• Eur J Cardiothorac Surg · May 2009

    Randomized Controlled Trial

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

    • Antonio D'Andrilli, Claudio Andreetti, Mohsen Ibrahim, Anna Maria Ciccone, Federico Venuta, Ulrich Mansmann, and Erino Angelo Rendina.
    • Department of Thoracic Surgery, University of Rome La Sapienza, Sant'Andrea Hospital, Rome, Italy. adandrilli@hotmail.com
    • Eur J Cardiothorac Surg. 2009 May 1; 35 (5): 817-20; discussion 820-1.

    ObjectiveA 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.MethodsBetween 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 24h and 48h, duration of air leaks, length of hospital stay.ResultsNo 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 24h and 48h was significantly lower in the Coseal group (19.6% vs 40.6%; p=0.001 at 24h and 23.5% vs 41.6%; p=0.006 at 48h). 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.ConclusionsThe 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.

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