The Journal of Bone and Joint Surgery (American) 83:1503-1505 (2001)
© 2001 The Journal of Bone and Joint Surgery, Inc.
Use of Fibrin Sealant to Reduce Bloody Drainage and Hemoglobin Loss After Total Knee Arthroplasty
A Brief Note on a Randomized Prospective Trial
G. J. Wang, MD,
D. S. Hungerford, MD,
C. G. Savory, MD,
A. G. Rosenberg, MD,
M. A. Mont, MD,
S. G. Burks, BSN,
S. L. Mayers, PhD and
W. D. Spotnitz, MD
Investigation performed at University of Virginia Health
System, Charlottesville, Virginia; Good Samaritan Hospital, Baltimore,
Maryland; Hughston Sports Medicine Clinic, Columbus, Georgia; and
Midwest Orthopaedics, Chicago, Illinois
G.J. Wang, MD
S.G. Burks, BSN
S.L. Mayers, PhD
W.D. Spotnitz, MD
Tissue Adhesive Center, University of Virginia Health System,
MR4 Building, Room 3122, Charlottesville, VA 22908. E-mail address
for G.W. Wang: uvatac{at}virginia.edu
D.S. Hungerford, MD
M.A. Mont, MD
Department of Orthopaedic Surgery, Johns Hopkins University,
Professional Office Building, Suite G1, 5601 Loch Raven Boulevard,
Baltimore, MD 21239
C.G. Savory, MD
Hughston Sports Medicine Clinic, 6262 Veterans Parkway, P.O.
Box 9517, Columbus, GA 31908
A.G. Rosenberg, MD
Department of Orthopaedic Surgery, Rush-Presbyterian-St. Lukes
Medical Center, 1725 West Harrison Street, Suite 1063, Chicago,
IL 60612
Although none of the authors has received or will receive benefits
for personal or professional use from a commercial party related
directly or indirectly to the subject of this article, benefits
have been or will be received, but are directed solely to a research
fund, foundation, educational institution, or other nonprofit organization
with which one or more of the authors is associated. Funds were
received in total or partial support of the research or clinical
study presented in this article. The funding source was Omrix Biopharmaceuticals.
Background: A phase-III trial that included
fifty-three patients undergoing unilateral primary total knee arthroplasty
with cement was conducted to investigate the hemostatic efficacy
of fibrin sealant.
Methods: Following cementing of the joint, 10 mL
of fibrin sealant was sprayed onto the wound before tourniquet deflation
and wound closure. No placebo was used in the control group. All patients
received drains.
Results: Within twelve hours after the surgery,
the amount of bloody drainage was 184.5 ± 28.9
mL (mean and standard error) in the fibrin-sealant group (information
available for twenty-three patients) and 408.3 ± 54.6
mL in the control group (information available for twenty-three
patients) (p = 0.002, after adjustment for variance in
the time that the drainage was measured). On the first postoperative
day, the hemoglobin level had decreased by 20.1 ± 2.1
g/L in the fibrin-sealant group (information available
for twenty-two patients) and by 27.3 ± 2.1
g/L in the control group (information available for twenty-four
patients). After adjustment for baseline values, the decrease in
the hemoglobin level was 28.9% less in the fibrin-sealant
group than in the control group (p = 0.005, 95% confidence
limits = 10.2, 43.7). There were no seroconversions in
the fibrin-sealant group.
Conclusion: These results suggest that fibrin sealant
can safely reduce bloody drainage following total knee arthroplasty
while maintaining higher hemoglobin levels.

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