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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  01/25/2012
 
Trade Name:  TISSEEL
 
Generic or Proper Name (*):  Fibrin Sealant*
 
Indications Studied:  Hemostasis: An adjunct to hemostasis in patients undergoing surgery when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. TISSEEL is effective in heparinized patients. Sealing: An adjunct to standard surgical techniques (such as suture and ligature) to prevent leakage from colonic anastomoses following the reversal of temporary colostomies
 
Therapeutic Category:  Wound healing
 
Ages Studied:  6 months - 16 years
 
Study #:  1
 
Study Type:  Efficacy/Safety
 
Study Design:  Randomized/Open label, Controlled
 
No Patients:  333
 
No Centers:  11
 
No Countries:  1
 
BPCA(B), PREA(P):  P
 
Asian:  0
 
Black:  0
 
Other:  0
 
White:  0
 
Unknown:  0
 
Native Hawaiian or Pacific Islander:  0
 
American Indian/Alaska Native:  0
 
Hispanic/Latino:  0
 
Non-Hispanic/Non Latino:  0
 
Countries:  0
 
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