L-PRF in Cranial Surgery
NCT03812120 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 350
Last updated 2019-01-22
Summary
The investigators want to demonstrate in a prospective, randomized trial including 350 patients undergoing cranial surgery that the use of L-PRF is non-inferior to classical fibrin sealants.
Conditions
- Cranial Sutures; Closure
Interventions
- PROCEDURE
-
Dural closure with L-PRF
Evaluation of the safety and effectiveness of autologous blood-derived products (L-PRF) as an adjunct for dural repair
- PROCEDURE
-
Dural closure with classical fibrin sealants
Evaluation of the safety and effectiveness of classical fibrin sealants as an adjunct for dural repair
Sponsors & Collaborators
-
Universitaire Ziekenhuizen KU Leuven
lead OTHER
Principal Investigators
-
Tom Theys, Prof · UZ Leuven
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-12-01
- Primary Completion
- 2022-12-31
- Completion
- 2023-12-31
Countries
- Belgium
Study Locations
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