Status:
COMPLETED
Study of Recombinant Human Thrombin for Bleeding During Autologous Skin Grafting
Lead Sponsor:
ZymoGenetics
Conditions:
Surgical Hemostasis
Eligibility:
All Genders
2-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate whether rThrombin is safe when used for controlling bleeding during skin graft surgery.
Detailed Description
This is a Phase 2 multiple site, single-arm, open-label study designed to evaluate the safety of rThrombin in subjects of age 2 to 75 years who are receiving a partial- or full-thickness autologous sh...
Eligibility Criteria
Inclusion
- Autologous skin grafting with sheet or mesh grafts following burn or traumatic skin injury
Exclusion
- Known antibodies or hypersensitivity to thrombin or other coagulation factors
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00371215
Start Date
August 1 2006
End Date
June 1 2007
Last Update
March 9 2009
Active Locations (1)
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1
Richard M. Fairbanks Burn Center, Wishard Hospital
Indianapolis, Indiana, United States, 46202