BioGlue and Peri-strips in lung volume reduction surgery: pilot randomised controlled trial.
BACKGROUND
Both tissue sealants and buttressing have been advocated to reduce alveolar air leaks from staple lines following Lung Volume Reduction Surgery (LVRS). However, the long term detrimental effects of buttressing material are increasingly apparent. We performed a pilot prospective randomised self controlled trial in patients undergoing LVRS comparing BioGlue and Peri-strips as adjuncts in preventing alveolar air-leaks.


METHODS
A pilot prospective self controlled clinical trial was conducted in patients undergoing LVRS. Each patient was treated with BioGlue on one side and pericardial buttress on the other side as an adjunct to the staple line. The sides were randomised for adjuncts with each patient acting as his own control. Duration of air leak, intercostal drainage and time to chest drain removal were the study end points.


RESULTS
10 patients undergoing the procedure were recruited between December 2005 and October 2007. There were 6 men and the mean age was 59.8 +/- 4.9 years. There was one mortality due to multi-organ failure. The BioGlue treated side had a shorter mean duration of air-leak (3.0 +/- 4.6 versus 6.5 +/- 6.9 days), lesser chest drainage volume (733 +/- 404 ml versus 1001 +/- 861) and shorter time to chest drain removal (9.7 +/- 10.6 versus 11.5 +/- 11.1 days) compared with Peri-strips.


CONCLUSIONS
This study demonstrates comparable efficacy of BioGlue and Peri-strips, however there is a trend favouring the BioGlue treated side in terms of reduction in air-leak, chest drainage volumes, duration of chest drainage and significant absence of complications. A larger sample size is needed to validate this result.
Rathinam
Sridhar
S
Regional Department of Thoracic Surgery, Birmingham Heartlands Hospital, Bordesley Green East, Birmingham, UK. srathinam@rcsed.ac.uk
Naidu
Babu V
BV
Nanjaiah
Prakash
P
Loubani
Mahmoud
M
Kalkat
Maninder S
MS
Rajesh
Pala B
PB
D001672:Biocompatible Materials / Q000627:therapeutic use*; D004867:Equipment Design; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011013:Pneumonectomy / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods*; D011183:Postoperative Complications / Q000517:prevention & control; D011446:Prospective Studies; D011506:Proteins / Q000627:therapeutic use*; D011650:Pulmonary Alveoli; D014014:Tissue Adhesives / Q000627:therapeutic use*; D016896:Treatment Outcome
C472676:Bio-glue; D001672:Biocompatible Materials; D011506:Proteins; D014014:Tissue Adhesives