PURPOSE: A prospective randomized study to evaluate the effectiveness and safety of a polymeric sealant (Coseal(r)) to reduce air leaks reported by a digital chest drainage system (“DigiVentTM”), and to improve postoperative outcome in patients undergoing lung resection.
METHODS: Between March 2008 and July 2009, 125 (100 M, 25 F) patients showing moderate/severe intraoperative air leaks after pulmonary resection (n=111) or after pleural decortications with/without adesiolysis (n=76) have been prospectively enrolled and randomly assigned to receive: suture/stapling [n=65 - standard group (SG)] or suture/stapling plus Coseal [n=60 - Coseal group (CG)].
RESULTS: The overall air leakage incidence was 12.5%. In the SG the incidence of the air leakage has been higher (20%) than the patients of the CG (8.3%). In the CG the dose of application after the first leak evidence has been of 4 ml in the 86% of the cases and 8 ml in the remainder 14%. After the second verification, the persistence of air leak has been observed in 4 patients, and it has regressed with a second application of only 4 ml in drop.Intraoperative air leak cessation rate was higher in the CG with a statistically significant difference (85.3% vs 59.4%; p < 0.001). Duration of air leaks was significantly shorter in the CG (5 vs 12 days) (p = 0.01). The hospital stay was shorter in the Coseal Group (mean: 5 vs 10 days) and the chest tube withdrawal time was longer in SG (7 vs 5 days).
CONCLUSION: The application of Coseal sealant proved safe and effective in reducing air leaks (revealed by a Digital Air System) occurring after lung resection and in shortening the duration of postoperative air leak with a trend towards a shorter postoperative hospital stay.
CLINICAL IMPLICATIONS: Air leaks is objectively revealed by Digital Drainage System, Coseal(r) sealant improve quality of life and reduce hospital stay after lung resection.
DISCLOSURE: Cosimo Lequaglie, No Financial Disclosure Information; No Product/Research Disclosure Information