• Marc Glickman, Ali Gheissari, Samuel Money, John Martin, Jeffrey L Ballard, and CoSeal Multicenter Vascular Surgery Study Group.
• Virginia Vascular Associates, 880 Kempsville Rd, Suite 1000, Norfolk, VA 23502, USA. xmmec@aol.com
• Arch Surg Chicago. 2002 Mar 1;137(3):326-31; discussion 332.

HypothesisAn 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.DesignRandomized controlled trial.SettingNine university-affiliated medical centers.PatientsOne 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).InterventionFollowing 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 MeasuresPrimary 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.ResultsOverall 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%; P<.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.ConclusionsThe experimental sealant offers equivalent anastomotic sealing performance compared with Gelfoam/thrombin, but it provides this desired effect in a significantly more rapid time frame.

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