Status:
COMPLETED
Safety and Efficacy Study of FS 4 IU VH S/D (Fibrin Sealant With 4IU/mL Thrombin, Vapor Heated, Solvent/Detergent Treated) to Adhere Split Thickness Skin Grafts and Improve Wound Healing in Burn Patients
Lead Sponsor:
Baxter Healthcare Corporation
Conditions:
Deep Partial or Full Thickness Wounds
Eligibility:
All Genders
Up to 65 years
Phase:
PHASE3
Brief Summary
The primary objective of this study is to evaluate skin graft adherence and wound healing in burn patients to evaluate whether FS 4IU VH S/D is equivalent or superior to the current standard of care (...
Eligibility Criteria
Inclusion
- Subjects or their legal representatives, who have read, understood and signed a written informed consent.
- Subjects of either sex.
- Female subjects of childbearing potential with a negative urine or serum pregnancy test on admission.
- Subjects who are \<= 65 years of age including pediatric subjects of all ages.
- Subjects with total burn wounds measuring \<= 40% TBSA.
- Subjects with a contiguous deep partial thickness/full thickness wound, between 2% and 8% TBSA or two comparable, bilateral wounds each measuring between 1% and 4% TBSA.
- Wounds designated as test sites require autologous sheet skin grafts with a thickness of 8/1000" - 16/1000"
- Subjects who are able, and willing to comply with the procedures required by the protocol.
Exclusion
- Subjects with electrical burns.
- Subjects with chemical burns
- Digits and genitalia are excluded as test sites.
- Subjects with infection at test area/test sites.
- Subjects with test sites previously randomized and treated in this study.
- Subjects with venous or arterial vascular disorder that directly affects a designated test area/test site.
- Subjects with pre-existing hemolytic anemia
- Subjects with diabetes mellitus.
- Subjects with documented history of pathologically or pharmacologically induced immune deficiency.
- Subjects judged to be chronically malnourished.
- Subjects that are judged to have significant pulmonary compromise.
- Subjects receiving systemic corticosteroids within 30 days prior to skin grafting (not including inhaled steroids).
- Subjects with known or suspected hypersensitivity to bovine proteins.
- Subjects participating in another clinical trial that is evaluating an unapproved drug or device.
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00157131
Start Date
June 1 2004
End Date
February 1 2007
Last Update
April 20 2017
Active Locations (17)
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1
Birmingham, Alabama, United States
2
Mobile, Alabama, United States
3
Phoenix, Arizona, United States
4
Orange, California, United States