A polymeric sealant inhibits anastomotic suture hole bleeding more rapidly than gelfoam/thrombin: results of a randomized controlled trial.
OBJECTIVE
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.


METHODS
Randomized controlled trial.


METHODS
Nine university-affiliated medical centers.


METHODS
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).


METHODS
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.


METHODS
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%; 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.


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.
Glickman
Marc
M
Virginia Vascular Associates, 880 Kempsville Rd, Suite 1000, Norfolk, VA 23502, USA. xmmec@aol.com
Gheissari
Ali
A
Money
Samuel
S
Martin
John
J
Ballard
Jeffrey L
JL
D000714:Anastomosis, Surgical / Q000379:methods; D001672:Biocompatible Materials / Q000627:therapeutic use; D016063:Blood Loss, Surgical / Q000517:prevention & control*; D015718:Fibrin Tissue Adhesive / Q000627:therapeutic use; D005781:Gelatin Sponge, Absorbable / Q000627:therapeutic use*; D006488:Hemostasis, Surgical / Q000379:methods*; D006490:Hemostatics / Q000627:therapeutic use*; D006801:Humans; D011092:Polyethylene Glycols / Q000627:therapeutic use; D011138:Polytetrafluoroethylene / Q000627:therapeutic use*; D013537:Sutures; D013917:Thrombin / Q000627:therapeutic use*; D016896:Treatment Outcome
D001672:Biocompatible Materials; C513322:CoSeal; D015718:Fibrin Tissue Adhesive; D006490:Hemostatics; D011092:Polyethylene Glycols; D011138:Polytetrafluoroethylene; D013917:Thrombin