• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail

  • Print
  • Share
  • E-mail
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
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