Status:
COMPLETED
Fibrin Sealant for the Sealing of Dura Sutures
Lead Sponsor:
Baxter Healthcare Corporation
Conditions:
Pathological Processes in the Posterior Fossa
Dura Defects
Eligibility:
All Genders
3+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to investigate the efficacy and safety of FS VH S/D 500 s-apr, a double virus-inactivated biological two-component fibrin sealant, for use in posterior fossa surgery as an...
Eligibility Criteria
Inclusion
- Preoperative
- Subjects undergoing elective craniotomy / craniectomy for pathological processes in the posterior fossa (such as benign and malignant tumors, vascular malformations, and Chiari 1 malformations) that result in dura defects requiring dura substitution for closure and who are able and willing to comply with the procedures required by the protocol
- Signed and dated written informed consent from the subject or from his/her legal representative prior to any study-related procedures
- Age \>= 3 years, either gender
- Intraoperative
- Surgical Wound Classification Class I and Risk Index Category (RIC) \<= 2. Penetration of mastoid air cells during partial mastoidectomy is permitted and will be recorded.
- A patch of autologous fascia or pericranium or suturable collagen-based dura substitute was cut to size and then sutured into the dura defect.
- The hem of native dura exposed along and under the craniotomy edge is wide enough to facilitate suturing and to allow for sufficient surface area for adherence of the investigational product.
Exclusion
- Preoperative
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT00681824
Start Date
May 1 2008
End Date
March 1 2010
Last Update
June 27 2013
Active Locations (13)
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1
Duarte, California, United States
2
Sacramento, California, United States
3
San Diego, California, United States
4
Orlando, Florida, United States