PRINT THIS PAGEClinical Studies
Improved Intraoperative Management of Anastomotic Bleeding During Aortic Reconstruction: Results of a Randomized Controlled Trial1,2
A multicenter randomized controlled trial was completed in the United States to determine the safety and effectiveness of COSEAL sealant for the control of anastomotic suture hole bleeding during aortic reconstruction procedures using prosthetic vascular grafts. The proportion of suture lines sites that achieved immediate sealing and the proportion sealed within 5 minutes were determined among 37 experimental (59 sites) and 17 control subjects (27 sites).
The results of the trial indicated that greater than 80% of the total sites treated with COSEAL sealant demonstrated immediate anastomotic sealing.
Results of Randomized Controlled Trial for Anastomotic Suture Hole Bleeding1,3
A prospective, randomized, controlled multicenter trial was conducted to evaluate the safety and effectiveness of COSEAL sealant versus an absorbable gelatin sponge/thrombin hemostat to manage anastomotic suture hole bleeding in patients undergoing placement of PTFE vascular grafts. An equivalence hypothesis was used. One hundred and forty eight (148) patients were treated with COSEAL sealant or the control at nine centers. This study was designed to evaluate whether the COSEAL success rate was equivalent to the success rate for the control.
The results indicated that overall 10-minute sealing success was similar (86% vs 89%; P=.29) between COSEAL selant and the control. However, subjects treated with COSEAL sealant achieved immediate anastomotic sealing at more than twice the rate of subjects treated with the gelatin sponge/thrombin (47% vs 20%; P<.001).
Table 4: Patients Achieving Complete Sealing
All Treated Patients [Success/Total] (%)1
Table 6: Sites Achieving Immediate Sealing
By Degree of Pretreatment Bleeding,
All Treated Sites1
Table 7: Cumulative Number of Patients with
Complete Sealing over 10 Minutes All Treated Patients (%)1
European Multicenter Study1
A multi-center non-randomized clinical study was performed in Germany and the Netherlands with 131 patients treated in 10 centers. This trial was conducted to evaluate the safety and effectiveness of COSEAL sealant to seal anastomotic suture lines in patients undergoing placement of peripheral vascular grafts using various types of graft materials.
Table 9: Patients Achieving Sealing By Graft Material
Sealed within 10 Minutes Success/Total(%)1
References
- COSEAL [Surgical Sealant] Instructions For Use, 03/2006.
- Hagberg RC, Hazim JS, Sabik J, Conte J, & Block JE. Improved intraoperative management of anastomotic bleeding during aortic reconstructions: results of a randomized controlled trial. The American Surgeon. Vol. 70:April(2004):307-311.
- Glickman M, Gheissari A, Money S, Martin J, & Ballard JL. A polymeric sealant inhibits anastomotic suture hole bleeding more rapidly than gelfoam/thrombin. Arch Surg. Vol 137:March (2002):326-331.
COSEAL is a registered trademark of Angiodevice International GmbH, used under license.
