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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  03/19/2008
 
Trade Name:  ARTISS
 
Generic or Proper Name (*):  Fibrin Sealant (Human)*
 
Indications Studied:  To adhere autologous skin grafts to surgically prepared wound beds resulting from burns
 
Therapeutic Category:  Wound healing
 
Ages Studied:  1-16 years
 
Study #:  1
 
Study Type:  Efficacy/Safety
 
Study Design:  Single-Blind/Active Control
 
No Patients:  37
 
No Centers:  13
 
No Countries:  1
 
BPCA(B), PREA(P):  P
 
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