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A prospective randomized study to assess the efficacy of a surgical sealant to treat air leaks in lung surgery

^a Department of Thoracic Surgery, University of Rome "La Sapienza", Sant’Andrea Hospital, Via di Grottarossa 1035, 00189 Rome, Italy
^b Department of Thoracic Surgery, University of Rome "La Sapienza", Policlinico Umberto I, Rome, Italy
^c Department for Medical Informatics, Biometry, and Epidemiology, University of Munich, Germany

Received 9 September 2008; received in revised form 29 December 2008; accepted 20 January 2009.

^_* Corresponding author. Tel.: +39 0633775773; fax: +39 0633775578. (Email: adandrilli{at}hotmail.com).

Objective: A prospective, randomized study to evaluate the effectiveness and safety of a polymeric sealant (Coseal^®, Baxter Healthcare, Deerfield, IL) to reduce air leaks and to improve postoperative outcome in patients undergoing lung resection. Methods: Between November 2005 and February 2008, 203 (128 M, 75 F) patients showing moderate/severe intraoperative air leaks after pulmonary lobectomy/bilobectomy/sleeve lobectomy (110) or minor resection (segmentectomy/wedge) (93) have been prospectively enrolled and randomly assigned to receive one of the two following management strategies: suture/stapling (101 patients – standard care group (SCG)) or suture/stapling plus Coseal sealant (102 patients – Coseal group (CG)). To assess the effectiveness of the sealant the following data were registered and compared in the two groups: number of patients with air leak cessation intraoperatively, number of patients without air leaks at 24 h and 48 h, duration of air leaks, length of hospital stay. Results: No adverse event related to the sealant application occurred. Intraoperative air leak cessation rate was higher in the CG with a statistically significant difference (85.3% vs 59.4%; p < 0.001). Air leaks rate at 24 h and 48 h was significantly lower in the Coseal group (19.6% vs 40.6%; p = 0.001 at 24 h and 23.5% vs 41.6%; p = 0.006 at 48 h). Duration of air leaks was significantly shorter in the Coseal group (p = 0.01). The hospital stay was shorter in the Coseal group (mean: 5.7 ± 2.3 days vs 6.2 ± 2.5 days) but this difference did not reach statistical significance owing to the many known clinical interfering factors. Conclusions: The application of Coseal sealant proved safe and effective in reducing air leaks occurring after lung resection and in shortening the duration of postoperative air leak with a trend towards a shorter postoperative hospital stay.

Key Words: Parenchymal air leaks • Surgical sealant • Lung surgery