COBBANA Trial
Comparison of Hemostatic effect and handling properties of Fibrillar collagen (Lyostypt®) versus Oxidized regenerated cellulose (Surgicel®) in suture hole bleeding of peripheral arterial bypass anastomosis using PTFE graft prosthesis.
Primary endpoint: Time to hemostasis.
Time to hemostasis using Lyostypt® was significantly faster compared to oxidized regenerated cellulose. Over 80% of cases suture hole bleeding stopped in less than 3 minutes using Lyostypt®, when using oxidized regenerated cellulose more then 80% of cases needed more than 5 minutes to achieve hemostasis.
Secondary endpoint: Intraoperative efficacy rating.
Lyostypt® show better adherence to bleeding site, in case repositioning was needed it was easy and possible in all cases. Only one fleece was necessary to control bleeding, showing the cost-effectiveness of Lysotypt®.
References
Baumann P et al. A randomized controlled, prospective trial to evaluate the haemostatic effect of Lyostypt® versus Surgicel® in arterial bypass anastomosis: “Cobbana” trial. Trials. 10(2009) 91.
Qerimi B, Baumann P, Hüsing J, Knaebel HP, Schumacher H. Collagen hemostat significantly reduces time to hemostasis compared to cellulose. COBBANA, a single-center randomized trial. Am J Surg. 2013; in print. Read more on pubmed >>