) versus 7 (7-10) days (P = .004), compared with controls. No major complications were encountered using BioGlue. CONCLUSIONS: This study demonstrates clear benefit from BioGlue in the treatment of alveolar air leaks through reduction of air leak duration, chest drainage time, and hospital stay. Systematic use of BioGlue may be warranted in adult thoracic surgical procedures (except pneumonectomy and decortication) when an air leak remains after all other steps to control it have failed.
RCT Entities:
OBJECTIVE: The use of tissue glues has been advocated to reduce post-thoracotomy alveolar air leaks, but outcomes have been inconclusive. The aim of this study was to determine the effectiveness of BioGlue (CryoLife Europa Ltd, Hampshire, United Kingdom) in eliminating post-thoracotomy alveolar air leaks. METHODS: A prospective, randomized, single-blind, controlled trial was conducted in which patients were stratified according to the severity of post-thoracotomy air leak that could not be controlled by conventional surgical techniques. They were allocated to a control arm (surgical treatment only) or an interventional arm (surgical treatment and BioGlue). Duration of air leak, intercostal drainage, and hospital stay comprised primary study end points. RESULTS: From December 2002 to January 2005, 52 patients were randomized, 29 (56%) of whom were men. The mean age was 59 +/- 15 years, and other characteristics were comparable in both groups. Indications for surgery were malignancy in 46 patients (88%), carcinoid tumor in 2 patients (4%), and infective disease in 4 patients (8%). Patients in the BioGlue arm had shorter median duration of air leaks, 1 (0-2) versus 4 (2-6) days (P < .001); intercostal chest drainage, 4 (3-4) versus 5 (4-6) days (P = .012); and hospital stay, 6 (5-7) versus 7 (7-10) days (P = .004), compared with controls. No major complications were encountered using BioGlue. CONCLUSIONS: This study demonstrates clear benefit from BioGlue in the treatment of alveolar air leaks through reduction of air leak duration, chest drainage time, and hospital stay. Systematic use of BioGlue may be warranted in adult thoracic surgical procedures (except pneumonectomy and decortication) when an air leak remains after all other steps to control it have failed.
Authors: Andreas Kirschbaum; N Höchsmann; T Steinfeldt; P Seyfer; A Pehl; D K Bartsch; E Palade Journal: Lasers Med Sci Date: 2016-05-16 Impact factor: 3.161
Authors: S M Alexander; L E Mitalas; M P Gosselink; D M J Oom; D D E Zimmerman; W R Schouten Journal: Tech Coloproctol Date: 2008-08-05 Impact factor: 3.781
Authors: Jörg Zehetner; John C Lipham; Shahin Ayazi; Arzu Oezcelik; Emmanuele Abate; Weisheng Chen; Steven R Demeester; Helen J Sohn; Farzaneh Banki; Jeffrey A Hagen; Melissa Dickey; Tom R Demeester Journal: Surg Endosc Date: 2009-08-19 Impact factor: 4.584
Authors: Andreas Kirschbaum; Thorsten Steinfeldt; Andreas Gockel; Pietro Di Fazio; Karl Quint; Detlef K Bartsch Journal: Interact Cardiovasc Thorac Surg Date: 2013-09-30
Authors: Francisco Javier Pérez Lara; Jose Manuel Hernández González; Arminda Ferrer Berges; Isabel Navarro Gallego; Herman Oehling de Los Reyes; Horacio Oliva Muñoz Journal: J Gastrointest Surg Date: 2018-09-05 Impact factor: 3.452