A Polymeric Sealant Inhibits Anastomotic Suture Hole Bleeding More Rapidly Than Gelfoam/Thrombin<subtitle>Results of a Randomized Controlled Trial</subtitle>

Abstract

Hypothesis: An experimental polymeric sealant (CoSeal [Cohesion Technologies, Palo Alto, Calif]) provides equivalent anastomotic sealing to Gelfoam (Upjohn, Kalamazoo, Mich)/thrombin during surgical placement of prosthetic vascular grafts.Design: Randomized controlled trial.Setting: Nine university-affiliated medical centers.Patients: One hundred forty-eight patients scheduled for implantation of polytetrafluoroethylene grafts, mainly for infrainguinal revascularization procedures or the creation of dialysis access shunts, who were treated randomly with either an experimental intervention (n=74) or control (n=74).Intervention: Following polytetrafluoroethylene graft placement, anastomotic suture hole bleeding was treated intraoperatively in all control subjects with Gelfoam/ thrombin. Subjects in the experimental group had the polymeric sealant applied directly to the suture lines without concomitant manual compression.Main Outcome Measures: Primary treatment success was defined as the proportion of subjects in each group that achieved complete anastomotic sealing within 10 minutes. The proportion of subjects that achieved immediate sealing and the time required to fully inhibit suture hole bleeding also were compared between treatment groups.Results: Overall 10-minute sealing success was equivalent (86% vs 80%; P=.29) between experimental and control subjects, respectively. However, subjects treated with CoSeal achieved immediate anastomotic sealing at more than twice the rate of subjects treated with Gelfoam/ thrombin (47% vs 20%; PϽ.001). Consequently, the median time needed to inhibit bleeding in control subjects was more than 10 times longer than for experimental subjects (16.5 seconds vs 189.0 seconds; P=.01). Strikingly similar findings for all comparisons were observed separately for subgroups of subjects having infrainguinal bypass grafting and for those undergoing placement of dialysis access shunts. Conclusions:The experimental sealant offers equivalent anastomotic sealing performance compared with Gelfoam/thrombin, but it provides this desired effect in a significantly more rapid time frame.

Priorities for Clinical Research in Intracerebral Hemorrhage

“…203,204 Two other popular agents are FloSeal Matrix (particulate gel foam plus thrombin; Baxter Healthcare Corp) 205 and CoSeal (a polymeric sealant; Baxter Healthcare Corp). 206 In addition, there is evidence from a prospective series that rebleeding occurs after surgical evacuation, especially if performed early. 207 Rebleeding after surgery was also reported in nonprospective clinical series and has been reported to be as high as 7.4% even in series of ICH treated with stereotactic aspiration.…”

Hydrogel Materials

“…The sealant, composed of tetra-succinimidyl-derivatized polyethylene glycol and tetra-thiol-derivatized polyethylene glycol, demonstrated adhesion to carotid arteries, collagen membranes, and PTFE grafts in vitro [65]. In subsequent clinical studies, the PEG-PEG tissue adhesive was successful in sealing suture lines of the aorta and coronary artery bypass grafts [66], as well as prosthetic vascular grafts [67]. On December 14, 2001, the commercial sealant CoSeal ® (Cohesion Technologies, Palo Alto, CA) received FDA approval as a hemostatic adjunct during vascular reconstruction surgery (Fig.…”

Clinical use of topical thrombin as a surgical hemostat

“…The effectiveness of the gelatin/thrombin combination to achieve hemostasis has been extensively studied and found to be quite effective. The different fi brin glues have also been studied in numerous surgical settings including liver resections (Schwartz et al 2004), vascular PTFE grafts (Glickman et al 2002;Taylor et al 2003), and even inguinal hernia repairs (Canonico 2003).…”