L-PRF in Cranial Surgery

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    350
  • sponsor
    Universitaire Ziekenhuizen Leuven
Updated on 22 January 2021

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.

Description

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.

Approximately 350 patients undergoing cranial surgery will be enrolled in this randomized, controlled, single-blinded monocenter study to evaluate the safety and effectiveness of autologous blood-derived products (L-PRF and fibrinogen) compared to the fibrin sealants as an adjunct for dural repair (= primary objective).

The investigators will also evaluate if the use of L-PRF obviates the need for the use of other autologous grafts (e.g. muscle/fat), commercial collagen-based products (e.g. Tachosil) or articifial dura (=secondary objective).

Details
Condition Cranial Sutures; Closure
Treatment Dural closure with L-PRF, Dural closure with classical fibrin sealants
Clinical Study IdentifierNCT03812120
SponsorUniversitaire Ziekenhuizen Leuven
Last Modified on22 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients undergoing cranial neurosurgery whereby the dura is intentionally opened (supratentorial and infratentorial approach)
Age 18 years
Written informed consent
Willing to comply with the study schedule

Exclusion Criteria

Participation in another clinical trial with study drugs or devices
Pregnancy
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