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Eur J Cardiothorac Surg 2007;31:198-202. doi:10.1016/j.ejcts.2006.11.033
Copyright © 2007, European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. All rights reserved

Efficiency of fleece-bound sealing (TachoSil®) of air leaks in lung surgery: a prospective randomised trial

Udo Anegga,*, Jörg Lindenmanna, Veronika Matzia, Josef Smolleb, Alfred Maiera, Freyja Smolle-Jüttnera

a Division of Thoracic and Hyperbaric Surgery, University Medical School, Graz, Austria
b Institute for Medical Informatics, Statistics, and Documentation, University Medical School, Graz, Austria

Received 18 September 2006; received in revised form 21 November 2006; accepted 24 November 2006.

* Corresponding author. Tel.: +43 345273178; fax: +43 3163854679. (Email: udo{at}anegg.net).

Objective: Persistent air leakage following pulmonary resection is a major limiting factor for discharge from hospital. The aim of this study was to evaluate the sealing capacity of TachoSil® for the closure of alveolar air leaks following parenchymal resections and to determine its effect on time to chest drain removal and duration of hospitalisation. Methods: A total of 173 patients undergoing lobectomy or segmentectomy were enrolled in a single-centre, randomised study to compare the efficacy of TachoSil® with standard treatment. Alveolar air leaks were evaluated intraoperatively by submersion of the resection site in saline and were graded according to the Macchiarini scale as 0 (no bubbles), 1 (single bubbles), 2 (stream of bubbles), 3 (coalescent bubbles). Patients with grade 1 or 2 air leaks were randomised to TachoSil® or standard treatment. Grade 3 patients received standard treatment until the air leak was downgraded to grade 1 or 2 at which point they were randomised. Patients with grade 0 leakage were excluded. The primary efficacy endpoints of the study were postoperative quantification of air leakage on postoperative days 1 and 2. Other efficacy measurements included mean time to chest drain removal and mean time to hospital discharge. Results: The mean intraoperative post-treatment air leakage was significantly lower in the TachoSil® group (153.32 ml/min, range: 10–450 ml/min) compared with the standard treatment group (251.04 ml/min, range: 15–970 ml/min; P = 0.009). The significant difference in air leakage volume observed intraoperatively post-treatment was maintained postoperatively. TachoSil® showed a trend towards reduced incidence of postoperative leakage when measured >48 h or >7 days after surgery (30.7% vs 38.96% and 24% vs 32.46%, respectively). The mean times to chest drain removal and to hospital discharge were significantly reduced following the use of TachoSil® (5.1 days vs 6.3 days, P = 0.022 and 6.2 days vs 7.7 days, P = 0.01, respectively). Conclusions: The use of TachoSil® following pulmonary resection resulted in a reduction in air leakage compared with standard techniques. This reduction in air leakage resulted in a significant reduction in both the time to chest drain removal and the period of hospitalisation.

Key Words: Air leakage • Lung tissue sealing • TachoSil®




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Copyright © 2007 European Association for Cardio-Thoracic Surgery. Published by Elsevier. All rights reserved.