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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail

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Approval Date:  01/02/2008
Trade Name:  EVICEL
Generic or Proper Name (*):  Fibrin Sealant (Human)*
Indications Studied:  Adjunct to hemostasis for use in patients undergoing surgery, when control of bleeding by standard surgical techniques is ineffective or impractical
Therapeutic Category:  Coagulant
Ages Studied:  2-16 years (retroperi-toneal and intra-abdominal surgery)
Study #:  1
Study Type:  Efficacy/Safety
Study Design:  Active Control
No Patients:  4
No Centers:  18
No Countries:  1