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 24h and 48h, 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 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. 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.
RCT Entities:
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 24h and 48h, 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 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. 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.
Authors: Alexander Assmann; Andrea Vegh; Mohammad Ghasemi-Rad; Sara Bagherifard; George Cheng; Ehsan Shirzaei Sani; Guillermo U Ruiz-Esparza; Iman Noshadi; Antonio D Lassaletta; Sidhu Gangadharan; Ali Tamayol; Ali Khademhosseini; Nasim Annabi Journal: Biomaterials Date: 2017-06-06 Impact factor: 12.479