Annals of vascular surgery
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
Gelatin-thrombin-based hemostatic sealant for intraoperative bleeding in vascular surgery.
Vascular surgical procedures may be prolonged because of intraoperative bleeding that is not easily controlled by cautery or suture ligation. This trial compared the ability of a new hemostat, FloSealTM Matrix (FM), with a known hemostat, Gelfoam(R) plus thrombin (GT), to control intraoperative bleeding. Patients undergoing vascular surgery procedures at four institutions were entered in the trial. ⋯ Patients were assessed for morbidity at 30 days and 6-8 weeks after the operation. Analysis was performed on an intent-to-treat basis for analysis of hemostasis at 10 min and on protocol-valid patients for analysis of time to hemostasis. From our results we concluded that for patients undergoing vascular surgery procedures, the new topical hemostat, FloSeal Matrix, provides more rapid and effective hemostasis than Gelfoam plus thrombin.