A prospective, randomized, controlled trial of the effectiveness of BioGlue in treating alveolar air leaks.
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.
Tansley
Patrick
P
Department of Thoracic Surgery, Royal Brompton Hospital, Sydney Street, London, United Kingdom. p.goldstraw@rbht.nhs.uk
Al-Mulhim
Faisal
F
Lim
Eric
E
Ladas
George
G
Goldstraw
Peter
P
D000328:Adult; D000368:Aged; D005260:Female; D006801:Humans; D007431:Intraoperative Complications / Q000628:therapy*; D007902:Length of Stay; D008175:Lung Neoplasms / Q000601:surgery; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011506:Proteins / Q000627:therapeutic use*; D011650:Pulmonary Alveoli; D016037:Single-Blind Method; D013908:Thoracotomy / Q000009:adverse effects*; D014014:Tissue Adhesives / Q000627:therapeutic use*
C472676:Bio-glue; D011506:Proteins; D014014:Tissue Adhesives