Schenk, Worthington G. III, MD; Burks, Sandra G. BSN;
Gagne, Paul J. MD; Kagan, Steven A. MD; Lawson, Jeffrey H. MD, PhD ;
Spotnitz, William D. MD
For complete paper: Annals of Surgery. 237(6):871-876,
Objective: To evaluate the efficacy
and safety of an investigational fibrin sealant (FS) in a randomized
prospective, partially blinded, controlled, multicenter trial.
Summary Background Data: Upper extremity vascular access surgery using
polytetrafluorethylene (PTFE) graft placement for dialysis was chosen
as a reproducible, clinically relevant model for evaluating the
usefulness of FS. The FS consisted of pooled human fibrinogen (60
mg/mL) and thrombin (500 NIH U/mL). Time to hemostasis was measured,
and adverse events were monitored.
Methods: Consenting adult patients (n = 48) undergoing placement of a
standard PTFE graft were randomized in a 2:1:1 ratio to the treatment
group using FS (ZLB Bioplasma AG, Bern, Switzerland), oxidized
regenerated cellulose (Surgicel, Johnson & Johnson, New Brunswick,
NJ), or pressure. Patients received heparin (3,000 IU IVP) before
placement of vascular clamps. If the treatment was FS, clamps were left
in place for 120 seconds after the application of study material to
permit polymerization. If treatment was Surgicel, clamps were left in
place until the agent had been applied according to manufacturer's
instructions. If the treatment was pressure, clamps were released as
soon as the investigator was ready to apply compression. Immediately
after release of the last clamp, the arterial and venous suture lines
were evaluated for bleeding. The time to hemostasis at both the venous
and arterial sites was recorded.
Results: Significant (P <= .005) reduction in time to hemostasis was
achieved in the FS group. Thirteen (54.2%) patients randomized to FS
experienced immediate hemostasis at both suture lines following clamp
removal compared to no patients using Surgicel or pressure. Only one
patient (7.1%) in the Surgicel group and no patients in the pressure
group experienced hemostasis at 120 seconds from clamp removal,
compared to 13 (54.2%) patients for FS. Adverse events were comparable
in all groups. There were no seroconversions.
Conclusions: FS achieved more rapid hemostasis than traditional
techniques in this peripheral vascular procedure. FS use appeared to be
safe for this procedure.
Copyright © 2003 Lippincott Williams & Wilkins, Inc.