Evaluation of pooled fibrin sealant for ear surgery.
OBJECTIVE
This study investigated the bonding strength and tissue toxicity of a commercially prepared dual-virally-inactivated pooled-blood fibrin tissue adhesive (ViGuard-FS; Melville Biologics, Inc., NY, U.S.A.) and compared it with an autologous fibrin tissue adhesive made by the precipitation of fibrinogen using ethanol and freezing (AFTA-E).


METHODS
The bonding strength of FS was optimized by varying the concentrations of fibrinogen and human or bovine thrombin using three different surface media: inorganic (silastic), animal skin, and human dura mater. Furthermore, tissue reactions and duration of fibrin clots were studied by injecting FS into the auricles of rats.


RESULTS
This study showed that optimized FS with human thrombin was superior in bonding strength to AFTA-E on all three surface media, and that FS does not produce any toxic tissue responses when injected into rat auricles. Minimal traces of the adhesive clot could be observed in a few auricles at 35 days after application.


CONCLUSIONS
Because it is made from pooled-donor blood that has been treated with virus elimination procedures, FS is superior to autologous fibrin tissue adhesive in which fibrinogen is precipitated by the ethanol/freezing method. FS has not shown any undesirable tissue reactions when injected into live rat auricles. We believe that these results provide a rationale for further clinical development of ViGuard-FS as a tissue adhesive for otologic surgery.
Siedentop
K H
KH
Department of Otolaryngology-Head and Neck Surgery, University of Illinois at Chicago, USA.
Chung
S E
SE
Park
J J
JJ
Sanchez
B
B
Bhattacharya
T
T
Marx
G
G
D000818:Animals; D002417:Cattle; D004423:Ear / Q000601:surgery*; D015718:Fibrin Tissue Adhesive / Q000494:pharmacology*; D005340:Fibrinogen / Q000032:analysis; D006801:Humans; D066298:In Vitro Techniques; D051381:Rats; D013917:Thrombin / Q000032:analysis
D015718:Fibrin Tissue Adhesive; D005340:Fibrinogen; D013917:Thrombin