title: A randomized prospective multicenter trial of a novel vascular sealant.
abstract: BACKGROUND
  Increasing use of anticoagulant medications, particularly antiplatelet therapies, can increase the difficulty in obtaining adequate suture line hemostasis. Multiple vascular sealants have been used as adjuncts to surgical procedures, but none of them have been universally successful. The aim of this study was to evaluate the safety and effectiveness of a new prophylactic vascular sealant in arterial surgery.
  
  
  METHODS
  A randomized prospective multi-institutional trial was undertaken comparing ArterX Vascular Sealant (AVS) with Gelfoam Plus during open arterial reconstruction.
  
  
  RESULTS
  Three hundred thirty-one anastomotic sites in 217 patients were randomized. One hundred one of 167 (60.5%) anastomotic sites in the AVS group achieved immediate hemostasis compared with 65 of 164 (39.6%) in the control group (P = 0.001). In anastomoses with polytetrafluoroethylene grafts, 105 of 167 (62.5%) in the AVS group achieved immediate hemostasis compared with 56 of 164 (34.0%) in the control group (P < 0.001). No significant differences were noted in morbidity or mortality. Operative time was significantly less in the AVS group compared with the control group (3.2 vs. 3.8 hours, P < 0.01).
  
  
  CONCLUSIONS
  Use of AVS results in superior hemostatic effectiveness compared with Gelfoam Plus, with no difference in safety. Although no cost analysis was performed, cost savings likely resulted from significantly decreased operative time.
authors.affiliation: Division of Vascular Surgery, Mayo Clinic, Scottsdale, AZ, USA. Stone.william@mayo.edu
authors.forename: William M
authors.initials: WM
authors.lastname: Stone
authors.forename: David L
authors.initials: DL
authors.lastname: Cull
authors.forename: Samuel R
authors.initials: SR
authors.lastname: Money
mesh_terms: D000368:Aged; D001807:Blood Vessel Prosthesis; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects* / Q000295:instrumentation; D005260:Female; D005781:Gelatin Sponge, Absorbable / Q000009:adverse effects / Q000627:therapeutic use*; D005976:Glutaral / Q000009:adverse effects / Q000627:therapeutic use*; D006489:Hemostatic Techniques / Q000009:adverse effects; D006490:Hemostatics / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011138:Polytetrafluoroethylene; D019106:Postoperative Hemorrhage / Q000209:etiology / Q000517:prevention & control*; D011446:Prospective Studies; D011474:Prosthesis Design; D019651:Plastic Surgery Procedures / Q000009:adverse effects* / Q000295:instrumentation; D013536:Suture Techniques / Q000009:adverse effects; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
chemical_list: D006490:Hemostatics; D011138:Polytetrafluoroethylene; D005976:Glutaral