Evaluation of an absorbable cyanoacrylate adhesive as a suture line sealant.
BACKGROUND
Previous formulations of cyanoacrylate, though very effective, proved to have too high a tissue reactivity to be used internally. A novel cyanoacrylate compound with less tissue reactivity was recently developed. The objective of this study was to assess this novel cyanoacrylate compound for the use as vascular suture line sealant.


METHODS
Twelve adult female sheep received a 6 mm PTFE interposition graft in each iliac artery, for a total of 24 grafts. Using oxidized cellulose (Surgicel) as a control, two formulations of a new cyanoacrylate compound (named "compound A" and "compound B") were assessed during this trial. Hemostatic efficiency was measured at the time of operation by the assessment of bleeding time and amount of blood loss. Long-term graft patency was assessed angiographically at 4, 6, and 18 months. Tissue reaction at 2 weeks, 1, 6, and 18 months was assessed grossly by vascular surgeons and microscopically by a blinded pathologist.


RESULTS
Average time to hemostasis was 37.6, 50.6, and 219 s in group A, group B, and oxidized cellulose control groups, respectively (P<or=0.001 for both compounds versus control). There were no significant differences between groups with regards to graft patency. Histopathology analysis demonstrated mild to moderate tissue reaction at 2 weeks and 1 month in the cyanoacrylate groups compared with controls at 1 month (ANOVA P=0.004). Mild tissue reaction was seen at 6 months and 18 months, with no significant differences between groups (ANOVA P=0.08, 0.62, respectively).


CONCLUSIONS
The novel cyanoacrylate compound examined in this study is a highly effective suture line sealant with only mild tissue reactivity and no significant effects on graft patency when studied over an 18 month period.
Ellman
Peter I
PI
Department of Surgery, University of Virginia Health System, Charlottesville, Virginia 22908, USA. pie8y@virginia.edu
Brett Reece
T
T
Maxey
Thomas S
TS
Tache-Leon
Carlos
C
Taylor
Jack L
JL
Spinosa
David J
DJ
Pineros-Fernandez
Angela C
AC
Rodeheaver
George T
GT
Kern
John A
JA
D000714:Anastomosis, Surgical; D000818:Animals; D001807:Blood Vessel Prosthesis; D019917:Blood Vessel Prosthesis Implantation; D003487:Cyanoacrylates / Q000494:pharmacology*; D005260:Female; D006488:Hemostasis, Surgical / Q000379:methods*; D007083:Iliac Artery / Q000601:surgery; D011138:Polytetrafluoroethylene / Q000494:pharmacology; D012756:Sheep; D013536:Suture Techniques; D013997:Time Factors; D014014:Tissue Adhesives / Q000494:pharmacology; D016896:Treatment Outcome
D003487:Cyanoacrylates; D014014:Tissue Adhesives; D011138:Polytetrafluoroethylene